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Label Changes for:

Abilify (aripiprazole) 9.75 mg / 1.3 mL (7.5 mg /mL) Injection

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

  • Abilify (aripiprazole) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets
  • Abilify (aripiprazole) 1 mg / mL Oral Solution
  • Abilify Discmelt (aripiprazole)  10 mg and 15 mg Orally Disintegrating Tablets
  • Abilify (aripiprazole) 9.75 mg / 1.3 mL (7.5 mg / mL) Injection


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 Abilify. 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 Abilify 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 Abilify and have their WBC followed until recovery.