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Novartis Enters Into Agreement for Exclusive US and Canadian Rights to Fanapt(TM), an FDA-Approved Oral Therapy for Schizophrenia
Date:10/12/2009

tus, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.

Tardive Dyskinesia (TD): The risk of developing TD and the likelihood for it to become irreversible are believed to increase as the duration of treatment and the total cumulative dose increases. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Given these considerations Fanapt should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia.

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including Fanapt. Patients with risk factors for diabetes mellitus who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of and during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

Weight Gain: Based on the pooled data from the four placebo-controlled, 4- or 6-week, fixed- or flexible-dose studies, the proportions of patients having a weight gain of greater than or equal to 7% body weight was 12% for Fanapt 10-16 mg/day, 18% for Fanapt 20-24 mg/day, and 13% for Fanapt (combined doses)
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SOURCE Novartis Pharmaceuticals Corporation
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