INVEGA® SUSTENNA® (paliperidone palmitate) Information

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About Schizophrenia

About INVEGA^® SUSTENNA^®

Important Safety Information for INVEGA^® SUSTENNA^®

Starting INVEGA^® SUSTENNA^®

Patient Assistance

About Schizophrenia

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What is schizophrenia?

Schizophrenia is believed to be caused when certain chemicals in the brain are not in balance. Not all people with schizophrenia have the same symptoms. Some of the most common symptoms of schizophrenia may include:

Seeing, hearing, or sensing things that are not there (hallucinations)
Believing that what other people say is not true (delusions)
Not trusting others and feeling very suspicious (paranoia)
Avoiding family and friends and wanting to be alone

About INVEGA® SUSTENNA®

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Is INVEGA® SUSTENNA® right for me?

Talk to your doctor. Only your doctor can decide whether INVEGA® SUSTENNA® is right for you.

What is INVEGA® SUSTENNA®?

INVEGA® SUSTENNA® is a type of prescription medication called an atypical antipsychotic. It is given as an injection by your doctor or another healthcare professional.

INVEGA® SUSTENNA® is used to treat the symptoms of schizophrenia.

INVEGA® SUSTENNA® can be used to lessen the chance of your schizophrenia symptoms coming back.

How does INVEGA® SUSTENNA® work?

The exact way INVEGA® SUSTENNA® works is not known. INVEGA® SUSTENNA® is thought to help restore the balance of certain chemicals in the brain. It has been shown to help many people manage their symptoms of schizophrenia. It may take some time before your symptoms of schizophrenia start to improve. Remember that INVEGA® SUSTENNA® is one part of your overall treatment plan. It is important to keep all your appointments so you can get your treatments on time and your treatment team can check your progress.

How often is INVEGA® SUSTENNA® given?

INVEGA® SUSTENNA® is a long-acting medication that your doctor or another healthcare professional will give you by injection. This means that you do not have to take this medication every day. When you receive your first dose of INVEGA® SUSTENNA®, you will need to get a second dose one week later. After that you will only need to get a dose once a month.

What if I miss a dose of INVEGA® SUSTENNA®?

It is very important to keep all your appointments and get your injections on time. If you think you are going to miss your appointment, call your doctor or treatment team as soon as you can. Your doctor or treatment team will decide what you should do next.

If you miss getting your dose of INVEGA® SUSTENNA®, call your doctor or treatment team right away to schedule an appointment.

How will my treatment team give INVEGA® SUSTENNA®?

Your doctor or another healthcare professional will give you an injection into the upper arm or buttocks.

What if I stop receiving INVEGA® SUSTENNA®?

If you stop coming for your injections, your symptoms may return. You should not stop receiving injections of this medicine unless you have discussed this with your doctor.

How can I get the most benefit from my INVEGA® SUSTENNA® treatment?

Remember to keep all your appointments. You need to receive your INVEGA® SUSTENNA® treatments on time and your treatment team needs to check your progress. If you are going to miss an appointment, call your doctor's office right away so you can get your next dose as soon as possible.

Keep a list of questions. Discuss this list with your treatment team at your next visit. Your treatment team wants to know how the medicine is working so they can give you the best care possible.

Be patient. It may take some time before your symptoms of schizophrenia start to improve.

Follow the plan developed by you and your treatment team. Remember that INVEGA® SUSTENNA® is one part of your overall treatment plan.

Why do I have to get 2 doses when I start INVEGA® SUSTENNA®?

Once you receive your first dose of INVEGA® SUSTENNA®, you will need to get a second dose one week later to help get enough medicine in your system quickly. After that, your doses will be given regularly once a month.

What is the dose range for INVEGA® SUSTENNA®?

INVEGA® SUSTENNA® is available in a range of doses from 39 mg to 234 mg. Remember, all medicines are dosed differently and only your doctor can determine which dose is right for you.

What is INVEGA® SUSTENNA® used for?

INVEGA® SUSTENNA® is used to treat symptoms of schizophrenia in adults 18 years of age or older. INVEGA® SUSTENNA® can also be used to lessen the chance of your schizophrenia symptoms coming back.

