Pregnancy: US Pregnancy category C: Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
There are no adequate and well-controlled studies with deferasirox in pregnant women. It is not known if deferasirox crosses the human placenta. The molecular weight (about 373) and long elimination half-life suggest that exposure of the embryo and/or fetus will occur, but the very high protein binding should limit the exposure. Administration of deferasirox to animals during pregnancy resulted in decreased offspring viability and an increase in renal anomalies in male offspring at exposures that were less than the recommended human exposure.
Labor and delivery: Data is not available.
Lactation: It is not known whether deferasirox is excreted in human milk. The molecular weight (about 373) and long elimination half-life (8-16 hours) suggest that the drug also will be excreted into breast milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding infants from deferasirox and its metabolites, decide whether to discontinue the breast-feeding or the drug, taking into account the importance of the drug to the mother.