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Phase III Study Demonstrates INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) Statistically Similar to RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Injection
Date:12/10/2009

persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.

Orthostatic Hypotension: RISPERDAL® CONSTA® may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern. RISPERDAL® CONSTA® should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.

Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including risperidone. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have frequent complete blood cell counts during the first few months of therapy. At the first sign of a decline in WBC and in the absence of other causative factors, discontinuation of RISPERDAL® CONSTA® should be considered.

Potential for Cognitive and Motor Impairment: RISPERDAL® CONSTA® has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL® CONSTA® does not affect them adversely.

Seizures: RISPERDAL® CONSTA® should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold.

Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia.

Priapism has been reported. Severe priapism may require surgical intervention.

Thrombotic Thrombocytopenic Purpura (TTP) has been reported.

Administration: RISPERDAL® CONSTA® should be injected into the deltoid or gluteal muscle,
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SOURCE Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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