Is INVEGA® SUSTENNA® approved for use in children and adolescents with schizophrenia?

INVEGA® SUSTENNA® is used to treat symptoms of schizophrenia in adults 18 years of age or older. INVEGA® SUSTENNA® is not approved for use in people that are less than 18 years old.

Can INVEGA® SUSTENNA® be used for acute agitation?

No, INVEGA® SUSTENNA® is not for acute agitation because it is a long-acting medicine, not a short acting medicine. INVEGA® SUSTENNA® can be used for the acute and maintenance treatment of schizophrenia.

Important Safety Information for INVEGA® SUSTENNA®

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What is the most important safety information I need to know about INVEGA® SUSTENNA®?

INVEGA® SUSTENNA® is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA® SUSTENNA® in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.

Who should not use INVEGA® SUSTENNA®?

INVEGA® SUSTENNA® is not approved for the treatment of elderly patients who have a diagnosis of psychosis related to dementia.

What should I tell my doctor before starting INVEGA® SUSTENNA®?

Only your doctor can decide if INVEGA® SUSTENNA® is right for you. Before you start INVEGA® SUSTENNA®, be sure to tell your doctor or treatment team if you:

Have a history of heart problems, any problems with the way your heart beats, or are being treated for high blood pressure
Have diabetes or a family history of diabetes
Have a history of low white blood cell counts
Have low levels of potassium or magnesium in your blood
Are being treated for seizures (fits or convulsions), have had seizures in the past, or have conditions that increase the risk of having seizures
Have kidney or liver problems
Have ever had any conditions that cause dizziness or fainting
Are pregnant or plan to become pregnant during treatment
Are breast-feeding. Women should not breast-feed a baby during treatment
Are taking or plan to take any prescription medicines or over-the-counter medicines such as vitamins, herbal products, or dietary supplements. Your healthcare professional will let you know if there are any concerns with taking INVEGA® SUSTENNA® with your other medications

What are the possible side effects of INVEGA® SUSTENNA®?

As with any medicine, INVEGA® SUSTENNA® may cause side effects in some people. If you think you are developing a side effect, always discuss this with your doctor or treatment team.

Common side effects of INVEGA® SUSTENNA® include:

Reactions at the injection site
Sleepiness
Dizziness
Feeling of inner restlessness
Abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes

What happens if I start to experience a side effect on INVEGA® SUSTENNA®?

If you think you are developing a side effect, always discuss this with your doctor or treatment team.

Will INVEGA® SUSTENNA® make me gain weight?

It is important to know that significant weight gain has been reported with the use of INVEGA® SUSTENNA® and other medications like INVEGA® SUSTENNA® that treat the symptoms of schizophrenia. Speak to your healthcare professional if weight gain is a concern. If you are currently taking INVEGA® SUSTENNA®, and notice that you are gaining weight, please talk to your doctor.

Can I take INVEGA® SUSTENNA® if I am nursing, pregnant, or planning to get pregnant?

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with INVEGA® SUSTENNA®. Women should not breast-feed a baby during treatment.

Will INVEGA® SUSTENNA® make me feel sleepy or tired?

INVEGA® SUSTENNA® can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA® SUSTENNA®, be careful driving a car, operating machines, or doing things that require you to be alert.

Do people usually feel any pain from the injection?

People usually feel some pain or discomfort after receiving an injection of INVEGA® SUSTENNA®. In clinical studies, most patients reported the injections became less painful over time.

Is there anything I should avoid doing while taking INVEGA® SUSTENNA®?

This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.

Do not drink alcohol while you are taking INVEGA® SUSTENNA®.

Starting INVEGA® SUSTENNA®

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Once my doctor decides that INVEGA® SUSTENNA® is right for me, how will I begin treatment?

Your doctor may give you an oral test dose of a medication to determine if you will be able to take INVEGA® SUSTENNA®. Your doctor will then determine the right dose of INVEGA® SUSTENNA®.

What is the difference between INVEGA® SUSTENNA® (paliperidone palmitate) and RISPERDAL® CONSTA® (risperidone)?

INVEGA® SUSTENNA® and RISPERDAL® CONSTA® are different long-acting medications. Talk to your doctor for more information about them and visit RisperdalConsta.com.

