PAM: Of course I had the fears that come along with the- the stigma of schizophrenia. Everything
you hear on the news is always the person’s name, schizophrenic, and then this horrible thing that they’ve done.
Or that they were not med-compliant. You don’t hear the good things. You don’t
see the good things. It’s always the worst-case scenario. So, it- it’s hard the- the disconnect that people
have for the condition.
CHRISTY: My explanation of schizophrenia is that it is a mental illness and there are a lot of
stigmas that come along with it. But my daughter has this mental illness and she is coping with it. And the
stigmas, they don’t define Kelsey.
CHRISTY: Going through this, sometimes it can be so stressful and overwhelming, you got to get
some help, and don’t be afraid to do that. Because when you do, you get to relax, regroup, and you repair
yourself; and then you’re ready for more and to help them. Everybody has to recharge. It’s just like sleep, you
can’t not sleep. You’ve got to have a little bit of a break. Just know your limits. Everybody has their own list
of different relaxation techniques, and you need to utilize those to avoid burnout because you don’t want to get
burned out. You always want to be on your A game and be your best for that person.
PAM: I would tell other caregivers that no matter how overwhelmed that you are, that you have
to take the time to understand what’s going on, and you have to take the time to take care of yourself.
Everybody has a life. Everybody has a responsibility. And as a caregiver, it seems like it’s too much, but you
cannot take care of that person adequately enough if you are not taking care of yourself. It’s, when you fly,
they tell you that if you are responsible for other people and the oxygen mask drops down, put yours on first.
It’s the same thing.
CHRISTY: Advocating for your loved one is probably I think my most important job. And—she used
to not be able to advocate for herself. So, she really needed somebody that knew her, you know, like I mean I’m
her mom, that would stand up and go, “No, that’s not what Kelsey would want.”
The advice I can give regarding schizophrenia and having a loved one affected by it is just never give up. And,
yeah, this- this illness shouldn’t define that person ever. They are who they
are.
This is your loved one, you- you have to be there for them, and schizophrenia shouldn’t define them because they
are who they are, and they’re obviously a very special person.
PAM: So, some of the things that I do to prepare Dorian is I always let him know he is not this
condition. That he is a person. He is a young man. And that I may not always be beside him but that I’m always
with him.
I always have to be strong for Dorian. But I’m not an anomaly. All parents have to be strong for their kids. So,
the biggest thing is (a) you’re not alone; (b) your path may not be somebody else’s path. Take your path.
WOMAN: Dear future self…Living with schizophrenia, it’s been a journey. Remembering to take
my medication every day? Well, let’s just say it’s been a challenge. Recently, my doctor told me that, based on
my symptoms, I may be able to try a long-acting treatment that’s given just 6
times a year. I’m excited about taking it one step at a time. Today, after discussing treatment options with me,
my doctor is starting me on my ARISTADA journey. After she gets me started, I’ll receive one injection every 2
months then I won’t have to think about taking a pill for my schizophrenia every day. I am hopeful for my
future.
MALE ANNOUNCER: ARISTADA is a prescription medication used to treat adults with
schizophrenia. Once your healthcare provider starts your treatment, ARISTADA provides an option of one long-acting injection given in the muscle every 2 months by your healthcare
provider. ARISTADA may reduce your schizophrenia symptoms without requiring you to take a pill every day.
ARISTADA is not approved for patients with dementia-related psychosis. Do not
take ARISTADA if you are allergic
to aripiprazole or any of the ingredients in ARISTADA. ARISTADA can cause serious side effects.
Elderly dementia patients have an increased risk of stroke or death. Call your healthcare provider right away
about fever, stiff muscles, or confusion as these may be signs of life-threatening reactions. High cholesterol or weight gain may occur, as can
high blood sugar levels which may be fatal. Other serious side effects include uncontrolled body movements which
may be permanent, compulsive behavior, dizziness upon standing, falls, low white blood cell count, difficulty
swallowing, and seizures may occur.
WOMAN: Today, my doctor and I chose a long-acting treatment
that’s one injection every 2 months. Let’s do this.
MALE ANNOUNCER: Ask your healthcare provider if ARISTADA may be right for you.
FEMALE ANNOUNCER: IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or ARISTADA if you
are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole
have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in
the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects
including:
- Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
-
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your
healthcare provider or go to the nearest hospital emergency room right away if you have some or all
of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure
-
Uncontrolled body movements (tardive dyskinesia). ARISTADA
INITIO and ARISTADA may cause movements that
you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even
if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
-
Problems with your metabolism such as:
-
High blood sugar (hyperglycemia). Increases in blood sugar can happen in some
people who receive ARISTADA INITIO and/or ARISTADA. Extremely high
blood sugar can lead to coma
or death. If you have diabetes or risk factors for diabetes (such as being overweight or a
family history of diabetes), your healthcare provider should check your blood sugar before you
receive ARISTADA INITIO and/or ARISTADA and during your treatment
with ARISTADA.
-
-
-
Call your healthcare provider if you have any of these symptoms of high
blood sugar:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
-
- Increased fat levels (cholesterol and triglycerides) in your blood
-
Weight gain. You and your healthcare provider should check your weight
regularly.
-
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had
strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive
urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice
that you are having unusual strong urges, talk to your healthcare provider.
-
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint
when you rise too quickly from a sitting or lying position.
-
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or
dizzy when standing which
may make you at risk for falls and related injuries.
- Low white blood cell count
- Seizures (convulsions)
-
Problems controlling your body temperature. Avoid becoming too hot or dehydrated.
Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay
out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
- Difficulty swallowing
The most common side effects of ARISTADA INITIO and ARISTADA
include restlessness or feeling
like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and
ARISTADA. You should tell your healthcare provider about any side-effects
you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA
INITIO and ARISTADA affect you. ARISTADA INITIO and ARISTADA may
affect your judgment, thinking or motor skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider
about all of your medical
conditions, including if you:
-
have not taken Abilify®, Abilify Maintena®, or any aripiprazole
product before
- have or had heart problems or a stroke
-
have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare
provider should check your blood sugar before you receive ARISTADA INITIO
and/or ARISTADA and during
your treatment with ARISTADA
- have or had low or high blood pressure
- have or had seizures (convulsions)
- have or had a low white blood cell count
- have problems that may affect you receiving an injection in your buttocks or your arm
-
are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO
and/or ARISTADA will harm
your unborn baby. If you become pregnant while taking ARISTADA INITIO
and/or ARISTADA, talk to your
healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.
You can register by calling 1-866-961-2388, or
visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
-
are breastfeeding or plan to breastfeed. ARISTADA INITIO and/or ARISTADA
can pass into your breast milk.
It is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed
your baby if you receive ARISTADA INITIO and/or ARISTADA.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO and ARISTADA and other
medicines may affect each other causing possible serious side effects. Do not start or stop any medicines
after you receive ARISTADA INITIO and ARISTADA without talking to your
healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider. You are
encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
SCOTT: My son was going to graduate school out in California, and luckily, I had an opportunity
to go visit with him for about a month. I was walking down the street, and all of a sudden I see this guy riding
a bike, and he had 250 pounds worth of stuff on his bike. And he’s going down there, it looks like he’s got no
brakes, and he’s got a huge smile on his face, and I just step back and say, “I’m cranky ‘cause my coffee’s
cold, and this guy who seemingly, from my perspective, doesn’t have a lot is the happiest guy in town,
apparently.”
ROBERT: Sounds like a good morning to me. When I met Scott, I had been living on the street for
years. In my 20s, I worked as a carpenter. I had a hard time staying in one place. At one point I even abandoned
my car. I wasn’t making good decisions. I felt like things were getting worse and worse for me, mentally.
SCOTT: So, after the first time I saw Robert ride by on that bicycle, I had a real need to
meet him. Took me a couple of days, but finally I saw Robert sitting at the coffee house, and I decided to go up
to him and offer to buy him a croissant and a cup of coffee.
ROBERT: Yeah, I didn’t really know I was suffering from mental illness. To me, everything
seemed like a result of being homeless. It was hard to communicate with people. People don’t want to connect
with you when you’re homeless. It’s like you’re invisible to them. Survival was something I had to think of
often. It was hard to know the line between real danger and imaginary danger. I’ve gotten into fights and I’ve
been attacked. I slept by myself in a parking garage. I was hearing voices and I didn’t even know anybody was
there. Even though when I knew something wasn’t right in my head, I still had to deal with the homelessness.
Survival overshadowed everything. I didn’t know where to go to for help. I just wanted to find peace for myself.
SCOTT: You know, the more Robert and I talked, the more I realized what a positive person he
was. Because of my family’s history with mental illness, I knew he was dealing with something serious. I went
back to New England and Robert and I exchanged email. So, the next time I went back to California, fortunately,
I was able to hook up with Robert for a few days. On the first day when I went back to California, I spent the
night on a concrete floor in a parking garage with Robert. The second night he stayed at a hotel with me, and
the third day we checked into a mental health center. I knew this was a decision that Robert had to make for
himself, and I was there to support him.
ROBERT: At the mental health center, I met the psychiatrist. He evaluated me and talked to me
about the symptoms I was having. After we talked, the doctor diagnosed me with schizophrenia. After discussing
treatment options, the doctor recommended ARISTADA. He explained that it was given by injection and I have an
option to get it every 2 months. He talked to me about the risks and the benefits, and I decided I wanted to
give it a try.
