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INVEGA(TM) Significantly Reduced Symptoms of Schizophrenia Compared to SEROQUEL(R) in Acutely Ill, Hospitalized Patients
Date:10/13/2007

d women affected equally. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well as by disorganized thinking.

IMPORTANT SAFETY INFORMATION FOR INVEGA(TM)

INVEGA(TM) (paliperidone) Extended-Release Tablets is indicated for the acute and maintenance treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION FOR INVEGA(TM)

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 healthcare 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
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SOURCE Janssen, L.P. and Johnson & Johnson
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