Adcetris Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential should be using two methods of effective contraception during treatment with BRENTUXIMAB VEDOTIN (ADCETRIS) and until 6 months after treatment.
Pregnancy: There are no data from the use of BRENTUXIMAB VEDOTIN (ADCETRIS) in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
BRENTUXIMAB VEDOTIN (ADCETRIS) should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus. If a pregnant woman needs to be treated, she should be clearly advised on the potential risk to the foetus.
See Fertility as follows pertaining to advice for women whose male partners are being treated with BRENTUXIMAB VEDOTIN (ADCETRIS).
Breastfeeding: There are no data as to whether brentuximab vedotin or its metabolites are excreted in human milk.
A risk to the newborn/infant cannot be excluded.
A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from this therapy, taking into account a potential risk of breast-feeding for the child and the benefit of therapy for the woman.
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 (see Pharmacology: Toxicology: Preclinical safety data under Actions). 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.