NARRATOR: ARISTADA INITIO®
(aripiprazole lauroxil) and
ARISTADA® (aripiprazole lauroxil) may not be right for everyone.
ARISTADA INITIO is a prescription medicine given as a one-time injection and is used in combination with oral aripiprazole to start
ARISTADA treatment, or re-start ARISTADA treatment after a missed dose, when
ARISTADA is used for the treatment
of schizophrenia in adults.
ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat
schizophrenia in adults.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in
children under 18 years of age.
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Before you start treatment with ARISTADA INITIO and ARISTADA, tell your
healthcare provider if you have ever taken Abilify®, Abilify Maintena®, or
any aripiprazole product before.
People who are allergic to aripiprazole or any of the ingredients in ARISTADA should not receive ARISTADA.
People must first tolerate oral aripiprazole before receiving ARISTADA INITIO
or ARISTADA.
The most common side effects of ARISTADA INITIO and ARISTADA include
restlessness or feeling like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and ARISTADA.
You should tell your healthcare provider about any side-effects you have. When
starting ARISTADA, you may receive a one-time injection called ARISTADA INITIO
along with 30 mg of oral aripiprazole. In some cases, your doctor will have you
start with 21 days of oral
aripiprazole if ARISTADA INITIO is not right for you.
Please watch the additional Important Safety Information contained in this video.
ROBERT: Since starting ARISTADA, I’ve noticed my symptoms being reduced. This is just my
experience with ARISTADA. Yours may be different. Talk to your healthcare team about what may be best for you.
SCOTT: After taking Robert to the mental health center and getting him treatment, I went back
home. I talked to Robert almost every day and during one conversation he mentioned he might want to move to New
England.
ROBERT: I went from having a hard time of making decisions to making the biggest decision of my
life. Now, I wanted to live in a different place. Everything that I’d been carrying around on my bike, I put it
in storage. I got on the plane with one bag, and I left everything behind in California.
SCOTT: I was able to find a small cabin in the woods, and I bought it for him. It was the first
time in many years that Robert had a place of his own.
ROBERT: When I woke up in my bed in the morning, I knew I was home. I got started fixing up my
cabin.
SCOTT: When we work on the cabin together, Robert’s the expert, and he teaches me all sorts of
things about construction I didn’t know.
ROBERT: After moving to New England, I continued to receive my ARISTADA injection once a month.
Now I receive one injection every 2 months.
SCOTT: He’s working with his treatment team to stay on his treatment plan. I’ve never met
anyone so grateful to be alive.
ROBERT: Without Scott, I wouldn’t be where I am. I have my own home, I’m able to do carpentry,
and I have my own support system. I don’t know what my future holds, but I know I’ll always be able to ask for
help.
NARRATOR: IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or ARISTADA if you
are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole
have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in
the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects
including:
- Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
-
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your
healthcare provider or go to the nearest hospital emergency room right away if you have some or all
of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure
-
Uncontrolled body movements (tardive dyskinesia). ARISTADA
INITIO and ARISTADA may cause movements that
you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even
if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
-
Problems with your metabolism such as:
-
High blood sugar (hyperglycemia). Increases in blood sugar can happen in some
people who receive ARISTADA INITIO and/or ARISTADA. Extremely high
blood sugar can lead to coma
or death. If you have diabetes or risk factors for diabetes (such as being overweight or a
family history of diabetes), your healthcare provider should check your blood sugar before you
receive ARISTADA INITIO and/or ARISTADA and during your treatment
with ARISTADA.
-
-
-
Call your healthcare provider if you have any of these symptoms of high
blood sugar:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
-
- Increased fat levels (cholesterol and triglycerides) in your blood
-
Weight gain. You and your healthcare provider should check your weight
regularly.
-
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had
strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive
urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice
that you are having unusual strong urges, talk to your healthcare provider.
-
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint
when you rise too quickly from a sitting or lying position.
-
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or
dizzy when standing which
may make you at risk for falls and related injuries.
- Low white blood cell count
- Seizures (convulsions)
-
Problems controlling your body temperature. Avoid becoming too hot or dehydrated.
Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay
out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
- Difficulty swallowing
The most common side effects of ARISTADA INITIO and ARISTADA
include restlessness or feeling
like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and
ARISTADA. You should tell your healthcare provider about any side-effects
you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA INITIO and ARISTADA affect you. ARISTADA
INITIO and ARISTADA may affect your judgment, thinking or motor skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider
about all of your medical
conditions, including if you:
-
have not taken Abilify®, Abilify Maintena®, or any aripiprazole
product before
- have or had heart problems or a stroke
-
have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare
provider should check your blood sugar before you receive ARISTADA INITIO
and/or ARISTADA and during
your treatment with ARISTADA
- have or had low or high blood pressure
- have or had seizures (convulsions)
- have or had a low white blood cell count
- have problems that may affect you receiving an injection in your buttocks or your arm
-
are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO
and/or ARISTADA will harm
your unborn baby. If you become pregnant while taking ARISTADA INITIO
and/or ARISTADA, talk to your
healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.
You can register by calling 1-866-961-2388, or
visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
-
are breastfeeding or plan to breastfeed. ARISTADA INITIO and/or ARISTADA
can pass into your breast milk.
It is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed
your baby if you receive ARISTADA INITIO and/or ARISTADA.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO and ARISTADA and other
medicines may affect each other causing possible serious side effects. Do not start or stop any medicines
after you receive ARISTADA INITIO and ARISTADA without talking to your
healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider. You are
encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
KEIRA: I like writing because you can go anywhere, be anything, be anyone. It’s helped me have
a safe and healthy outlet to express myself. I don’t really remember a time in my life where I didn’t have any
symptoms. I have always struggled with paranoia, anxiety, and depression. When I was younger, I didn’t realize
really anything was wrong. It was really when I started getting older, I realized it wasn’t what other people
experience. That’s when my writing became extremely dark. The voices in my head and the hallucinations got
really bad.
JENNIFER: Keira was always extremely smart. She read and could write before she was 3. But very
timid. She didn’t engage in conversation unless somebody spoke to her, but I just thought she was an introvert
and didn’t think anything was wrong until her junior year of high school. When she was 17, she went away in the
summertime for a few weeks, and I saw a different side of her. She was writing me some letters, you know, and
sending me messages that I thought were really dark. And when she returned home, things just continued to get
worse.
KEIRA: I remember that I had a really bad breakdown my senior year of high school. And that’s
when I had my first hospitalization. After that, I was in and out of the hospital constantly. At first doctors
thought it was just depression and anxiety. Then the diagnoses kept changing over time. It was a really dark
chapter of my life.
JENNIFER: Keira didn’t show any emotion. She walked around with a flat affect. The paranoia got
worse. Her writings became really scary. She was becoming violent and started hurting herself. Everyone assumed
she was just on drugs or alcohol, it was really frustrating. It made me realize there is such need for education
on this topic, especially in her age group. I’m an ER nurse, so I know the drill. I knew she wasn’t taking
drugs, so I kept pressing for answers.
KEIRA: When I was first hospitalized, I wasn’t completely open and honest with the nurses and
doctors, because the voices in my head told me not to talk about them, and I was scared. In the summer of 2019,
when I was 25 years old, I was hospitalized again. I decided to finally be more open and honest to get the
proper help I needed. I realized the doctors and the nurses there were all just trying to help me. The
psychiatrist at the hospital took some time to evaluate me. He talked to me about the symptoms I was having and
then diagnosed me with schizophrenia. I was afraid, but I also had a sense of relief to finally know what was
going on. I think deep down I had always suspected, but I just didn’t want to admit it.
JENNIFER: I didn’t understand schizophrenia and what it would mean for my daughter’s future.
And then, we found out about ARISTADA.
KEIRA: The psychiatrist who diagnosed me with schizophrenia recommended ARISTADA. He told us
ARISTADA is an injection with an option to receive it every 2 months. He told us about all the benefits and the
risks, and after discussing it with my mom, I decided to try it.
NARRATOR: ARISTADA INITIO®
(aripiprazole lauroxil) and
ARISTADA® (aripiprazole lauroxil) may not be right for everyone.
ARISTADA INITIO is a prescription medicine given as a one-time injection and is used in combination with oral aripiprazole to start
ARISTADA treatment, or re-start ARISTADA treatment after a missed dose, when
ARISTADA is used for the treatment
of schizophrenia in adults.
ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat
schizophrenia in adults.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in
children under 18 years of age.
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Before you start treatment with ARISTADA INITIO and ARISTADA, tell your
healthcare provider if you have ever taken Abilify®, Abilify Maintena®, or
any aripiprazole product before.
People who are allergic to aripiprazole or any of the ingredients in ARISTADA should not receive ARISTADA.
People must first tolerate oral aripiprazole before receiving ARISTADA INITIO
or ARISTADA.
The most common side effect of ARISTADA INITIO and ARISTADA includes feeling
like you need to move to stop
unpleasant feelings (akathisia). Tell your healthcare provider if you have any side effect that bothers you or
does not go away.
When starting ARISTADA, you may receive a one-time injection called ARISTADA
INITIO along with 30 mg of oral
aripiprazole. In some cases, your doctor will have you start with 21 days of oral aripiprazole if ARISTADA INITIO is not right for you.
Please watch and consider the additional Important Safety Information contained in this video.
