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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

versus 4% for placebo.

Seizures: In short-term placebo-controlled trials (4- to 6-weeks), seizures occurred in 0.1% (1/1344) of patients treated with Fanapt compared to 0.3% (2/587) on placebo. As with other antipsychotics, Fanapt should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.

Orthostatic Hypotension and Syncope: Fanapt can induce orthostatic hypotension and syncope. Fanapt should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that predispose the patient to hypotension.

Leukopenia, Neutropenia, and Agranulocytosis: In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents. Agranulocytosis (including fatal cases) have been reported. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue Fanapt at the first sign of a decline in WBC in the absence of other causative factors.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, Fanapt elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia and impotence have been reported in patients receiving prolactin-elevating compounds.

Body Temperature Regulation: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing Fanapt for patients who will be experiencing conditions which may contribute to an elevation in core body temperature.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity an
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SOURCE Novartis Pharmaceuticals Corporation
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