Pregnancy: Risk Summary: Based on its mechanism of action and data from animal reproduction studies, Ninlaro can cause fetal harm when administered to a pregnant woman [see Pharmacology under Actions]. There are no human data available regarding the potential effect of Ninlaro on pregnancy or development of the embryo or fetus. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher then those observed in patients receiving the recommended dose. Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with Ninlaro.
Lactation: Risk Summary: No data are available regarding the presence of Ninlaro or its metabolites in human milk. The effects of the drug on the breast fed infant, or the effects of the drug on milk production. Because the potential for serious adverse reactions from Ninlaro in breastfed infants is unknown, advise nursing women not to breastfeed during treatment with Ninlaro and for 90 days after the last dose.
Females and Males of Reproductive Potential: Contraception: Male and female patients of childbearing potential must use effective contraceptive measures during and for 90 days following treatment. Dexamethasone is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters. Because Ninlaro is administered with dexamethasone, the risk for reduced efficacy of contraceptives needs to be considered. Advise women using hormonal contraceptives to also use a barrier method of contraception.