KEIRA: I started treatment and stayed in the hospital for about 2 weeks. I was released and
then had a follow-up with my nurse shortly after, who I continue to see on an
ongoing basis. I like
that I don’t
have to remember to take a pill every day. A nurse gives me my injections at home. Since starting on ARISTADA,
I’ve noticed an improvement in my symptoms. This has just been my experience on ARISTADA. Yours may be
different. Talk to your healthcare team about what may be best for you.
JENNIFER: I’m happy to see her doing better. She’s working with her healthcare team to stay on
her treatment plan.
KEIRA: I do still have bad days every once in a while. But I have learned better coping skills
and how to handle them better. It’s easier to talk about what I’m going through now. If I’m having a bad day, I
talk to my mom, my best friend, or my brother. I’m getting back into volunteering at a horse farm, and I really
enjoy my job as a dog groomer. In the future, I’d like to open my own dog grooming shop and publish a book.
JENNIFER: My advice to other families and caregivers going through this is to seek help. Keep
pushing, you know. Don’t settle for an answer you don’t understand.
KEIRA: Thinking about the future is still very new to me. I’d tell my future self to keep her
head up. Be proud of how far you’ve come. Let go of the past and just keep moving forward. The next chapter of
my journey is unwritten. I don’t know what’s to come, and that’s okay.
NARRATOR: IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or ARISTADA if you
are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole
have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in
the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects
including:
- Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
-
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your
healthcare provider or go to the nearest hospital emergency room right away if you have some or all
of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure
-
Uncontrolled body movements (tardive dyskinesia). ARISTADA
INITIO and ARISTADA may cause movements that
you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even
if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
-
Problems with your metabolism such as:
-
High blood sugar (hyperglycemia). Increases in blood sugar can happen in some
people who receive ARISTADA INITIO and/or ARISTADA. Extremely high
blood sugar can lead to coma
or death. If you have diabetes or risk factors for diabetes (such as being overweight or a
family history of diabetes), your healthcare provider should check your blood sugar before you
receive ARISTADA INITIO and/or ARISTADA and during your treatment
with ARISTADA.
-
-
-
Call your healthcare provider if you have any of these symptoms of high
blood sugar:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
-
- Increased fat levels (cholesterol and triglycerides) in your blood
-
Weight gain. You and your healthcare provider should check your weight
regularly.
-
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had
strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive
urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice
that you are having unusual strong urges, talk to your healthcare provider.
-
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint
when you rise too quickly from a sitting or lying position.
-
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or
dizzy when standing which
may make you at risk for falls and related injuries.
- Low white blood cell count
- Seizures (convulsions)
-
Problems controlling your body temperature. Avoid becoming too hot or dehydrated.
Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay
out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
- Difficulty swallowing
The most common side effects of ARISTADA INITIO and ARISTADA
include restlessness or feeling
like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and
ARISTADA. You should tell your healthcare provider about any side-effects
you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA INITIO and ARISTADA affect you. ARISTADA
INITIO and ARISTADA may affect your judgment, thinking or motor skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider
about all of your medical
conditions, including if you:
-
have not taken Abilify®, Abilify Maintena®, or any aripiprazole
product before
- have or had heart problems or a stroke
-
have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare
provider should check your blood sugar before you receive ARISTADA INITIO
and/or ARISTADA and during
your treatment with ARISTADA
- have or had low or high blood pressure
- have or had seizures (convulsions)
- have or had a low white blood cell count
- have problems that may affect you receiving an injection in your buttocks or your arm
-
are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO
and/or ARISTADA will harm
your unborn baby. If you become pregnant while taking ARISTADA INITIO
and/or ARISTADA, talk to your
healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.
You can register by calling 1-866-961-2388, or
visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
-
are breastfeeding or plan to breastfeed. ARISTADA INITIO and/or ARISTADA
can pass into your breast milk.
It is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed
your baby if you receive ARISTADA INITIO and/or ARISTADA.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO and ARISTADA and other
medicines may affect each other causing possible serious side effects. Do not start or stop any medicines
after you receive ARISTADA INITIO and ARISTADA without talking to your
healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider. You are
encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
KELSEY: Growing up in school, I had problems where I wasn’t understanding people and I was, you
know, bullied. I had a really hard time making friends. They would distance themselves from me, and I really
honestly didn’t know why. Going through those years, those are kind of like the most important years of your
life where you’re kind of developing and everything, and I didn’t really have the friends around me that I guess
I could say needed.
CHRISTY: First time I noticed there was something a little amiss with Kelsey was, I believe, in
elementary school. Kelsey was having problems with processing, and her teacher noticed it too; the
misinterpretation of what one of the kids would say to her, and she would take it all wrong and get offended as
though she didn’t process it correctly.
KELSEY: When I started hearing voices first, I can think back to about when I was in grade
school. I thought that what I was feeling was normal, so I didn’t think to tell anybody. As I got older, the
symptoms continued to get worse and worse. The voices were louder and louder. I was seeing things, and I was
having really bad delusional thoughts.
CHRISTY: I had no idea. She never, ever once said to me that she was hearing voices as a child,
whatsoever. Not ‘til she was 20. I remember when Kelsey was talking to the walls. She was also talking to a mop
and thought it was her friend. I was extremely scared.
KELSEY: My initial breakdown was when I was 20 years old. I thought I was having a heart
attack. And so, I called the ambulance, and that’s how I wound up in the hospital. It kind of was just a
downward spiral after that, where it was hospital after hospital. And eventually, a psychiatrist diagnosed me
with schizophrenia. I was still in denial. I didn’t feel like that was the truth. Took me about 2 years to
accept my condition.
CHRISTY: I was devastated and complete disbelief. I didn’t understand it. I did a lot of
research and found out that we have a family history of schizophrenia. Knowing that Kelsey had schizophrenia was
incredibly hard for me to digest, and I could only focus on getting her the proper help. It was extremely
important for us to find the right doctor and the right medication for Kelsey.
KELSEY: I had tried several medications before my psychiatrist introduced me to ARISTADA. She
explained that ARISTADA is a injection given by a healthcare professional, and given my medical history, she
thought I would be an appropriate candidate to try this treatment. She went ahead and she told me the risks and
also the benefits, and after careful consideration, we decided that ARISTADA may be a good option for me.
NARRATOR: ARISTADA INITIO®
(aripiprazole lauroxil) and
ARISTADA® (aripiprazole lauroxil) may not be right for everyone.
ARISTADA INITIO is a prescription medicine given as a one-time injection and is used in combination with oral aripiprazole to start
ARISTADA treatment, or re-start ARISTADA treatment after a missed dose, when
ARISTADA is used for the treatment
of schizophrenia in adults.
ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat
schizophrenia in adults.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in
children under 18 years of age.
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Before you start treatment with ARISTADA INITIO and ARISTADA, tell your
healthcare provider if you have ever taken Abilify®, Abilify Maintena®, or
any aripiprazole product before.
People who are allergic to aripiprazole or any of the ingredients in ARISTADA should not receive ARISTADA.
People must first tolerate oral aripiprazole before receiving ARISTADA INITIO
or ARISTADA.
The most common side effects of ARISTADA INITIO and ARISTADA include
restlessness or feeling like you need to
move (akathisia). These are not all the possible side effects of ARISTADA
INITIO and ARISTADA. You should tell
your healthcare provider about any side-effects you have.
When starting ARISTADA, you may receive a one-time injection called ARISTADA INITIO along with 30 mg of oral
aripiprazole. In some cases, your doctor will have you start with 21 days of oral aripiprazole if ARISTADA INITIO is not right for you.
Please watch the additional Important Safety Information contained in this video.
KELSEY: My doctor provided me with an overview of ARISTADA and told me I had the option of
getting an injection every 2 months. I’ve been on the 2-month dosing plan, and
it’s working well for me and my
schedule. My doctor stressed the importance of sticking to my prescription schedule. She told me if I missed a
dose for some reason, I should call her right away and discuss what to do next. Since being on treatment with
ARISTADA, my schizophrenia symptoms have improved. Remember, though, this is my experience on ARISTADA, and your
experience may be different. Living with schizophrenia can be tough. I do have difficult days still. I like to
talk to my mom. She’s an angel. She completely stood by my side and never—she never let go, and she never gave
up on me. You know, she really is my rock.
CHRISTY: I have never stopped fighting for my child. I fought to get the right team of doctors,
and it’s paid off. She’s doing very well. She is working and hopes to move into a place of her own. I am so
incredibly proud of her and how she is doing.
KELSEY: This disease carries a big stigma with it where people may judge you.
Something I would say to somebody who was just diagnosed with schizophrenia is, don’t give up. Because there is
somebody out there that cares. Everybody’s special and everybody has a place in this world. Never give up.
There’s hope at the end of the tunnel.
NARRATOR: IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and
ARISTADA are not for the treatment of people who have lost touch with reality (psychosis) due to confusion
and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or ARISTADA if you
are allergic to
aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole have ranged from rash,
hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling
of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects including:
- Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
-
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your
healthcare provider or go to the nearest hospital emergency room right away if you have some or all
of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure
-
Uncontrolled body movements (tardive dyskinesia). ARISTADA
INITIO and ARISTADA may cause
movements that
you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even
if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
-
Problems with your metabolism such as:
-
High blood sugar (hyperglycemia). Increases in blood sugar can happen in some
people who receive ARISTADA INITIO and/or ARISTADA. Extremely high
blood sugar can lead to coma
or death. If you have diabetes or risk factors for diabetes (such as being overweight or a
family history of diabetes), your healthcare provider should check your blood sugar before you
receive ARISTADA INITIO and/or ARISTADA and during your treatment
with ARISTADA.
