Finished product reference
Deferoxamine Mesylate
Injection, Powder, for Solution · Parenteral · 500 mg
- List code
- 386
What it is and how it works
Mechanism of Action Deferoxamine mesylate chelates iron by forming a stable complex that prevents the iron from entering into further chemical reactions. It readily chelates iron from ferritin and hemosiderin but not readily from transferrin; it does not combine with the iron from cytochromes and hemoglobin. Deferoxamine mesylate does not cause any demonstrable increase in the excretion of electrolytes or trace metals. Theoretically, 100 parts by weight of deferoxamine mesylate is capable of binding approximately 8.5 parts by weight of ferric iron.
Indications
Deferoxamine mesylate for injection is an iron-chelating agent indicated: 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). As an adjunct to standard measures for the treatment of acute iron intoxication. For the treatment of transfusional iron overload in patients with chronic anemia. 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). Acute Iron Intoxication Deferoxamine mesylate for injection is indicated as an adjunct to standard measures for the treatment of acute iron intoxication. Chronic Iron Overload Deferoxamine mesylate for injection is indicated for the treatment of transfusional iron overload in patients with chronic anemia.
Dosage and administration (summary)
The dosage (based on body weight in mg/kg/day), rates of administration, and mode of administration for both adults and pediatric patients are individually determined and adapted during the course of therapy based on the severity of the patient’s iron overload. The minimum daily dose of deferoxamine mesylate for injection is 20 mg/kg/day for both adults and pediatric patients. The maximum daily dose is 40 mg/kg/day for pediatric patients and 60 mg/kg/day for adults. Acute Iron Intoxication: Intramuscular Administration: Use for patients not in shock. Initial dose is 1,000 mg. Depending upon the clinical response, subsequent doses of 500 mg may be administered every 4 hours to 12 hours.
Contraindications
Deferoxamine mesylate for injection is contraindicated in patients with: A history of a hypersensitivity reaction to deferoxamine or any of its inactive ingredients . Reactions have included anaphylaxis . Severe renal disease or anuria since the drug and the iron chelate are excreted primarily by the kidney . Known hypersensitivity to the active substance. Patients with severe renal disease or anuria.
Warnings and precautions
Hypersensitivity Reactions: More common with rapid intravenous infusion. Administer intramuscularly or by slow subcutaneous or intravenous infusion. Auditory and Ocular Toxicity: Have been reported when administered over prolonged periods of time, at high doses, or in patients with low ferritin levels. Renal Toxicity: Cases of acute renal failure, renal tubular disorders and increase in serum creatinine have occurred. Monitor patients for changes in renal function. Respiratory Toxicity: Acute respiratory distress syndrome has occurred. Risk increased with high intravenous doses.
Pregnancy
Pregnancy Risk Summary There are no available data on deferoxamine mesylate use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriages or adverse maternal or fetal outcomes.
Storage and supply
How Supplied Deferoxamine mesylate for injection USP, is supplied in single-dose vials containing 500 mg and 2 g of deferoxamine mesylate (corresponding to 426.82 mg and 1.707 g of deferoxamine as free base) as a sterile, white to off-white lyophilized powder.
Source: Deferoxamine Mesylate (Deferoxamine Mesylate) — US FDA prescribing information, 2026-05-29, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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