FDA Approves INVEGA™ (paliperidone) For Long-Term Maintenance Treatment Of Schizophrenia

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IMPORTANT SAFETY INFORMATION FOR INVEGA™

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA™ (paliperidone) is not approved for the treatment of patients with dementia-related psychosis.

The most common side effects that occurred with INVEGA™ were restlessness and extrapyramidal disorder (for example: involuntary movements, tremors and muscle stiffness).

One risk of INVEGA™ is that it may change your heart rhythm. This effect is potentially serious, and you should talk to your doctor about any current or past heart problems. Some medications interact with INVEGA™. Please inform your health care professional of any medications or supplements that you are taking.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with INVEGA™ 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 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. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

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™ 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. There is no known connection between prolactin levels and side effects.

High blood sugar and diabetes have been reported with INVEGA™ 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 INVEGA™. 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.

People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach or small or large intestine) should talk to their health care 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 or it may go away over time.

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 health care professional.

Inform your health care professional if you are pregnant or if you are planning to get pregnant while taking INVEGA™. Do not breast-feed if you are taking INVEGA™.

INVEGA™ may affect your driving ability; therefore, do not drive or operate machines before talking to your health care professional. Avoid alcohol while on INVEGA™.

INVEGA™ may affect alertness and motor skills; use caution until the effect of INVEGA™ is known.

INVEGA™ 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.

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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.

Keep out of reach of children.

Please see full important U.S. prescribing information for INVEGA™ at www.janssen.com. 

Source: Johnson&Jonsonn

Last updated: 04/07

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