deferoxamine mesylate for injection, USP Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DEFEROXAMINE MESYLATE safely and effectively.
See full prescribing information for DEFEROXAMINE MESYLATE.

DEFEROXAMINE MESYLATE for injection, for intramuscular, intravenous, or subcutaneous use

Initial U.S. Approval: 1968

RECENT MAJOR CHANGES

Dosage and Administration, Preparation (2.3)

11/2023

INDICATIONS AND USAGE

Deferoxamine mesylate 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 is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).

DOSAGE AND ADMINISTRATION

Acute Iron Intoxication: (2.1)

Intramuscular Administration: Use for all 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.
Intravenous Administration: Only for patients in a state of cardiovascular collapse. Initial dose is 1,000 mg at a rate not to exceed 15 mg/kg/hr. Depending upon the clinical response, subsequent doses of 500 mg may be administered every 4 hours to 12 hours at a rate of up to 125 mg/hr. Maximum dose is 6,000 mg in 24 hours.

Chronic Iron Overload: (2.2)

Subcutaneous Infusion: Average daily dose is between 20 and 60 mg/kg. In patients with serum ferritin level below 2,000 ng/mL require about 25 mg/kg/day. Patients with serum ferritin level between 2,000 and 3,000 ng/mL require about 35 mg/kg/day. Patients with higher serum ferritin may require up to 55 mg/kg/day.
Intravenous Administration: 20 mg/kg/day to 40 mg/kg/day for pediatric patients and 40 mg/kg/day to 50 mg/kg/day over 8 hours to 12 hours in adults for 5 days to 7 days per week. In pediatric patients and adults, maximum dose should not exceed 40 mg/kg/day and 60 mg/kg/day, respectively.
Intramuscular Administration: 500 mg to maximum daily dose of 1,000 mg.

See Full Prescribing Information for instructions on preparation of Deferoxamine mesylate for administration. (2.3)

Vitamin C (up to 200 mg) increases availability of iron for chelation and may be given as an adjuvant to iron chelation therapy. (2.4)

DOSAGE FORMS AND STRENGTHS

For injection: 500 mg of deferoxamine mesylate as a lyophilized powder in single-dose fliptop vial for reconstitution. (3)

For injection: 2 g of deferoxamine mesylate as a lyophilized powder in single-dose fliptop vial for reconstitution. (3)

CONTRAINDICATIONS

Known hypersensitivity to the active substance. (4)
Patients with severe renal disease or anuria. (4)

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. (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 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. Avoid exceeding 200 mg daily in adults. Monitor cardiac function with combined treatment. (5.7)
Risks of Deferoxamine mesylate Treatment in Patients with Aluminum Overload: Risks include neurological dysfunction (including seizures), dialysis dementia, and aggravation of hyperparathyroidism. (5.8)
Effects on Ability to Drive and Use Machines: May cause dizziness. (5.9)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use effective contraception. (5.10, 8.1, 8.3)

ADVERSE REACTIONS

Most common adverse reactions are injection reactions (local and systemic), hypersensitivity reactions, infections with Yersinia and Mucormycosis, cardiovascular, gastrointestinal, hematologic, hepatic, musculoskeletal, urogenital, nervous, respiratory, ocular and hearing. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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)

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)
Geriatric Use: Increased risk of ocular disorders. (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DEFEROXAMINE MESYLATE safely and effectively.
See full prescribing information for DEFEROXAMINE MESYLATE.

DEFEROXAMINE MESYLATE for injection, for intramuscular, intravenous, or subcutaneous use

Initial U.S. Approval: 1968

RECENT MAJOR CHANGES

Dosage and Administration, Preparation (2.3)

11/2023

INDICATIONS AND USAGE

Deferoxamine mesylate 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 is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).

DOSAGE AND ADMINISTRATION

Acute Iron Intoxication: (2.1)

Intramuscular Administration: Use for all 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.
Intravenous Administration: Only for patients in a state of cardiovascular collapse. Initial dose is 1,000 mg at a rate not to exceed 15 mg/kg/hr. Depending upon the clinical response, subsequent doses of 500 mg may be administered every 4 hours to 12 hours at a rate of up to 125 mg/hr. Maximum dose is 6,000 mg in 24 hours.

Chronic Iron Overload: (2.2)

Subcutaneous Infusion: Average daily dose is between 20 and 60 mg/kg. In patients with serum ferritin level below 2,000 ng/mL require about 25 mg/kg/day. Patients with serum ferritin level between 2,000 and 3,000 ng/mL require about 35 mg/kg/day. Patients with higher serum ferritin may require up to 55 mg/kg/day.
Intravenous Administration: 20 mg/kg/day to 40 mg/kg/day for pediatric patients and 40 mg/kg/day to 50 mg/kg/day over 8 hours to 12 hours in adults for 5 days to 7 days per week. In pediatric patients and adults, maximum dose should not exceed 40 mg/kg/day and 60 mg/kg/day, respectively.
Intramuscular Administration: 500 mg to maximum daily dose of 1,000 mg.

See Full Prescribing Information for instructions on preparation of Deferoxamine mesylate for administration. (2.3)

Vitamin C (up to 200 mg) increases availability of iron for chelation and may be given as an adjuvant to iron chelation therapy. (2.4)

DOSAGE FORMS AND STRENGTHS

For injection: 500 mg of deferoxamine mesylate as a lyophilized powder in single-dose fliptop vial for reconstitution. (3)

For injection: 2 g of deferoxamine mesylate as a lyophilized powder in single-dose fliptop vial for reconstitution. (3)

CONTRAINDICATIONS

Known hypersensitivity to the active substance. (4)
Patients with severe renal disease or anuria. (4)

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. (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 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. Avoid exceeding 200 mg daily in adults. Monitor cardiac function with combined treatment. (5.7)
Risks of Deferoxamine mesylate Treatment in Patients with Aluminum Overload: Risks include neurological dysfunction (including seizures), dialysis dementia, and aggravation of hyperparathyroidism. (5.8)
Effects on Ability to Drive and Use Machines: May cause dizziness. (5.9)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use effective contraception. (5.10, 8.1, 8.3)

ADVERSE REACTIONS

Most common adverse reactions are injection reactions (local and systemic), hypersensitivity reactions, infections with Yersinia and Mucormycosis, cardiovascular, gastrointestinal, hematologic, hepatic, musculoskeletal, urogenital, nervous, respiratory, ocular and hearing. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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)

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)
Geriatric Use: Increased risk of ocular disorders. (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2023

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