Padcev Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in males and females: Pregnancy testing is recommended for females of reproductive potential within 7 days prior to initiating treatment. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 12 months after stopping treatment. Men being treated with enfortumab vedotin are advised not to father a child during treatment and for up to 9 months following the last dose of PADCEV.
Pregnancy: PADCEV can cause foetal harm when administered to pregnant women based upon findings from animal studies. Embryo-foetal development studies in female rats have shown that intravenous administration of enfortumab vedotin resulted in reduced numbers of viable foetuses, reduced litter size, and increased early resorptions (see Pharmacology: Toxicology: Preclinical safety data under Actions). PADCEV is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
Breast-feeding: It is unknown whether enfortumab vedotin is excreted in human milk. A risk to breast-fed children cannot be excluded. Breast-feeding should be discontinued during PADCEV treatment and for at least 6 months after the last dose.
Fertility: In rats, repeat dose administration of enfortumab vedotin resulted in testicular toxicity and may alter male fertility. MMAE has been shown to have aneugenic properties (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, men being treated with this medicinal product are advised to have sperm samples frozen and stored before treatment. There are no data on the effect of PADCEV on human fertility.