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 human or animal data to assess the risk of daratumumab use during pregnancy. IgG1 monoclonal antibodies are known to cross the placenta after the first trimester of pregnancy. Therefore daratumumab should not be used during pregnancy unless the benefit of treatment to the woman is considered to outweigh the potential risks to the fetus. If the patient becomes pregnant while taking this medicine, the patient should be informed of the potential risk to the fetus.
Breast-feeding: It is not known whether daratumumab is excreted into human or animal milk.
Maternal IgG is excreted in human milk, but does not enter the neonatal and infant circulations in substantial amounts as they are degraded in the gastrointestinal tract and not absorbed.
The effect of daratumumab on newborns/infants is unknown. A decision should be made whether to discontinue breast feeding or to discontinue 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).