Adcetris

Adcetris Use In Pregnancy & Lactation

brentuximab vedotin

Manufacturer:

Takeda

Distributor:

DKSH
Full Prescribing Info
Use In Pregnancy & Lactation
Women of childbearing potential: Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment.
Pregnancy: There are no data from the use of ADCETRIS in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
ADCETRIS may cause fetal harm when administered to pregnant women; therefore women who are pregnant should not begin treatment with ADCETRIS unless the benefit to the mother outweighs the potential risks to the foetus. If the patient becomes pregnant while taking ADCETRIS, the patient should be clearly advised on the potential risks to the foetus.
See the fertility as follows pertaining to advice for women whose male partners are being treated with ADCETRIS.
Breastfeeding: There are no data as to whether ADCETRIS 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, ADCETRIS treatment has resulted in testicular toxicity, and may alter male fertility. MMAE has been shown to have aneugenic properties (see Pharmacology: Toxicology: Preclinical safet 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.
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