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Deferoxamine Mesylate for Injection is an iron-chelating agent indicated: • As an adjunct to standard measures for the treatment of acute iron intoxication. ( 1.1 ) • For the treatment of transfusional iron overload in patients with chronic anemia. ( 1.2 ) Limitations of Use Deferoxamine Mesylate for Injection is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder). 1.1 Acute Iron Intoxication Deferoxamine Mesylate for Injection is indicated as an adjunct to standard measures for the treatment of acute iron intoxication. 1.2 Chronic Iron Overload Deferoxamine Mesylate for Injection is indicated for the treatment of transfusional iron overload in patients with chronic anemia. 1.3 Limitations of Use Deferoxamine Mesylate for Injection is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).

Deferoxamine Mesylate for Injection is contraindicated in patients with: • A history of a hypersensitivity reaction to deferoxamine or any of its inactive ingredients [see Description ( 11 )] . Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )] . • Severe renal disease or anuria since the drug and the iron chelate are excreted primarily by the kidney [see Warnings and Precautions ( 5.3 )] . • Known hypersensitivity to the active substance. ( 4 ) • Patients with severe renal disease or anuria. ( 4 )

• Hypersensitivity Reactions: More common with rapid intravenous infusion. Administer intramuscularly or by slow subcutaneous or intravenous infusion. ( 5.1 ) Auditory and Ocular Toxicity: Have been reported when administered over prolonged periods of time, at high doses, or in patients with low ferritin levels. ( 5.2 ) • Renal Toxicity: Cases of acute renal failure, renal tubular disorders and increase in serum creatinine have occurred. Monitor patients for changes in renal function. ( 5.3 ) • Respiratory Toxicity: Acute respiratory distress syndrome has occurred. Risk increased with high intravenous doses. Recommended daily dose should not be exceeded. ( 5.4 ) • Growth Suppression: Has occurred in pediatric patients treated with high doses and concomitant low ferritin levels. Dose reduction may partially resume growth velocity to pre-treatment rates. ( 5.5 ) • Serious Infections: Cases of mucormycosis and Yersinia infections, some fatal, have occurred. Discontinue Deferoxamine Mesylate for Injection and initiate appropriate treatment immediately. ( 5.6 ) • Cardiac Dysfunction with Concomitant Use of Vitamin C: Avoid coadministration in patients with cardiac failure. Delay Vitamin C for one month after start of Deferoxamine Mesylate for Injection. Avoid exceeding 200 mg daily in adults. Monitor cardiac function with combined treatment. ( 5.7 ) • Risks of Deferoxamine Mesylate for Injection Treatment in Patients with Aluminum Overload: Risks include neurological dysfunction …

8.1 Pregnancy Risk Summary There are no available data on Deferoxamine Mesylate for Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriages or adverse maternal or fetal outcomes. In animal reproduction studies subcutaneous administration of deferoxamine to pregnant animals (mice or rabbits) during organogenesis at doses approximately ≥0.2- (mice) and ≥0.7 (rabbits) times the maximum recommended human dose resulted in maternal toxicity and adverse developmental outcomes (see Data ) . Advise pregnant women of the potential risk to a fetus. Consider the benefits and risks of Deferoxamine Mesylate for Injection for the mother and possible …