Patient Assistance

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What kind of patient assistance program is available to support INVEGA® SUSTENNA®?

Janssen®, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is committed to helping patients get the prescription medications they need. INVEGA® SUSTENNA® is available through the Janssen® Access2wellness Program. If you have any questions about the program or application process, please visit www.access2wellness.com for more information.

Where can I find more information about INVEGA® SUSTENNA®?

If you have any questions about INVEGA® SUSTENNA®, talk with your doctor or treatment team.

You can also visit the website at www.invegasustenna.com or call the toll-free number at 1-800-JANSSEN (1-800-526-7736) for more information about INVEGA® SUSTENNA®.

IMPORTANT SAFETY INFORMATION FOR INVEGA® SUSTENNA®

INVEGA® SUSTENNA® (paliperidone palmitate) is used for the treatment of schizophrenia.

Neuroleptic Malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEGA® SUSTENNA® and similar medicines. Call the doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.

Tardive Dyskinesia (TD) is a rare, but serious and sometimes permanent side effect reported with INVEGA® SUSTENNA® and similar medicines. Call your doctor right away if you start to develop twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the total dose received. This condition can also develop after a short period of treatment at low doses but this is less common. There is no known treatment for TD but it may go away partially or completely if the medicine is stopped.

One risk of INVEGA® SUSTENNA® is that it may change your heart rhythm. This effect is potentially serious. You should talk to your doctor about any current or past heart problems. Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).

High blood sugar and diabetes have been reported with INVEGA® SUSTENNA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or "pass urine" more often than usual, or feeling weak or hungry.

Weight gain has been observed with INVEGA® SUSTENNA® and other atypical antipsychotic medications. If you notice that you are gaining weight, please notify your doctor.

Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly. It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the medicine.

INVEGA® SUSTENNA® and similar medicines have been associated with decreases in the counts of white cells in circulating blood. If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.

INVEGA® SUSTENNA® and similar medicines can raise the blood levels of a hormone called prolactin and blood levels of prolactin remain high with continued use. This may result in some side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.

If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.

This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.

Some medications interact with INVEGA® SUSTENNA®. Please inform your healthcare professional of any medications or supplements that you are taking.

INVEGA® SUSTENNA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with INVEGA® SUSTENNA®.

Do not drink alcohol while you are taking INVEGA® SUSTENNA®.

In a study of people taking INVEGA® SUSTENNA®, common side effects in the treatment of schizophrenia were reactions at the injection site, sleepiness, dizziness, feeling of inner restlessness, and abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes.

This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.

If you have any questions about INVEGA® SUSTENNA® or your therapy, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information.

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RISPERDAL® CONSTA® (risperidone) is used for the treatment of schizophrenia and for the longer-term treatment of Bipolar I Disorder.

IMPORTANT SAFETY INFORMATION FOR RISPERDAL® CONSTA®

Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® CONSTA® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL® CONSTA® and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL® CONSTA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

High blood sugar and diabetes have been reported with RISPERDAL® CONSTA® and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with RISPERDAL® CONSTA®. Complications of diabetes can be serious and even life-threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.

RISPERDAL® CONSTA® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.

Some people taking RISPERDAL® CONSTA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect can be reduced or it may go away over time.

Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your doctor may choose to test your blood as you start therapy with RISPERDAL® CONSTA®.

RISPERDAL® CONSTA® may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

RISPERDAL® CONSTA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Painful, long-lasting erections have been reported with the use of RISPERDAL® CONSTA® . Call your doctor immediately if you think you are having this problem.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL® CONSTA® . Caution should be used when administering RISPERDAL® CONSTA® to a nursing woman.

RISPERDAL® CONSTA® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

Some medications interact with RISPERDAL® CONSTA® . Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDAL® CONSTA®.

In a study of people taking RISPERDAL® CONSTA® , the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.

In a study of people taking RISPERDAL® CONSTA® , the most common side effects in the treatment of bipolar disorder were weight gain (when used alone) and tremors (when used with lithium or valproate).

If you have any questions about RISPERDAL® CONSTA® or your therapy, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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