-
-
-
Call your healthcare provider if you have any of these symptoms of high
blood sugar:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
-
- Increased fat levels (cholesterol and triglycerides) in your blood
-
Weight gain. You and your healthcare provider should check your weight
regularly.
-
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had
strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive
urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice
that you are having unusual strong urges, talk to your healthcare provider.
-
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint
when you rise too quickly from a sitting or lying position.
-
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or dizzy when standing which
may make you at risk for falls and related injuries.
- Low white blood cell count
- Seizures (convulsions)
-
Problems controlling your body temperature. Avoid becoming too hot or dehydrated.
Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay
out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
- Difficulty swallowing
The most common side effects of ARISTADA INITIO and ARISTADA
include restlessness or feeling
like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and
ARISTADA. You should tell your healthcare provider about any side-effects
you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA
INITIO and ARISTADA affect you. ARISTADA INITIO and ARISTADA may affect your
judgment, thinking or motor
skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider
about all of your medical
conditions, including if you:
-
have not taken Abilify®, Abilify Maintena®, or any aripiprazole
product before
- have or had heart problems or a stroke
-
have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare
provider should check your blood sugar before you receive ARISTADA INITIO
and/or ARISTADA and during
your treatment with ARISTADA
- have or had low or high blood pressure
- have or had seizures (convulsions)
- have or had a low white blood cell count
- have problems that may affect you receiving an injection in your buttocks or your arm
-
are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO
and/or ARISTADA will harm
your unborn baby. If you become pregnant while taking ARISTADA INITIO
and/or ARISTADA, talk to your
healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.
You can register by calling 1-866-961-2388, or
visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
-
are breastfeeding or plan to breastfeed. ARISTADA INITIO and/or ARISTADA
can pass into your breast milk.
It is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed
your baby if you receive ARISTADA INITIO and/or ARISTADA.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO
and ARISTADA and other
medicines may affect each other causing possible serious side effects. Do not start or stop any medicines
after you receive ARISTADA INITIO and ARISTADA without talking to your
healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider. You are
encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
KELSEY: My desire to get better, you know, was greater than the needle. So, I decided to go
ahead and tough up and go ahead and get that shot.
JULIAN: But if you’re taking all the medicines then it’s more of a reminder; you have to do it
every day. You have to take your medicine every day. You have to take a pill every day. I’m not scared of
needles, so I don’t have any problem with it. Do the research and see what other people have said about it. To
people out there thinking of getting an injectable, just give it a shot.
KELSEY: Big realization for me that I needed to be on medication would be when I wasn’t
actually
taking it. Those moments I weren’t taking my medicine, I would be in the hospital. They would start me on
medicine there. And I’d come out of it, be released, be on my medicine for a little bit and then kind of the
same cycle. When I wasn’t on my medicine, I would feel really bad. You know, I felt like symptoms were worse and
I just wasn’t myself. I got to that point where, you know, the realization of these symptoms are getting really
bad and I don’t like the way I feel.
JULIAN: Every day, all day I work with computers. I usually get hundreds of computers. If
there’s a problem with the computer, we try to fix the computer. I would hope to go back to school and finish my
degree in information technology. I wasn’t able to finish college because it turns out I needed to be fixed
myself. I started to have problems when I couldn’t concentrate. Like, I would have like rapid thoughts. I would
like be like anxious or stressed, and I would be angry, like I got real angry.
JOSE: Julian’s mother and I split up when he was around five, and he lived with his mom for most
of his life—till his early twenties. He came to live with my sister and
I, and he enrolled in college
here. I started noticing a difference in his behavior—around a few months
after he got into college. There
was something different in his eyes.
JULIAN: I really didn’t have an idea what was going on with me. The paranoia got worse and
worse. And then after a while, I started seeing things and hearing things. I was feeling like rage. I told my
aunt that I was feeling aggravated, and after that she said I should go to the hospital. I went to the hospital
and they evaluated me. They gave me some medication. They released me, but my symptoms just kept getting worse
and worse. Sometimes I would wake up and like see things, like geometric shapes and stuff— like in the
floor or like in the wall. And I also had like an episode when I was— there was a fire extinguisher, and
then I started seeing like the bull and the eagle, and I got angry. So, I started to write the bad thoughts that
I was having in my journal.
JOSE: He ended up giving my sister a journal for her to read to see what she thought of it, and
it was very concerning for her. There was one incident—it was violent. He ended up breaking my nephew’s
guitar on the concrete—just smashing it. We didn’t know what to do.
JULIAN: The next day we went to the hospital. After evaluating me throughout the week and
discussing all my symptoms, the doctor said that I have schizophrenia. I was in denial for a while.
JOSE: The accepting part was very difficult for him. He was fighting it for a long time, and he
did not want to take medicine. Until one day, we’re driving in the car, and I think he was planning on moving.
And I told him, “Julian, you can run all you want, but you can’t run away from your mind.”
JULIAN: I couldn’t deny it anymore. I knew I needed help. So, I started reading about
schizophrenia online. I tried a couple different treatments, and then my doctor introduced me to ARISTADA. She
said that ARISTADA is an injection I had the option to get at her office every 2 months. She said it may help me
with my symptoms. After talking about the benefits and the risks, I decided to try it out.
NARRATOR: ARISTADA INITIO® (aripiprazole lauroxil) and
ARISTADA® (aripiprazole lauroxil) may not be right for everyone.
ARISTADA INITIO is a prescription medicine given as a one-time
injection and is used in combination with oral aripiprazole to start ARISTADA treatment, or re-start ARISTADA treatment after a missed dose, when ARISTADA is used for the
treatment of schizophrenia in adults.
ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat
schizophrenia in adults.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in
children under 18 years of age.
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Before you start treatment with ARISTADA INITIO and ARISTADA, tell your
healthcare provider if you have ever taken Abilify®, Abilify Maintena®, or any aripiprazole product before. People who are allergic to
aripiprazole or any of the ingredients in ARISTADA should not receive ARISTADA. People must first tolerate oral
aripiprazole before receiving ARISTADA INITIO or ARISTADA.
The most common side effects of ARISTADA INITIO and ARISTADA include
restlessness or feeling like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and ARISTADA. You should tell your healthcare provider about any
side-effects you have.
When starting ARISTADA, you may receive a one-time injection called ARISTADA INITIO along with 30 mg of oral
aripiprazole. In some cases, your doctor will have you start with 21 days of oral aripiprazole if ARISTADA INITIO is not right for you.
Please watch the additional Important Safety Information contained in this video.
JULIAN: I am doing well on ARISTADA. My schizophrenia symptoms have improved. And I feel lucky
to have support from my dad and my aunt. I really like that ARISTADA is an injection. I don’t have to remember
to take pills every day. I know that this is an ongoing process, so I’m continuing to work with my healthcare
team and my doctor. I’m continuing to work with computers, and I enjoy my job. I try to hang out with my
coworkers and not isolate myself. We just go to the movies and just hang out at their houses and stuff. I go to
support group every third Monday. It’s helpful to hear the stories. It’s like kind of knowing that you’re not
alone out there.
JOSE: He’s working with his doctor and he is staying on top of his treatments. I’m extremely
proud of Julian. It’s just to see him smile and enjoy himself and be around people and see the Julian that I
see, it’s really great. I’m happy for him. My advice to anybody going through this is just be there when they
need you. Just have to be very patient with the person you’re trying to help.
JULIAN: For me, accepting my diagnosis was very important because I could move forward. It was
kind of hard for me to open up to people at first about my condition. But when I did, I felt better. I wanna
move forward and continue my education in cyber security, and I hope to advance my career. I feel hopeful about
my future.
NARRATOR: IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at
increased risk of death when treated with antipsychotic medicines including ARISTADA INITIO and ARISTADA. ARISTADA
INITIO and ARISTADA are not for the treatment of people who have lost touch with reality
(psychosis) due to confusion and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or
ARISTADA if you are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic
reactions to aripiprazole have ranged from rash, hives and itching to anaphylaxis, which may include difficulty
breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects including:
- Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
-
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your
healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the
following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure
- Uncontrolled body movements (tardive dyskinesia). ARISTADA
INITIO and ARISTADA may cause movements that you cannot control in your face, tongue, or other
body parts. Tardive dyskinesia may not go away, even if you stop receiving ARISTADA. Tardive dyskinesia may
also start after you stop receiving ARISTADA.
-
Problems with your metabolism such as:
- High blood sugar (hyperglycemia). Increases in blood sugar can happen in some
people who receive ARISTADA INITIO and/or ARISTADA. Extremely high
blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as
being overweight or a family history of diabetes), your healthcare provider should check your blood
sugar before you receive ARISTADA INITIO and/or ARISTADA and during
your treatment with ARISTADA.
-
-
-
Call your healthcare provider if you have any of these symptoms of high blood
sugar:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
-
- Increased fat levels (cholesterol and triglycerides) in your blood
- Weight gain. You and your healthcare provider should check your weight regularly.
- Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had
strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive
urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that
you are having unusual strong urges, talk to your healthcare provider.
- Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when
you rise too quickly from a sitting or lying position.
