Ninlaro Use In Pregnancy & Lactation

As IXAZOMIB 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 is not recommended in women of childbearing potential not using contraception.
When IXAZOMIB 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 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.
There are no data for the use of IXAZOMIB in pregnant women. Studies in animals have shown reproductive toxicity (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).
IXAZOMIB 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 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 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 (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).