Ninlaro Use In Pregnancy & Lactation

As IXAZOMIB (NINLARO) is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional information on fertility, pregnancy and lactation.
Women of childbearing potential/Contraception in males and females: Male and female patients who are able to have children must use effective contraceptive measures during and for 90 days following treatment. IXAZOMIB (NINLARO) is not recommended in women of childbearing potential not using contraception.
When IXAZOMIB (NINLARO) is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of oral contraceptives needs to be considered. Therefore, women using oral hormonal contraceptives should additionally use a barrier method of contraception.
Pregnancy: IXAZOMIB (NINLARO) is not recommended during pregnancy as it can cause foetal harm when administered to a pregnant woman. Therefore, women should avoid becoming pregnant while being treated with IXAZOMIB (NINLARO).
There are no data for the use of IXAZOMIB (NINLARO) in pregnant women. Studies in animals have shown reproductive toxicity.
IXAZOMIB (NINLARO) is given in combination with lenalidomide, Lenalidomide is structurally related to thalidomide. Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects. If lenalidomide is taken during pregnancy, a teratogenic effect in humans is expected. The conditions of the Pregnancy Prevention Programme for lenalidomide must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential. Please refer to the current lenalidomide SmPC.
Breast feeding: It is unknown whether IXAZOMIB (NINLARO) or its metabolites are excreted in human milk. No animal data are available. A risk to newborns/infants cannot be excluded and therefore breast feeding should be discontinued.
IXAZOMIB (NINLARO) will be given in combination with lenalidomide and breast-feeding should be stopped because of the use of lenalidomide.
Fertility: Fertility studies have not been conducted with IXAZOMIB (NINLARO).