- Falls. ARISTADA INITIO and ARISTADA may make you sleepy or
dizzy when standing which may make you at risk for falls and related injuries.
- Low white blood cell count
- Seizures (convulsions)
- Problems controlling your body temperature. Avoid becoming too hot or dehydrated.
Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out
of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
- Difficulty swallowing
The most common side effects of ARISTADA INITIO and
ARISTADA include restlessness or feeling like you need to move (akathisia). These are not all the
possible side effects of ARISTADA INITIO and ARISTADA. You should tell your
healthcare provider about any side-effects you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how
ARISTADA INITIO and ARISTADA affect you. ARISTADA
INITIO and ARISTADA may affect your judgment, thinking or motor skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare
provider about all of your medical conditions, including if you:
- have not taken Abilify®, Abilify Maintena®, or any aripiprazole product before
- have or had heart problems or a stroke
- have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare
provider should check your blood sugar before you receive ARISTADA INITIO
and/or ARISTADA and during your treatment with ARISTADA
- have or had low or high blood pressure
- have or had seizures (convulsions)
- have or had a low white blood cell count
- have problems that may affect you receiving an injection in your buttocks or your arm
- are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO
and/or ARISTADA will harm your unborn baby. If you become pregnant while taking ARISTADA INITIO and/or ARISTADA, talk to your healthcare provider about
registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388, or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
- are breastfeeding or plan to breastfeed. ARISTADA INITIO and/or ARISTADA
can pass into your breast milk. It is not known if it may harm your baby. Talk to your healthcare provider
about the best way to feed your baby if you receive ARISTADA INITIO and/or
ARISTADA.
Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
ARISTADA INITIO and ARISTADA and other medicines may affect each other causing
possible serious side effects. Do not start or stop any medicines after you receive ARISTADA INITIO and ARISTADA without talking to your healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider. You are
encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
KELSEY: It’s important to have a good healthcare team because, you know, my
healthcare team is like my second family basically. I talk to my psychiatrist about everything and, and ask I
questions about the medicine. And or if I ever have some weird thought or whatever it is, and I feel totally
comfortable. And I feel like having a positive helpful healthcare team is very important to have when you’re
going down this road with schizophrenia. I feel like my nurse practitioner, she finds the time to fit me in her
schedule. And it’s very important especially when you’re dealing with a mental disease because, you have all
these fears and worries. And to have somebody who is willing to work with you, I feel is very important. I do
have a case manager, and she is also is very helpful. We talk about, you know, life skills. And there’s this
thing how she taught me how to if I get nervous just to do the self-talks and
kind of like calmly calm myself down and everything. And this has been a big help, and I feel like she’s been a
big help in my life too. I did see a great benefit of going to my appointments even when I’m not receiving my
injection. Because I’m able to, you know, one, catch up with my psychiatrist and see how it’s going, and then,
you know, of course ask questions if I have any.
KELSEY: Sometimes when you have a lot of stress and chaotic things going on, you know, you just
need to take a break. And to me the beach is really calming and really relaxing, so I like to go down there. I
like to look at the beach and it’s like my serene—like my quiet place I guess you could say. You know, I like to
go and just think, like sit on the beach and, you know, think about life. And when I’m really stressed out, I
just take a little walk down to the beach. My mom is my rock, but, you know, some people might have friends and,
you know, coworkers or somebody else. You know, and I just think it’s important to have somebody on your side.
And, you know, having confidence in the person that is on your side and trusting them is obviously important. I
know that my mom will never ever stop fighting for me.
JULIAN: I like to play video games or write, watch Netflix, a lot of
stand-up comedy, stuff like that. Well, it’s important to have family around. Like my aunt, my
uncle, and my father, they’re really supportive of me. So, they’ve been there throughout the whole journey; so
them being there actually helps a lot. So, I’m grateful for that.
PAM: Dorian growing up—he was always caring, energetic, always up and down the court with his
friends—on his bike, with a football in hand. Dorian has always been stubborn.
He has always been strong-willed. It’s part of him. Dorian was always a great
kid and still is. I never noticed anything was off with Dorian when he was younger. Now that I look back, there
probably was some little things that were off. It wasn’t until his freshman year of college that I started
noticing he was really having issues. He wouldn’t communicate the way he would. He would look right at me, and I
would say, “Could you do x, y and z,” and he would forget. His coaches and teachers noticed something wasn’t
right as well. There was one particular time that Darian, who is Dorian’s younger brother, called me at work
saying, could I come home, because Dorian was outside yelling at the mailbox and yelling at the sun saying that
it was speaking to him. And I’m like, something isn’t right. I started thinking he was using drugs. So, the next
step we did, because Dorian was still having symptoms—we were going to a
therapist. The therapist pulled me aside after meeting with Dorian and said he thought Dorian was showing signs
of schizophrenia. What do you do with that? How do you move forward? All the things that you want in life for
your kids—is hampered. What do you tell your son? He knows life is different,
but what do you tell him? And then doing it all by yourself. People say they understand, but they don’t. They
don’t live it. We made an appointment to see a psychiatrist. The appointment was maybe a month away, but his
symptoms are getting louder—they’re advancing. We finally decided to go to the hospital. After Dorian was in the
hospital for several weeks and seeing a psychiatrist several times—and discussing his symptoms with the
psychiatrist, he was diagnosed with schizophrenia. After getting the diagnosis for Dorian having schizophrenia,
I couldn’t be in denial. If I’m in denial, I can’t get him help. I did a lot of research. I start using the
internet, just trying to figure out therapy. How could he live? What do we do? I personally started going to
support groups via NAMI. I started sitting in and asking questions from other parents and other caregivers. I
also started going to therapy myself. I wanted to be in the best state of mind so I can help my son. I have to
take care of myself mentally, just to be able to take care of Dorian. It’s a lot. He requires a lot. It was very
important to me, after doing my research—for me to find the right treatment for
Dorian. Dorian tried out a couple of treatments, but he was having some side effects. So we talked to his doctor
about the possibility of adjusting things. Dorian’s doctor presented us with the possibility of a treatment plan
with ARISTADA. He told us that ARISTADA was an injection instead of a pill. So we talked about the risks and the
benefits of Dorian trying ARISTADA, and we decided to give it a try.
NARRATOR: ARISTADA INITIO®
(aripiprazole lauroxil) and
ARISTADA® (aripiprazole lauroxil) may not be right for everyone.
ARISTADA INITIO (aripiprazole lauroxil) is a prescription medicine given as a
one-time injection and is used in combination with oral
aripiprazole
to start
ARISTADA treatment, or re-start ARISTADA treatment after a missed dose, when
ARISTADA is used for the treatment
of schizophrenia in adults.
ARISTADA (aripiprazole lauroxil) is a prescription medicine given by injection by a healthcare professional and
used to treat schizophrenia in adults.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in
children under 18 years of age.
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Before you start treatment with ARISTADA INITIO and ARISTADA, tell your
healthcare provider if you have ever taken Abilify®, Abilify Maintena®, or
any aripiprazole product before.
People who are allergic to aripiprazole or any of the ingredients in ARISTADA should not receive ARISTADA.
People must first tolerate oral aripiprazole before receiving ARISTADA INITIO
or ARISTADA.
The most common side effects of ARISTADA INITIO and ARISTADA
include restlessness or feeling like you need to
move (akathisia). These are not all the possible side effects of ARISTADA
INITIO and ARISTADA. You should tell
your healthcare provider about any side-effects you have.
When starting ARISTADA, you may receive a one-time injection called ARISTADA INITIO along with 30 mg of oral aripiprazole. In some cases, your doctor will have you start with 21 days of oral aripiprazole if ARISTADA INITIO is not right for you.
Please watch the additional Important Safety Information contained in this video.
PAM: I really like havin’ ARISTADA as an injection. I like havin’ that option. It’s nice that
Dorian doesn’t have to take a daily pill to treat his schizophrenia. The doctor told us that it’s important that
Dorian stays on track with his shots. He told us that if Dorian missed an injection appointment, we need to
contact him right away. Since receiving ARISTADA, I’ve seen Dorian’s schizophrenia symptoms get better. Keep in
mind, this is Dorian’s experience, and yours may be different. Dorian is still going group. He’s still seeing a
therapist; he’s still seeing his psychiatrist. Sometimes Dorian and I do have group therapy together, only
because I’m a lot! Only because he’s a lot sometimes. So, we do talk through our issues, we talk through our
feelings, and it does help. I think Dorian is enjoying his life. He has hobbies that he keeps up with, and he’s
doing well. I’m really proud of him. The most important thing that I found through this whole journey, is that
I’m way tougher than what I thought. Being a caregiver is not easy. Some days could still be really tough.
Sometimes I could still feel really defeated, but you still move on. I’ve had to make some adjustments in life.
I still find time to go on a trip, whether it’s with Dorian or just by myself—with my friends. You have to make
time for yourself. If you don’t make
time for yourself, you feel like you’re spinning. You have to figure out balance, and don’t be afraid to ask for
help. Talk to your therapist, find that support system—seek help, and you gotta
keep moving on—you can’t stop.
