Label Changes for:

Invega (paliperidone) 1.5 mg, 3 mg, 6 mg, and 9 mg Extended-Release tablets

July 2009

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009

PRECAUTIONS

Leukopenia, Neutropenia and Agranulocytosis
  • Class Effect: In clinical trial and/or postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including Invega. Agranulocytosis has also been reported.
  • Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia. Patients with a history of a clinically significant low WBC or drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of Invega should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
  • Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue Invega and have their WBC followed until recovery.
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