Pregnancy: There are no adequate and well-controlled studies with Adcetris in pregnant women. Adcetris may cause fetal harm when administered to pregnant women; therefore women who are pregnant should not begin treatment with Adcetris.
Women of childbearing potential should be advised not to become pregnant while taking this medicine, and must use effective methods to prevent pregnancy from the start of treatment with Adcetris and must continue for 6 months following the last dose of Adcetris. If the patient becomes pregnant while taking Adcetris, the patient should be apprised of the potential hazard to the fetus.
Adcetris was studied for effects on embryo-fetal development in pregnant female rats. The no-observed-adverse-effect-level of Adcetris when administered to pregnant rats was 1 mg/kg/dose.
It is not known if using Adcetris will affect human spermatogenesis. In nonclinical studies, Adcetris resulted in testicular toxicity which was partially resolved 16-weeks post last dose administration. Therefore, due to this potential risk, men should be advised not to impregnate their partner during treatment with Adcetris. Men of reproductive potential must use an appropriate method of barrier contraception throughout treatment with Adcetris and for at least 6 months following the last dose of Adcetris (See Precautions).
Lactation (Breastfeeding): It is not known whether Adcetris or MMAE are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Adcetris, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of Adcetris to the mother.
Fertility: In non-clinical studies, brentuximab vedotin treatment has resulted in testicular toxicity, and may alter male fertility. MMAE has been shown to have aneugenic properties. Therefore, men being treated with this medicine are advised to have sperm samples frozen and stored before treatment. Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months following the last dose.