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Women of child-bearing potential/Contraception: Women of child-bearing potential should use effective contraception during, and for 3 months after cessation of daratumumab treatment.
Pregnancy: There are no or limited amount of data from the use of daratumumab in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). DARZALEX is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is not known whether daratumumab is excreted into human or animal milk.
A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from DARZALEX therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: No data are available to determine potential effects of daratumumab on fertility in males or females (see Pharmacology: Toxicology: Preclinical safety data under Actions).
