Pregnancy: There are no adequate and well-controlled trials of aripiprazole in pregnant women. Congenital anomalies have been reported; however, causal relationship with aripiprazole could not be established. Animal studies could not exclude potential developmental toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Patients must be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Abilify Maintena. Due to insufficient safety information in humans and concerns raised by animal reproductive studies, this medicinal product should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the foetus.
Prescribers need to be aware of the long-acting properties of Abilify Maintena.
Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalisation. Consequently, neonates should be monitored carefully (see Adverse Reactions).
Abilify Maintena should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Breast-feeding: Aripiprazole is excreted in human breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Abilify Maintena therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: Aripiprazole did not impair fertility based on data from reproductive toxicity studies.