In a prenatal and postnatal developmental study, pregnant rats received oral deferasirox daily from organogenesis through lactation day 20 at doses (10, 30, and 90 mg/kg/day) 0.08, 0.2, and 0.7 times the MRHD on a mg/m2 basis. Maternal toxicity, loss of litters, and decreased offspring viability occurred at 0.7 times the MRHD on a mg/m2 basis, and increases in renal anomalies in male offspring occurred at 0.2 times the MRHD on a mg/m2 basis.

8.3 Nursing Mothers
It is not known whether Exjade is excreted in human milk. Deferasirox and its metabolites were excreted in rat milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from deferasirox and its metabolites, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use
Of the 700patients who received Exjade during clinical studies, 292 were pediatric patients 2-<16years of age with various congenital and acquired anemias, including 52patients age 2-<6years, 121patients age 6-<12years and 119patients age 12-<16years. Seventy percent of these patients had β-thalassemia. Children between the ages of 2-<6years have a systemic exposure to Exjade approximately 50% of that of adults [see Clinical Pharmacology(12.3)]. However, the safety and efficacy of Exjade in pediatric patients was similar to that of adult patients, and younger pediatric patients responded similarly to older pediatric patients. The recommended starting dose and dosing modification are the same for children and adults [see Clinical Studies(14), Indications and Usage(1), and Dosage and Administration(2.1)].

Growth and development were within normal limits in children followed for up to 5 years in clinical trials.

8.5 Geriatric Use
Four hundred and thirty-one (431) patients ≥65years of age have been studied in clinical trials of Exjade. The majority of these patients had myelodysplastic syndrome (MDS)(n=393). In these trials, elderly patients experienced a higher frequency of adverse reactions than younger patients. Closely monitor elderly patients for early signs or symptoms of adverse reactions that may require a dose adjustment. Elderly patients are at increased risk for Exjade toxicity due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Renal Impairment
Exjade has not been studied in patients with renal impairment [see Warnings and Precautions (5.1)].

8.7 Hepatic Impairment
In a single dose (20 mg/kg) study in patients with varying degrees of hepatic impairment, deferasirox exposure was increased compared to patients with normal hepatic function. The average total (free and bound) AUC of deferasirox increased 16% in 6 subjects with mild (Child-Pugh A) hepatic impairment, and 76% in 6 subjects with moderate (Child-Pugh B) hepatic impairment compared to 6 subjects with normal hepatic function. The impact of severe (Child-Pugh C) hepatic impairment was assessed in only one subject.

Avoid the use of Exjade in patients with severe (Child-Pugh C) hepatic impairment. For patients with moderate (Child-Pugh B) hepatic impairment, the starting dose should be reduced by 50%. Closely monitor patients with mild (Child-Pugh A) or