Rybrevant Use In Pregnancy & Lactation

Pregnancy: There are no human or animal data to assess the risk of RYBREVANT in pregnancy. Administration of other EGFR and MET inhibitor molecules to pregnant animals has resulted in an increased incidence of impairment of embryo-fetal development, embryolethality, and abortion. Therefore, based on its mechanism of action and findings in animal models, RYBREVANT could cause fetal harm when administered to a pregnant woman.
RYBREVANT should not be used during pregnancy unless the benefit of treatment to the woman is considered to outweigh potential risks to the fetus. If the patient becomes pregnant while taking this drug, the patient should be informed of the potential risk to the fetus.
Breast-feeding: It is not known whether RYBREVANT is excreted in human or animal milk or affects milk production. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from amivantamab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Because of the potential for serious adverse reactions from RYBREVANT in breast-fed infants, advise women not to breast-feed during treatment with RYBREVANT and for 3 months following the last dose of RYBREVANT.
Contraception: Due to the risk that RYBREVANT can cause fetal harm when administered to pregnant women, advise female patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT. Male patients must use effective contraception (e.g., condom) and not donate or store semen during treatment and for 3 months after the last dose of RYBREVANT.
Fertility: No data are available to determine potential effects of RYBREVANT on fertility in males or females.