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 )] .
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 )] .
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.
For injection: 500 mg of deferoxamine mesylate (corresponding to 426.82 mg of deferoxamine as free base) as a white to off-white lyophilized powder in single-dose vial for reconstitution. For injection: 2 g of deferoxamine mesylate (corresponding to 1.707 g of deferoxamine as free base) as a white to off-white lyophilized powder in single-dose vial for reconstitution.
Acute Toxicity Intravenous LD 50 s (mg/kg): mice, 287; rats, 329. Inadvertent administration of an overdose or inadvertent intravenous bolus administration/rapid intravenous infusion may be associated with hypotension, tachycardia and gastrointestinal disturbances; acute but transient loss of vision, aphasia, agitation, headache, nausea, pallor, CNS depression, including coma, bradycardia and acute renal failure have been reported. Acute respiratory distress syndrome has been reported following treatment with excessively high intravenous doses of deferoxamine mesylate for injection in patients with acute iron intoxication and in patients with thalassemia. There is no specific antidote for deferoxamine mesylate overdose. In case of overdose, discontinue deferoxamine mesylate and provide symptomatic supportive care. Deferoxamine mesylate is readily dialyzable.
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. Deferoxamine mesylate for injection USP, is supplied in cartons as follows: 500 mg/vial Cartons of 4 vials NDC 60505-6236-6 2 g/vial Cartons of 4 vials NDC 60505-6237-6 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Each vial is for single dose only. Discard unused portion.
Package Label – 500 mg per vial Rx Only NDC 60505-6236-6 Deferoxamine mesylate for injection, USP 500 mg per vial Each vial contains Deferoxamine mesylate USP, 500 mg in lyophilized form. For subcutaneous intramuscular or intravenous administration. 4 vials Package Label – 2 g per vial Rx Only NDC 60505-6237-6 Deferoxamine mesylate for injection, USP 2 g per vial Each vial contains Deferoxamine mesylate USP, 2 g in lyophilized form. For subcutaneous intramuscular or intravenous administration. 4 vials
| Name | UNII | Kind |
|---|---|---|
| DEFEROXAMINE MESYLATE | V9TKO7EO6K | ACTIB |
| DEFEROXAMINE MESYLATE | V9TKO7EO6K | ACTIB |
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.
For injection: 500 mg of deferoxamine mesylate (corresponding to 426.82 mg of deferoxamine as free base) as a white to off-white lyophilized powder in single-dose vial for reconstitution. For injection: 2 g of deferoxamine mesylate (corresponding to 1.707 g of deferoxamine as free base) as a white to off-white lyophilized powder in single-dose vial for reconstitution.
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 )] .
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 )]
Acute Toxicity Intravenous LD 50 s (mg/kg): mice, 287; rats, 329. Inadvertent administration of an overdose or inadvertent intravenous bolus administration/rapid intravenous infusion may be associated with hypotension, tachycardia and gastrointestinal disturbances; acute but transient loss of vision, aphasia, agitation, headache, nausea, pallor, CNS depression, including coma, bradycardia and acute renal failure have been reported. Acute respiratory distress syndrome has been reported following treatment with excessively high intravenous doses of deferoxamine mesylate for injection in patients with acute iron intoxication and in patients with thalassemia. There is no specific antidote for deferoxamine mesylate overdose. In case of overdose, discontinue deferoxamine mesylate and provide symptomatic supportive care. Deferoxamine mesylate is readily dialyzable.
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 of deferoxamine mesylate USP (corresponding to 426.82 mg of deferoxamine as free base) and 2 g of deferoxamine mesylate USP ( corresponding to 1.707 g of deferoxamine as free base) in sterile, lyophilized form. Deferoxamine mesylate is N-[5-[3-[(5-aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-(N-hydroxyacetamido) pentyl]carbamoyl]propionohydroxamic acid monomethanesulfonate (salt), and its structural formula is: Deferoxamine mesylate USP is a white crystalline powder. It is freely soluble in water and slightly soluble in methanol. Its molecular weight is 656.79 g/mol.
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. Deferoxamine mesylate for injection USP, is supplied in cartons as follows: 500 mg/vial Cartons of 4 vials NDC 60505-6236-6 2 g/vial Cartons of 4 vials NDC 60505-6237-6 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Each vial is for single dose only. Discard unused portion.
