Monitor neonates exhibiting extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately.In animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits.Pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day which are approximately 1 to 10 times the MRHD of 30 mg/day on mg/mIn pregnant rats treated with aripiprazole intravenously at doses of 3, 9, and 27 mg/kg/day, which are 1 to 9 times the oral MRHD on mg/mIn pregnant rabbits treated with oral doses of 10, 30, and 100 mg/kg/day which are 2 to 11 times human exposure at the oral MRHD based on AUC and 6 to 65 times the oral MRHD of aripiprazole on mg/mIn pregnant rabbits receiving aripiprazole injection intravenously at doses of 3, 10, and 30 mg/kg/day, which are 2 to 19 times the oral MRHD on mg/mIn rats treated with oral doses of 3, 10, and 30 mg/kg/day, which are 1 to 10 times the oral MRHD of aripiprazole on mg/mIn rats treated with aripiprazole intravenously at doses of 3, 8, and 20 mg/kg/day which are 1 to 6 times the oral MRHD on mg/mAripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. Advise pregnant women of potential fetal risk.The background risk of major birth defects and miscarriage for the indicated population are unknown. This information is intended for U.S. healthcare professionals only.To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (As circumstances related to the COVID-19 situation continue to unfold, Otsuka and Lundbeck are here to support you.As circumstances related to the COVID-19 situation continue to unfold, Otsuka and Lundbeck are here to support you.All doses can be given by deltoid or gluteal IM administrationOnly for administration by a healthcare professional
In the short-term, placebo-controlled trial of Abilify Maintena in adults with schizophrenia, the incidence of dystonia was 1.8% for Abilify Maintena vs. 0.6% for placebo.In the short-term, placebo-controlled trial of Abilify Maintena in adults with schizophrenia, the incidence of neutropenia (absolute neutrophil count ≤1.5 thous/mcL) for Abilify Maintena-treated patients was 5.7% vs. 2.1% for placebo. Compulsive behaviors may result in harm to the patient and others if not recognized. After administration of multiple doses of 4300 mg of 00 mg or Abilify Maintena, the observed mean aripiprazole terminal elimination half-life is 46.5 and 29.9 days, respectively. There are insufficient data with Abilify Maintena use in pregnant women to inform a drug-associated risk. For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), after the first Abilify Maintena injection, continue treatment with the antipsychotic for 14 consecutive days to maintain therapeutic antipsychotic concentrations during initiation of therapy.If there are adverse reactions with the 400-mg dosage, consider reducing the dosage to 300 mg once monthly.Dosage adjustments are recommended in patients who are CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days (see If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the Abilify Maintena dosage may need to be increased Avoid the concomitant use of CYP3A4 inducers with Abilify Maintena for greater than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels.Dosage adjustments are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days.Abilify Maintena comes in two types of kits.