NARRATOR: IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at
increased risk of death when treated with antipsychotic medicines including ARISTADA INITIO and ARISTADA. ARISTADA
INITIO and ARISTADA are not for the treatment of people who have lost touch with reality
(psychosis) due to confusion and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or
ARISTADA if you are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic
reactions to aripiprazole have ranged from rash, hives and itching to anaphylaxis, which may include difficulty
breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects including:
- Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
-
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your
healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the
following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure
- Uncontrolled body movements (tardive dyskinesia). ARISTADA
INITIO and ARISTADA may cause movements that you cannot control in your face, tongue, or other
body parts. Tardive dyskinesia may not go away, even if you stop receiving ARISTADA. Tardive dyskinesia may
also start after you stop receiving ARISTADA.
-
Problems with your metabolism such as:
- High blood sugar (hyperglycemia). Increases in blood sugar can happen in some
people who receive ARISTADA INITIO and/or ARISTADA. Extremely high
blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as
being overweight or a family history of diabetes), your healthcare provider should check your blood
sugar before you receive ARISTADA INITIO and/or ARISTADA and during
your treatment with ARISTADA.
-
-
-
Call your healthcare provider if you have any of these symptoms of high blood
sugar:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
-
- Increased fat levels (cholesterol and triglycerides) in your blood
- Weight gain. You and your healthcare provider should check your weight regularly.
- Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had
strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive
urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that
you are having unusual strong urges, talk to your healthcare provider.
- Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when
you rise too quickly from a sitting or lying position.
- Falls. ARISTADA INITIO and ARISTADA may make you sleepy or
dizzy when standing which may make you at risk for falls and related injuries.
- Low white blood cell count
- Seizures (convulsions)
- Problems controlling your body temperature. Avoid becoming too hot or dehydrated.
Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out
of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
- Difficulty swallowing
The most common side effects of ARISTADA INITIO and
ARISTADA include restlessness or feeling like you need to move (akathisia). These are not all the
possible side effects of ARISTADA INITIO and ARISTADA. You should tell your
healthcare provider about any side-effects you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how
ARISTADA INITIO and ARISTADA affect you. ARISTADA
INITIO and ARISTADA may affect your judgment, thinking or motor skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare
provider about all of your medical conditions, including if you:
- have not taken Abilify®, Abilify Maintena®, or any aripiprazole product before
- have or had heart problems or a stroke
- have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare
provider should check your blood sugar before you receive ARISTADA INITIO
and/or ARISTADA and during your treatment with ARISTADA
- have or had low or high blood pressure
- have or had seizures (convulsions)
- have or had a low white blood cell count
- have problems that may affect you receiving an injection in your buttocks or your arm
- are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO
and/or ARISTADA will harm your unborn baby. If you become pregnant while taking ARISTADA INITIO and/or ARISTADA, talk to your healthcare provider about
registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388, or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
- are breastfeeding or plan to breastfeed. ARISTADA INITIO and/or ARISTADA
can pass into your breast milk. It is not known if it may harm your baby. Talk to your healthcare provider
about the best way to feed your baby if you receive ARISTADA INITIO and/or
ARISTADA.
Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
ARISTADA INITIO and ARISTADA and other medicines may affect each other causing
possible serious side effects. Do not start or stop any medicines after you receive ARISTADA INITIO and ARISTADA without talking to your healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider. You are
encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
JULIAN: Well, participating in a support group once a month has been helpful for me because I
put myself in another person’s shoe just to see what they’re going through. So, when it comes to me, and I talk
about them, then I figure they can do the same, so put themselves in my shoes. To anybody that’s sitting at home
wanting to go to a support group or just wanting to learn about mental health, you should just give it a try.
You can learn a lot.
PAM: As a caregiver I always need support. How can you give support to somebody and not take
care of yourself? I do a lot, uh, I go to support groups. I go to therapy for myself. I also go to the support
groups, maybe once a month when he’s going to his support groups just so I can get that extra of knowing I’m not
alone. The most useful resource that I found after finding out Dorian has schizophrenia was NAMI. NAMI’s
website, their support groups, their whole team when you go down that path is there to make it easier instead of
harder.
PAUL: In the back of my mind, I think there was always something that wasn’t right. When I got
stressed out it was hard for me to think straight. I wouldn’t treat people like they should be treated, that
showed them respect.
PAULETTE: Paul had many tests growing up, because we were always concerned, "Gee, was he not
hearing correctly? Did he have some kind of a visual problem?" If he was given 3 or 4 tasks, he possibly could
only remember 2, so that was very difficult for him. Psychologists said that it was like a missing link in his
head, and it always would be.
PAUL: In high school I saw my friends get ahead of me. It did hurt me because I felt alone in a
way. I started to feel a lotta anger. It was a scary situation. It was very difficult for me.
PAULETTE: I noticed that he was talking to himself quite a bit, carrying on conversations in
a completely empty room. I would just make a joke out of it, so I would walk in and say, "Hey, who we got over
today, Paul? Who we talking to today?” It was such a bang over the head when I found out that he really had been
hearing voices. I honestly didn’t think it was that serious, so I just made light of it thinking it would go
away. The older he got, the more withdrawn he got and then angry. He would get really angry about almost
nothing. His college days were really tough. That’s when it seemed like everything came down on him really
heavy.
PAUL: I felt like I was just spinning my wheels. I wasn’t getting anywhere. The lifestyle and
work was too much for me. I couldn’t get the answers right on tests. I felt like I was a deer in a headlight
most of the time.
PAULETTE: It had gotten to the point where we needed help. Paul had gotten violent. We were
having guests in, I went into the guest room and rearranged all the furniture, and he came in storming at me and
literally threw me up against a wall. When this happened I really didn’t know who Paul was. He didn’t—he didn’t
act like himself. It was not anybody I recognized. I was scared. I was scared of Paul. I was scared to be in the
house. I’d never seen that side—that side of him to become violent.
PAUL: I felt like I had no brain and I didn’t know what I was doing. After that was over, I
looked at my mom and said, "I need help."
PAULETTE: He was very apologetic, very loving, and at that point I knew we had to get help. And
we found a doctor and he said, "I know exactly what’s the matter with Paul,” he said, "because I have a brother
also that has the same disease.” That day he diagnosed Paul with schizophrenia. It really shocked me when I
heard. I knew there was something serious, but you never want to hear that it’s a lifetime illness.
PAUL: He also said there was no cure for what I have. But he reassured me that although I will
always have this, with treatment it can be manageable.
PAULETTE: Paul was at one of his routine appointments when the doctor brought up ARISTADA. He
wanted to know if Paul would be interested in trying a treatment that he could receive via injection. So the
doctor knew that Paul had established a tolerability for aripiprazole from the previous oral medications that he
had been taking. After learning more about it and discussing the risks and benefits with his doctor, they
determined it was the right treatment for him.
NARRATOR: ARISTADA INITIO®
(aripiprazole lauroxil) and
ARISTADA® (aripiprazole lauroxil) may not be right for everyone.
INDICATION
ARISTADA INITIO is a prescription medicine given as a one-time
injection and is used in combination with oral aripiprazole to start ARISTADA treatment, or re-start ARISTADA treatment after a missed dose, when ARISTADA is used for the
treatment of schizophrenia in adults.
ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat
schizophrenia in adults.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in
children under 18 years of age.
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Before you start treatment with ARISTADA INITIO and ARISTADA, tell your
healthcare provider if you have ever taken Abilify®, Abilify Maintena®, or any aripiprazole product before. People who are allergic to
aripiprazole or any of the ingredients in ARISTADA should not receive ARISTADA. People must first tolerate oral
aripiprazole before receiving ARISTADA INITIO or ARISTADA.
The most common side effects of ARISTADA INITIO and ARISTADA include
restlessness or feeling like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and ARISTADA. You should tell your healthcare provider about any
side-effects you have.
When starting ARISTADA, you may receive a one-time injection called ARISTADA INITIO along with 30 mg of oral
aripiprazole. In some cases, your doctor will have you start with 21 days of oral aripiprazole if ARISTADA INITIO is not right for you.
Please watch the additional Important Safety Information contained in this video.
PAUL: I first started ARISTADA with monthly injections. And then my doctor told me there is
also an option to receive it every 2 months, so I switched to that dose. Now I go in every 2 months to receive
an injection. It works great for me. I like that I don’t have to think about it every day. The doctor stressed
the importance of following the prescription schedule to keep steady medication levels in my body. If I did miss
a treatment session, I need to contact my doctor right away. Since being on treatment with ARISTADA, I’ve
experienced an improvement in my schizophrenia symptoms. Remember though, this is my experience on ARISTADA and
your experience may be different.
PAULETTE: My role as a caregiver has definitely changed since the beginning. I was very
protective of him earlier on. But then as we found a good doctor and he got married, I have been able to step
back. I also like to see how Paul works hard at his jobs, which he likes.
PAUL: For anyone who has been diagnosed with schizophrenia, I’d tell them to hang in there,
listen to your doctor. I know I will always work with my health care team to keep a treatment plan. I do feel
thankful for my family. They’ve encouraged me and they give me strength. I am thankful for my mom. She’s been a
wonderful caregiver throughout my whole life.
NARRATOR: IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or ARISTADA if you
are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole
have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in
the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects
including:
- Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
-
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your
healthcare provider or go to the nearest hospital emergency room right away if you have some or all
of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure
-
Uncontrolled body movements (tardive dyskinesia). ARISTADA
INITIO and ARISTADA may cause movements that
you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even
if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
-
Problems with your metabolism such as:
-
High blood sugar (hyperglycemia). Increases in blood sugar can happen in some
people who receive ARISTADA INITIO and/or ARISTADA. Extremely high
blood sugar can lead to coma
or death. If you have diabetes or risk factors for diabetes (such as being overweight or a
family history of diabetes), your healthcare provider should check your blood sugar before you
receive ARISTADA INITIO and/or ARISTADA and during your treatment
with ARISTADA.
