Deferoxamine Mesylate
Generic Name: deferoxamine mesylate
Brand Names:
Deferoxamine Mesylate
11 DESCRIPTION Deferoxamine mesylate for injection USP, is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Deferoxamine mesylate for injection USP, is supplied as vials containing 500 mg and 2 grams of deferoxamine mesylate USP (corresponding to 426.82 mg and 1.707 grams of deferoxamine as free base) in sterile, lyophilized form.
Overview
11 DESCRIPTION Deferoxamine mesylate for injection USP, is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Deferoxamine mesylate for injection USP, is supplied as vials containing 500 mg and 2 grams of deferoxamine mesylate USP (corresponding to 426.82 mg and 1.707 grams of deferoxamine as free base) in sterile, lyophilized form.
Uses
1 INDICATIONS AND USAGE 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. ( 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).
Dosage
2 DOSAGE AND ADMINISTRATION SECTION 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: ( 2.1 ) 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. Maximum dose is 6,000 mg in 24 hours.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Auditory and Ocular Toxicity [see Warnings and Precautions ( 5.2 )] Renal Toxicity [see Warnings and Precautions ( 5.3 )] Respiratory Toxicity [see Warnings and Precautions ( 5.4 )] Growth Suppression [see Warnings and Precautions ( 5.5 )] Serious Infections [see Warnings and Precautions ( 5.6 )] Cardiac Dysfunction with Concomitant Use of Vitamin C [see Warnings and Precautions ( 5.7 )] Risks of Deferoxamine mesylate Treatment in Patients with Aluminum Overload [see Warnings and Precautions ( 5.8 )] Effects on Ability to Drive and Use Machines [see Warnings and Precautions ( 5.9 )] Most common adverse reaction...
Interactions
7 DRUG INTERACTIONS Concurrent treatment with prochlorperazine may lead to temporary impairment of consciousness. ( 7.1 ) Imaging results may be distorted due to rapid urinary excretion of deferoxamine mesylate bound gallium-67. Discontinue deferoxamine mesylate 48 hours prior to scintigraphy. ( 7.2 ) 7.1 Prochlorperazine Concurrent treatment with deferoxamine mesylate and prochlorperazine, a phenothiazine derivative, may lead to temporary impairment of consciousness. 7.2 Gallium-67 Imaging results may be distorted because of the rapid urinary excretion of deferoxamine mesylate-bound gallium-67. Discontinue deferoxamine mesylate 48 hours prior to scintigraphy.
Warnings
5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS 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 )] .
Pregnancy
8.1 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. 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Deferoxamine mesylate for injection USP, is supplied in single-dose vials containing 500 mg and 2 grams of deferoxamine mesylate (corresponding to 426.82 mg and 1.707 grams of deferoxamine as free base) as a sterile, white to off-white lyophilized powder.
Frequently Asked Questions
What is Deferoxamine Mesylate used for?▼
1 INDICATIONS AND USAGE 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. ( 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).
What are the side effects of Deferoxamine Mesylate?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Auditory and Ocular Toxicity [see Warnings and Precautions ( 5.2 )] Renal Toxicity [see Warnings and Precautions ( 5.3 )] Respiratory Toxicity [see Warnings and Precautions ( 5.4 )] Growth Suppression [see Warnings and Precautions ( 5.5 )] Serious Infections [see Warnings and Precautions ( 5.6 )] Cardiac Dysfunction with Concomitant Use of Vitamin C [see Warnings and Precautions ( 5.7 )] Risks of Deferoxamine mesylate Treatment in Patients with Aluminum Overload [see Warnings and Precautions ( 5.8 )] Effects on Ability to Drive and Use Machines [see Warnings and Precautions ( 5.9 )] Most common adverse reaction...
Can I take Deferoxamine Mesylate during pregnancy?▼
8.1 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. 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.
What are the important warnings for Deferoxamine Mesylate?▼
5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS 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 )] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.