Jadenu Use In Pregnancy & Lactation

Pregnant Women: There are no adequate and well-controlled studies conducted in pregnant women. No clinical data on exposed pregnancies are available for deferasirox. Studies in animals have shown some reproductive toxicity at maternally toxic doses (see Pharmacology: Toxicology: Reproduction and Teratology under Actions). The potential risk for humans is unknown. It is therefore recommended that JADENU should not be used during pregnancy. Patients taking oral contraceptives may be at risk of getting pregnant because JADENU may decrease the efficacy of hormonal contraceptives (see Interactions).
Nursing Women: It is not known whether deferasirox is excreted in human milk. In an animal study, deferasirox and its metabolites were present in breast milk of rats following a 10 mg/kg oral dose. The concentration of deferasirox was approximately 20-fold higher in maternal milk than in maternal plasma 4-8 hours post dose (see Pharmacology: Toxicology: Reproduction and Teratology under Actions). Therefore, women should be advised against breast-feeding while taking JADENU.