Brigatinib

The Basics

What is Brigatinib?

Used to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to other parts of the body.

Brand names for Brigatinib

Alunbrig

How Brigatinib is classified

Antineoplastic Agents, Enzyme Inhibitors, Protein Kinase Inhibitors, Signal Transduction Inhibitors, Tyrosine Kinase Inhibitors

Brigatinib During Pregnancy

Brigatinib pregnancy category

Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Brigatinib while pregnant

Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to a pregnant woman [see Data and CLINICAL PHARMACOLOGY]. There are no clinical data on the use of ALUNBRIG in pregnant women. Administration of brigatinib to pregnant rats during the period of organogenesis resulted in dose-related skeletal anomalies at doses as low as 12.5 mg/kg/day (approximately 0.7 times the human exposure by AUC at 180 mg once daily) as well as increased post-implantation loss, malformations, and decreased fetal body weight at doses of 25 mg/kg/day (approximately 1.26 times the human exposure at 180 mg once daily) or greater. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data 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.

Taking Brigatinib While Breastfeeding

What are recommendations for lactation if you're taking Brigatinib?

No information is available on the clinical use of brigatinib during breastfeeding. The manufacturer recommends that breastfeeding be discontinued during brigatinib therapy and for 1 week after the final dose.

Maternal / infant drug levels

No information is available on the clinical use of brigatinib during breastfeeding. The manufacturer recommends that breastfeeding be discontinued during brigatinib therapy and for 1 week after the final dose.

Possible effects of Brigatinib on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Brigatinib