Alunbrig Use In Pregnancy & Lactation

Pregnancy: Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, brigatinib can cause fetal harm when administered to pregnant women. There are no clinical data on the use brigatinib in pregnant women.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with brigatinib and for at least 4 months following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of brigatinib.
Brigatinib may cause fetal harm when administered to a pregnant woman. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Nonclinical Safety Data under Actions). There are no clinical data on the use of brigatinib in pregnant women. Brigatinib should not be used during pregnancy unless the clinical condition of the mother requires treatment. If brigatinib is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Women of childbearing age being treated with brigatinib should be advised not to become pregnant and men being treated with brigatinib should be advised not to father a child during treatment. Women of reproductive potential should be advised to use effective non-hormonal contraception during treatment with brigatinib and for at least 4 months following the final dose. Male patient with female partners of reproductive potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose of brigatinib.
In an embryo-fetal development study in which pregnant rats were administered daily doses of brigatinib during organogenesis, dose-related skeletal (incomplete ossification, small incisors) and visceral anomalies were observed at doses as low as 12.5 mg/kg/day (approximately 0.7 times the human exposure by AUC at 180 mg once daily). Malformations observed at 25 mg/kg/day (approximately 1.26 times the human AUC at 180 mg once daily) included anasarca (generalized subcutaneous edema), anophthalmia (absent eyes), forelimb hyperflexion, small, short and/or bent limbs, multiple fused ribs, bent scapulae, omphalocele (intestine protruding into umbilicus), and gastroschisis (intestines protruding through a defect in the abdominal wall) along with visceral findings of moderate bilateral dilatation of the lateral ventricles.
Lactation: It is unknown whether brigatinib is excreted in human milk. Available data cannot exclude potential excretion in human milk. Breast-feeding should be stopped during treatment with brigatinib.
Fertility: No human data on the effect of brigatinib on fertility are available. Based on reproductive studies in male animals, brigatinib may cause reduced fertility in males (see Pharmacology: Toxicology: Nonclinical Safety Data under Actions). The clinical relevance of these findings to human fertility is unknown.