Alecensa Use In Pregnancy & Lactation

Use in Pregnancy: Women of childbearing potential must be advised to avoid pregnancy while on Alecensa. No clinical studies of Alecensa in pregnant women have been performed. Based on its mechanism of action, Alecensa may cause fetal harm when administered to a pregnant woman.
Female patients or women who are partners of male patients receiving Alecensa, who become pregnant while taking Alecensa or during the 3 months following the last dose of Alecensa must contact their doctor and should be advised of the potential harm to the fetus.
Animal data: In animal studies, alectinib caused embryo-fetal toxicity (Pharmacology: Toxciology: Non-clinical Safety under Actions).
Labor and delivery: The safe use of Alecensa during labor and delivery has not been established.
Use in Lactation: It is not known whether Alecensa is excreted in human breast milk. No studies have been conducted to assess the impact of Alecensa on milk production or its presence in breast milk. As many drugs are excreted in human milk and because of the potential harm to the infant, mothers should be advised against breastfeeding while receiving Alecensa.