Darzalex Use In Pregnancy & Lactation

Pregnancy: There are no human or animal data to assess the risk of Daratumumab (Darzalex) use during pregnancy. IgG1 monoclonal antibodies are known to cross the placenta after the first trimester of pregnancy. Therefore Daratumumab (Darzalex) 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 drug, the patient should be informed of the potential risk to the fetus.
To avoid exposure to the fetus, women of reproductive potential should use effective contraception during and for 3 months after cessation of Daratumumab (Darzalex) treatment.
Breast-feeding: It is not known whether daratumumab is excreted into human or animal milk or affects milk production.
There are no studies to assess the effect of daratumumab on the breast-fed infant.
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. Because the risks of Daratumumab (Darzalex) to the infant from oral ingestion are unknown, a decision should be made whether to discontinue breast-feeding, or discontinue Daratumumab (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.