-
-
-
Call your healthcare provider if you have any of these symptoms of high
blood sugar:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
-
- Increased fat levels (cholesterol and triglycerides) in your blood
-
Weight gain. You and your healthcare provider should check your weight
regularly.
-
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had
strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive
urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice
that you are having unusual strong urges, talk to your healthcare provider.
-
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint
when you rise too quickly from a sitting or lying position.
-
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or
dizzy when standing which
may make you at risk for falls and related injuries.
- Low white blood cell count
- Seizures (convulsions)
-
Problems controlling your body temperature. Avoid becoming too hot or dehydrated.
Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay
out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
- Difficulty swallowing
The most common side effects of ARISTADA INITIO and ARISTADA
include restlessness or feeling
like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and
ARISTADA. You should tell your healthcare provider about any side-effects
you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA INITIO and ARISTADA affect you. ARISTADA
INITIO and ARISTADA may affect your judgment, thinking or motor skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider
about all of your medical
conditions, including if you:
-
have not taken Abilify®, Abilify Maintena®, or any aripiprazole
product before
- have or had heart problems or a stroke
-
have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare
provider should check your blood sugar before you receive ARISTADA INITIO
and/or ARISTADA and during
your treatment with ARISTADA
- have or had low or high blood pressure
- have or had seizures (convulsions)
- have or had a low white blood cell count
- have problems that may affect you receiving an injection in your buttocks or your arm
-
are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO
and/or ARISTADA will harm
your unborn baby. If you become pregnant while taking ARISTADA INITIO
and/or ARISTADA, talk to your
healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.
You can register by calling 1-866-961-2388, or
visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
-
are breastfeeding or plan to breastfeed. ARISTADA INITIO and/or ARISTADA
can pass into your breast milk.
It is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed
your baby if you receive ARISTADA INITIO and/or ARISTADA.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO and ARISTADA and other
medicines may affect each other causing possible serious side effects. Do not start or stop any medicines
after you receive ARISTADA INITIO and ARISTADA without talking to your
healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider. You are
encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
CAROLYNE: I had a really rough childhood. I was adopted. I never knew my real parents. It was
very abusive. There was no one there for me. I thought that no one would love me and care for me. I was so
innocent and vulnerable and helpless. I had to take care of myself. When I was a teenager, I got myself a
housekeeping job; I worked to get my GED, and then I went to school to become a nursing assistant. After I
graduated, I became a home healthcare nursing aide. I was very happy doing my job. I love taking care of sick
people. You know, just being able to give back what I never had. I was in my late twenties when I noticed
something was wrong with me. I was very depressed; I was crying; I was experiencing paranoia, hallucinations—hearing
voices. And then I would see shadows and feel like someone was tapping me on the shoulder. Something
just wasn’t feeling right. So, I thought, maybe I was dying—maybe there was something physically wrong. So, I
went to the hospital. The doctor ran some tests. He told me I wasn’t sick physically. He thought something was
wrong with me mentally. I saw a psychiatrist in the hospital for a few weeks, and after meeting with him several
times and discussing the symptoms I was experiencing, he diagnosed me with schizophrenia. I was dumbfounded. I
was scared. I was afraid. I didn’t even know what the word meant. I thought it happened to me because of my
childhood and the traumatic past that I went through in my life as a younger person. The doctor told me that
schizophrenia is a mental disorder. And he said I might see things, hear things, and also have delusional
thoughts. I started doing some research on schizophrenia because I wanted to know what that meant for me in the
future. It scared me. It really scared me, because it was like, “Oh my God. This has happened to me. I have no
family. I have no friend. I have no one to lean on. What am I supposed to do?” From that point, I was in
and out
of the hospital, before I was able to be on my own. I tried a couple of different treatments. They helped, but
my symptoms continued. I found out about ARISTADA through my psychiatrist. He thought it might help me with my
symptoms. He told me ARISTADA is an injection that I would get at his office. He told me about the benefits and
the potential side effects, and I decided to try it.
NARRATOR: ARISTADA INITIO®
(aripiprazole lauroxil) and
ARISTADA® (aripiprazole lauroxil) may not be right for everyone.
ARISTADA INITIO is a prescription medicine given as a one-time
injection and is used in combination with oral aripiprazole to start ARISTADA treatment, or re-start ARISTADA treatment after a missed dose, when ARISTADA is used for the
treatment of schizophrenia in adults.
ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat
schizophrenia in adults.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in
children under 18 years of age.
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Before you start treatment with ARISTADA INITIO and ARISTADA, tell your
healthcare provider if you have ever taken Abilify®, Abilify Maintena®, or any aripiprazole product before. People who are allergic to
aripiprazole or any of the ingredients in ARISTADA should not receive ARISTADA. People must first tolerate oral
aripiprazole before receiving ARISTADA INITIO or ARISTADA.
The most common side effects of ARISTADA INITIO and ARISTADA include
restlessness or feeling like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and ARISTADA. You should tell your healthcare provider about any
side-effects you have.
When starting ARISTADA, you may receive a one-time injection called ARISTADA INITIO along with 30 mg of oral
aripiprazole. In some cases, your doctor will have you start with 21 days of oral aripiprazole if ARISTADA INITIO is not right for you.
Please watch the additional Important Safety Information contained in this video.
CAROLYNE: My schizophrenia symptoms have gotten better since I’ve been on ARISTADA. This has
just been my experience on ARISTADA. Yours may be different. I like that ARISTADA is an injection. It’s nice
that I don’t have to remember to take pills every day. I am continuing to see a psychiatrist and a therapist.
I’m no longer working, and I try to keep myself productive and busy. During my day, I try to keep the house
clean; I cook for my husband when he comes home from work, I really love reading, listening to music, and I go
for walks—I go the store. I met Anthony through a friend. The first time I saw Anthony, I’m like, “Oh my God!
Who is that guy?” It was love at first sight! Anthony knew about my condition when we first met, and it didn’t
scare him away. Anthony has been wonderful in my life. Whenever I get anxious or nervous, he kisses me on my
cheek and tells me, “Somebody loves you. You’re going to be okay.” And believe me, that’s the best thing. It
helps a lot. I never thought I would find love. I thought I didn’t deserve love. Anthony was the very first man
I have learned to trust. He’s been my rock. The best advice I can give to someone living with schizophrenia is
to not be ashamed. Do not think that no one is going to believe you, or no one will want to help you. Try
talking to your loved ones. Try to get them educated about what’s happening to you. It’s important to not live
in fear. Find a way to love yourself and deal with your schizophrenia. Seek professional help. Always give life
a second chance. Don’t give up on it. I’m proof of that.
NARRATOR: IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or ARISTADA if you
are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole
have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in
the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects
including:
- Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
-
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your
healthcare provider or go to the nearest hospital emergency room right away if you have some or all
of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure
-
Uncontrolled body movements (tardive dyskinesia). ARISTADA
INITIO and ARISTADA may cause movements that
you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even
if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
-
Problems with your metabolism such as:
-
High blood sugar (hyperglycemia). Increases in blood sugar can happen in some
people who receive ARISTADA INITIO and/or ARISTADA. Extremely high
blood sugar can lead to coma
or death. If you have diabetes or risk factors for diabetes (such as being overweight or a
family history of diabetes), your healthcare provider should check your blood sugar before you
receive ARISTADA INITIO and/or ARISTADA and during your treatment
with ARISTADA.
-
-
-
Call your healthcare provider if you have any of these symptoms of high
blood sugar:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
-
- Increased fat levels (cholesterol and triglycerides) in your blood
-
Weight gain. You and your healthcare provider should check your weight
regularly.
-
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had
strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive
urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice
that you are having unusual strong urges, talk to your healthcare provider.
-
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint
when you rise too quickly from a sitting or lying position.
-
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or
dizzy when standing which
may make you at risk for falls and related injuries.
- Low white blood cell count
- Seizures (convulsions)
-
Problems controlling your body temperature. Avoid becoming too hot or dehydrated.
Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay
out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
- Difficulty swallowing
The most common side effects of ARISTADA INITIO and ARISTADA
include restlessness or feeling
like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and
ARISTADA. You should tell your healthcare provider about any side-effects
you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA INITIO and ARISTADA affect you. ARISTADA
INITIO and ARISTADA may affect your judgment, thinking or motor skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider
about all of your medical
conditions, including if you:
-
have not taken Abilify®, Abilify Maintena®, or any aripiprazole
product before
- have or had heart problems or a stroke
-
have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare
provider should check your blood sugar before you receive ARISTADA INITIO
and/or ARISTADA and during
your treatment with ARISTADA
- have or had low or high blood pressure
- have or had seizures (convulsions)
- have or had a low white blood cell count
- have problems that may affect you receiving an injection in your buttocks or your arm
-
are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO
and/or ARISTADA will harm
your unborn baby. If you become pregnant while taking ARISTADA INITIO
and/or ARISTADA, talk to your
healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.
You can register by calling 1-866-961-2388, or
visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
-
are breastfeeding or plan to breastfeed. ARISTADA INITIO and/or ARISTADA
can pass into your breast milk.
