Please discuss your symptoms with your healthcare professional. Your healthcare professional will review your symptoms and may consult the established guidelines, which are available in the Diagnostic and Statistical Manual of Mental Disorders, where applicable.

INDICATIONS

INVEGA^® (paliperidone) is used for the short-term treatment of schizoaffective disorder in adults and for the treatment of schizophrenia in adults.

INVEGA^® (paliperidone) extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressant therapy in adults. The efficacy of INVEGA^® in schizoaffective disorder was established in two 6-week trials in adults.

INVEGA^® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). INVEGA^® is not for treating dementia-related psychosis.

Do not receive INVEGA^® if you are allergic to paliperidone, risperidone, or any of the ingredients in INVEGA^®.

Cerebrovascular problems (stroke) that can lead to death have been reported in elderly patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare but very serious problem that can happen in people who receive INVEGA^®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever, severe muscle stiffness, confusion, loss of consciousness, or changes in your breathing, heartbeat and blood pressure.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with INVEGA^® 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. Symptoms may go away partially or completely if therapy is stopped.

One risk of INVEGA^® is that it may change your heart rhythm. This effect is potentially serious. You should talk to your healthcare professional about any current or past heart problems. Because these problems could mean you’re having a heart rhythm abnormality, contact your healthcare professional 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^® 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 healthcare professional 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 healthcare professional 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.

INVEGA^® 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.

People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach, or small or large intestine) should talk to their healthcare professional before taking INVEGA^®.

Some people taking INVEGA^® 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 may be reduced.

Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare provider for the potential risk of falls.

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

INVEGA^® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA^® affects you.

INVEGA^® 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.

INVEGA^® may increase difficulty in swallowing that may cause food or liquid to get into your lungs.

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

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.

INVEGA^® should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.

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

Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if INVEGA^® will harm your unborn baby. If you become pregnant while taking INVEGA^®, talk to your healthcare professional 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 Infants born to women who are treated with INVEGA ^® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. Tell your healthcare professional if you are breastfeeding or plan to breastfeed. INVEGA^® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA^®.

INVEGA^® may impair fertility, which is reversible. Speak to your healthcare professional if you plan to become pregnant.

The most common side effects that occurred with INVEGA^® in the treatment of schizophrenia in adults were: abnormal muscle movements (including tremor [shaking]), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes); feeling of inner restlessness or needing to be constantly moving; and fast heartbeat.

The most common side effects that occurred with INVEGA^® in the treatment of schizoaffective disorder in adults were: abnormal muscle movements (including tremor [shaking]), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes), sleepiness, heartburn, constipation, weight increase, and sore throat.

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

If you have any questions about INVEGA^® or your therapy, talk with your healthcare professional

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

Please click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA^® and discuss any questions you have with your healthcare professional.

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This information is intended for the use of patients and caregivers in the United States and Puerto Rico only. Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

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