Opdivo Use In Pregnancy & Lactation

Use in Pregnancy: There are no data on the use of nivolumab in pregnant women. Studies in animals have shown embryofetal toxicity (see Pharmacology: Toxicology under Actions). Human IgG4 is known to cross the placental barrier and nivolumab is an IgG4; therefore nivolumab has the potential to be transmitted from the mother to the developing foetus. Nivolumab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk. Effective contraception should be used for at least 5 months following the last dose of OPDIVO.
Use in Lactation: It is unknown whether nivolumab is secreted in human milk. Because many medicinal products, including antibodies, can be secreted in human milk, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast feeding or to discontinue from nivolumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.