Caution patients about the potential allergic reactions associated with rapid intravenous administration of deferoxamine mesylate for injection and the need for monitoring allergic reactions during treatment [see Warnings and Precautions ( 5.1) ]. Caution patients about the potential auditory and ocular toxicities due to prolonged use of deferoxamine mesylate for injection, conduct auditory testing and ophthalmic testing at regular intervals. Advise patients to contact their healthcare provider if they develop visual or auditory changes during treatment [see Warnings and Precautions ( 5.2 )]. Caution patients about the potential for kidney toxicity when taking deferoxamine mesylate for injection and the need for kidney function test to monitor for increase in serum creatinine [see Warnings and Precautions ( 5.3 )]. Inform patients that if they have difficulty in breathing during treatment, they should inform the healthcare provider as this is a symptom of acute respiratory distress syndrome which can occur with excessively high intravenous doses of deferoxamine mesylate for injection [see Warnings and Precautions ( 5.4 )]. Caution pediatric patients and their caregivers that child treated with deferoxamine mesylate for injection could have slower than normal growth and the need to monitor for body weight and height every 3 months [see Warnings and Precautions ( 5.5 )]. Caution patients about the increased risk of bacterial infections (Yersinia enterocolitica and Yersinia pseudotuberculosis) with deferoxamine mesylate for injection treatment and the need for treatment discontinuation until the infection is resolved [see Warnings and Precautions ( 5.6 )]. Caution patients about the potential risk of fungal infections (Mucormycosis) when receiving deferoxamine mesylate for injection treatment and the need for treatment discontinuation, mycological tests and required treatment for treating the infection [see Warnings and Precautions ( 5.6 )]. Caution patients about the potential impairment of cardiac function when taking deferoxamine mesylate for injection concomitantly with high doses of Vitamin C (more than 500 mg daily in adults). Inform adult patients not to exceed a daily Vitamin C dose of 200 mg given in divided doses. Inform pediatric patients under 10 years of age and older pediatric patients or their care takers not to exceed a daily Vitamin C of 50 mg and 100 mg, respectively [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.7 )]. Inform patients with cardiac failure not to take Vitamin C supplements when on treatment with deferoxamine mesylate for injection [see Dosage and Administration (2.4) and Warnings and Precautions ( 5.7 )]. Caution patients with aluminum-related encephalopathy and receiving dialysis about potential neurological dysfunction [see Warnings and Precautions ( 5.8 )]. Cautions patients that treatment with deferoxamine mesylate for injection in the presence of aluminum overload may result in decreased serum calcium and aggravation of hyperparathyroidism [see Warnings and Precautions ( 5.8 )]. Inform patients that they should refrain from driving or operating potentially hazardous machines if they experience dizziness or other nervous system disturbances, or impairment of vision or hearing [see Warnings and Precautions ( 5.9 )]. Advise patients to inform the healthcare provider if they have received prochlorperazine prior to deferoxamine mesylate for injection treatment as this may lead to temporary impairment of consciousness [see Drug Interactions ( 7.1 )]. Inform patients that if they are going for any imaging tests while receiving Gallium-67 and deferoxamine mesylate for injection concomitantly it can result in reports with distorted images [see Drug Interactions ( 7.2 )]. Inform patients that their urine may occasionally show a reddish discoloration. Embryo-fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.10 ), Use in Specific Populations ( 8.1 , 8.3 )]. Advise females of reproductive potential to use effective contraceptive during treatment with deferoxamine mesylate for injection and for one month after the last dose [see Use in Specific Populations ( 8.3 )]. Lactation Advise patients to avoid breastfeeding while taking deferoxamine mesylate for injection and for one week after the final dose [see Use in Specific Populations ( 8.2 )]. Manufactured by: Gland Pharma Limited Hyderabad - 500043, India Manufactured for: Apotex Corp. Weston, FL USA 33326 Revised 03/2026
Package Label – 500 mg per vial Rx Only NDC 60505-6236-6 Deferoxamine mesylate for injection, USP 500 mg per vial Each vial contains Deferoxamine mesylate USP, 500 mg in lyophilized form. For subcutaneous intramuscular or intravenous administration. 4 vials Package Label – 2 g per vial Rx Only NDC 60505-6237-6 Deferoxamine mesylate for injection, USP 2 g per vial Each vial contains Deferoxamine mesylate USP, 2 g in lyophilized form. For subcutaneous intramuscular or intravenous administration. 4 vials
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