Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload

Exclusion Criteria

• •Ongoing treatment with another iron chelator (Any other iron chelation therapy must be discontinued at least 24 hours prior to study entry.)
• •Patients who meet the eligibility criteria for any other ongoing Novartis sponsored clinical study protocol with deferasirox and who have geographic access to these sites
• •Patients unable to tolerate (or who have unacceptable toxicities to) prior treatment with deferasirox
• •Serum creatinine above the upper limit of normal at screening.
• •Patients with ALT ≥ 500 U/L at screening.
• •Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline
• •Pregnancy (as indicated by serum β-HCG pregnancy test at screening for all female patients with the potential to become pregnant) and patients who are breastfeeding
• •Patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit