INVEGA® SUSTENNA® Questions & Answers

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About Schizophrenia

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What is schizophrenia?

Schizophrenia is a complex brain disorder. It can affect a person’s ability to think clearly, manage feelings, make decisions, and relate to others. Schizophrenia is a lifelong illness. Research suggests schizophrenia may be caused by too many or too few of some of the chemicals in the brain. These chemicals are thought to control emotions, motivation, movement, and how people experience the world around them. A problem with these chemicals may cause messages in the brain to get mixed up and bring about symptoms.


It is important to remember that no one causes schizophrenia. No one asks for this disease. It is not the fault of the person with schizophrenia, and it is not the fault of that person’s friends or family. While some research suggests that schizophrenia is caused by a combination of genetic factors or inherited genes that are linked to schizophrenia, it may also be linked to environmental factors. Scientists still do not know the cause. There is no cure yet; however, the symptoms of schizophrenia can be managed with psychiatric care, medicine, and support.

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What are the symptoms of schizophrenia?

Schizophrenia affects people differently. Some experience many symptoms, while others experience just a few. Generally, a doctor will diagnose a person with schizophrenia when 2 or more symptoms occur within a 1-month period and last at least 6 months. Men diagnosed with schizophrenia usually start to show symptoms between their late teen years and early 20s, while women usually develop symptoms during their mid-20s to early 30s. These symptoms are typically separated into 2 categories:

  • Positive symptoms—extra feelings or behaviors that are usually not present, such as distortions in thought content (delusions); hearing, seeing, tasting, feeling, or smelling things that others do not experience (hallucinations); and disorganized speech and behavior
  • Negative symptoms—a lack of behaviors or feelings that usually are present, such as losing interest in everyday activities, like bathing, grooming, or getting dressed; feeling out of touch with other people, family, or friends; lack of feeling or emotion (apathy); having little emotion or inappropriate feelings in certain situations; having less ability to experience pleasure

A number of famous people who are living with schizophrenia have achieved their goals while living with the illness. These include a Nobel Prize winner, a Broadway star, a writer, and a jazz composer.

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.

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Who should not take INVEGA® SUSTENNA®?

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

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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

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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

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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.

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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.

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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.

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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.

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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.

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

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. 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 a test dose of a medication by mouth to determine if you will be able to take INVEGA® SUSTENNA®. Your doctor will then determine the right dose of INVEGA® SUSTENNA®.

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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 Pharmaceuticals, Inc. is committed to helping patients get the prescription medications they need. INVEGA® SUSTENNA® will be 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.

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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 call the toll-free number at 1-800-JANSSEN (1-800-526-7736) for more information about INVEGA® SUSTENNA®.

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

IMPORTANT SAFETY INFORMATION FOR 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.

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 your 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).

Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:

  • 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.
  • Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your doctor while on treatment.
  • Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment.

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.

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.

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 Important Product 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.

Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:

  • High blood sugar and diabetes have been reported with RISPERDAL® CONSTA® 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.
  • Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your doctor while on treatment.
  • Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment. For adolescent patients (12-17 years of age) weight gain should be assessed against that expected with normal growth.

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 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.

For more information about RISPERDAL® CONSTA®, please read the Important Product Information.

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