It is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed
your baby if you receive ARISTADA INITIO and/or ARISTADA.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO and ARISTADA and other
medicines may affect each other causing possible serious side effects. Do not start or stop any medicines
after you receive ARISTADA INITIO and ARISTADA without talking to your
healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider. You are
encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
PAM: The most important person of our healthcare team most definitely is our psychiatrist and
his team. They listen. For me being a caregiver, and with Dorian not always being able to advocate on his behalf
in a sentence from start to finish what he needs, they always take that into consideration. I play a role in
Dorian’s care with his doctors and just his overall wellbeing. You have to have—ask questions. There’s no thing
as too many questions. There’s no thing as a wrong question. If you don’t know, ask. If you have a good doctor
team, they don’t have a problem answering those questions for you. So, you are going to constantly have to
communicate with the healthcare team to move forward.
CHRISTY: My advice for other caregivers is find the right team, interview them, keep moving
forward, and never give up. And they’re worth it and, you know, you’re worth it, you know, and there is help.
It’s hard to find, but you can find it and- and- and get it done. Just make sure that you have a list of
questions. Whatever concerns that you have for your loved one, write them down.
KELSEY: Some advice I would have for somebody who’s struggling with, you know, meeting new
people and having the confidence would be to, you know, just try to put yourself out there maybe. Confidence to
me is important because, you know, we’re all unique in each other—in our own different way. And you just gotta
embrace your own confidence, your own beauty.
JULIAN: Well, because it’s important to interact with other people just so you can get a
feeling of that you’re not the only one that’s going through something. You’re not the only one that has a
problem or issue. There’s other people out there even if they don’t have schizophrenia, they still have their
own problems and their own—their own battles. Ah, that feeling that we’re not alone is important because we are
humans; we crave other people. We- we crave acceptance and stuff like that.
NARRATOR: Living with schizophrenia can present daily challenges, but finding treatment shouldn’t be
one of them. If
you or someone you know has been diagnosed with schizophrenia ARISTADA INITIO
and ARISTADA may be able to help.
Please see full Prescribing Information, including Boxed Warning, and Medication Guides for ARISTADA INITIO and
ARISTADA. Please see additional Important Safety Information within this video.
ARISTADA® (aripiprazole lauroxil) is a prescription medicine given by injection by a healthcare professional and
used to treat schizophrenia in adults.
ARISTADA INITIO® (aripiprazole lauroxil) is a prescription medicine given as a one-time injection and is used in
combination with oral aripiprazole to start ARISTADA for the treatment of schizophrenia in adults. ARISTADA INITIO can also be used to re-start ARISTADA after a dose is missed.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in
children under 18 years of age.
ARISTADA is a treatment you may have the option to get every 2 months if you and your doctor decide it’s right
for you.
Elderly people with dementia-related psychosis are at increased risk of death
when treated with antipsychotic
medicines, including ARISTADA INITIO and ARISTADA. ARISTADA INITIO and ARISTADA
are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Please see
additional Important Safety Information within this video.
If you have been diagnosed with schizophrenia, you are not alone.
Schizophrenia affects 1.1% of the US population and the exact cause is unknown.
There are many factors that may play a role in the development of schizophrenia.
Experts believe it could be a combination of things, including family history, environment, and chemical
imbalances in the brain.
People can have different symptoms that may interfere with daily life such as hallucinations, which means seeing
or hearing things that are not there.
The types of symptoms someone has and how severe they are may change over time.
Just as there are different symptoms there are different ways to receive the medicine you need for
schizophrenia.
Medicine for schizophrenia can be taken by mouth or given by injection.
Both options can provide the medicine you need; the difference is how you take them and how often.
With an oral medicine, you must take a pill every day.
ARISTADA is a long-acting treatment designed to release medicine slowly in your
body allowing 1
dose to last for
1 month, for 6 weeks, or for 2 months, depending on the dose you and your doctor decide is right for you.
In a clinical study, ARISTADA showed an improvement in symptoms of schizophrenia.
Before starting ARISTADA, your doctor will want to make sure you are not allergic to aripiprazole.
Tell your healthcare provider if you have not taken Abilify®, Abilify
Maintena®, or any aripiprazole product
before. You should also tell your healthcare provider about all of your medical conditions before starting
ARISTADA. Please see Important Safety Information within this video and the ARISTADA Medication Guide for more
information.
People who are allergic to aripiprazole or any of the ingredients in ARISTADA should not receive ARISTADA or
ARISTADA INITIO. You may have to take oral aripiprazole for a short period of
time to see if your body can
tolerate it before starting treatment with ARISTADA INITIO or ARISTADA.
Once your doctor knows that you can tolerate oral aripiprazole, you and your doctor can discuss what dose of
ARISTADA may be right for you.
When beginning ARISTADA treatment, your doctor may start with ARISTADA INITIO.
On your first day, you’ll receive
a single 30 mg dose of oral aripiprazole, a one-time injection of ARISTADA INITIO, and your
first injection of
ARISTADA.
Injections are given by your healthcare provider into the muscle of your arm or buttock.
All 3 steps can happen on your first treatment day, or you can get ARISTADA up to 10 days later.
There are 2 ways to start treatment with ARISTADA. In some cases, you and your doctor may decide to start your first ARISTADA injection with 21 days of oral
aripiprazole if your doctor determines ARISTADA INITIO is not right for you.
However, you begin your treatment
with ARISTADA, you have one less medicine to take each day after completing your starting doses as directed by
your doctor.
You should not miss a dose of ARISTADA. If you miss a dose for some reason, call your healthcare provider right
away to discuss what you should do next.
You should also talk to your healthcare provider about dosing, injection-site
options, and how often you will
receive ARISTADA.
The most common side effect seen with ARISTADA INITIO and ARISTADA is
restlessness or feeling like you need to
move, a condition called akathisia.
Other side effects are possible, some of them serious. Tell your doctor about any changes or side effects you
have while taking ARISTADA.
Every person responds to schizophrenia medicine differently. Work with your healthcare team to make a treatment
plan and ask your doctor if moving forward with ARISTADA and receiving your treatment every 2 months with
ARISTADA 1064 may be right for you.
Please listen to the following Important Safety Information for ARISTADA INITIO
and ARISTADA.
INDICATION
ARISTADA INITIO® (aripiprazole lauroxil) is a prescription medicine given as a one-time
injection and is used in combination with oral aripiprazole to start ARISTADA® (aripiprazole lauroxil) treatment, or re-start ARISTADA treatment after a missed dose, when ARISTADA is used for the
treatment of schizophrenia in adults.
ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat
schizophrenia in adults.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in
children under 18 years of age.
IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at increased risk of
death when treated with antipsychotic medicines including ARISTADA INITIO
and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of
people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or ARISTADA if you
are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole
have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in
the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects
including:
- Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
-
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your
healthcare provider or go to the nearest hospital emergency room right away if you have some or all
of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure
-
Uncontrolled body movements (tardive dyskinesia). ARISTADA
INITIO and ARISTADA may cause movements that
you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even
if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
-
Problems with your metabolism such as:
-
High blood sugar (hyperglycemia). Increases in blood sugar can happen in some
people who receive ARISTADA INITIO and/or ARISTADA. Extremely high
blood sugar can lead to coma
or death. If you have diabetes or risk factors for diabetes (such as being overweight or a
family history of diabetes), your healthcare provider should check your blood sugar before you
receive ARISTADA INITIO and/or ARISTADA and during your treatment
with ARISTADA.
-
-
-
Call your healthcare provider if you have any of these symptoms of high
blood sugar:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
-
- Increased fat levels (cholesterol and triglycerides) in your blood
-
Weight gain. You and your healthcare provider should check your weight
regularly.
-
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had
strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive
urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice
that you are having unusual strong urges, talk to your healthcare provider.
-
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint
when you rise too quickly from a sitting or lying position.
-
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or
dizzy when standing which
may make you at risk for falls and related injuries.
- Low white blood cell count
- Seizures (convulsions)
-
Problems controlling your body temperature. Avoid becoming too hot or dehydrated.
Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay
out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
- Difficulty swallowing
The most common side effects of ARISTADA INITIO and ARISTADA
include restlessness or feeling
like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and
ARISTADA. You should tell your healthcare provider about any side-effects
you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA INITIO and ARISTADA affect you. ARISTADA
INITIO and ARISTADA may affect your judgment, thinking or motor skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider
about all of your medical
conditions, including if you:
-
have not taken Abilify®, Abilify Maintena®, or any aripiprazole
product before
- have or had heart problems or a stroke
-
have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare
provider should check your blood sugar before you receive ARISTADA INITIO
and/or ARISTADA and during
your treatment with ARISTADA
- have or had low or high blood pressure
- have or had seizures (convulsions)
- have or had a low white blood cell count
- have problems that may affect you receiving an injection in your buttocks or your arm
-
are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO
and/or ARISTADA will harm
your unborn baby. If you become pregnant while taking ARISTADA INITIO
and/or ARISTADA, talk to your
healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.
You can register by calling 1-866-961-2388, or
visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
-
are breastfeeding or plan to breastfeed. ARISTADA INITIO and/or ARISTADA
can pass into your breast milk.
It is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed
your baby if you receive ARISTADA INITIO and/or ARISTADA.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO and ARISTADA and other
medicines may affect each other causing possible serious side effects. Do not start or stop any medicines
after you receive ARISTADA INITIO and ARISTADA without talking to your
healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider. You are
encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
