FDA

Deferoxamine Mesylate

Approved 29 Sept 2017InjectionInjectable

The FDA lists this product in 10 strengths and forms.

Indications

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).

1.1Acute Iron Intoxication

Deferoxamine mesylate for injection is indicated as an adjunct to standard measures for the treatment of acute iron intoxication.

1.2Chronic Iron Overload

Deferoxamine mesylate for injection is indicated for the treatment of transfusional iron overload in patients with chronic anemia.

1.3Limitations 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).

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 )] .
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 )

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 )

At a glance

Brand name: Deferoxamine Mesylate
Route: Injection
Dosage form: Injectable
Applicant: Gland
Status: Prescription
FDA approval: 29 Sept 2017
Application: ANDA207384-002

Indications

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).

1.1Acute Iron Intoxication

Deferoxamine mesylate for injection is indicated as an adjunct to standard measures for the treatment of acute iron intoxication.

1.2Chronic Iron Overload

Deferoxamine mesylate for injection is indicated for the treatment of transfusional iron overload in patients with chronic anemia.

1.3Limitations 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).

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 )] .
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 )

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 )

Pregnancy and breastfeeding

8.1Pregnancy 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. Consider the benefits and risks of deferoxamine mesylate for the mother and possible risks to the fetus when prescribing deferoxamine mesylate to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal developmental study in mice, pregnant animals administered subcutaneous doses of deferoxamine at 180, and 540 mg/kg/day from gestation day 7 to gestation day 12 resulted in a dose dependent delay and irregularities of fetal skeletal maturation at doses ≥0.2 times the MRHD.

At the highest dose of 540 mg/kg, in 1/23 fetuses had a unilateral lesion to the eye lens (approximately 0.5 times the MRHD). In the embryo-fetal developmental studies in rabbits, pregnant animals administered subcutaneous doses of deferoxamine either 200 mg/kg or 200, 300, and 540 mg/kg from gestation day 6 to gestation day 14 resulted in maternal toxicity and embryo-fetal developmental effects at 0.7 times the MRHD.

Maternal toxicity included reduced fetal body weights and embryo-fetal effects included malformations of spina bifida, and increased incidence of abnormally ossified ribs and vertebrae. No maternal toxicity or embryo-fetal effects were observed in rats at deferoxamine doses tested (up to 0.9 times the MRHD).

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 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 Gland Pharma Limited at 866-770-7144 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

The following adverse reactions associated with the use of deferoxamine mesylate were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. At the Injection Site: Localized irritation, pain, burning, swelling, induration, infiltration, pruritus, erythema, wheal formation, eschar, crust, vesicles, local edema.

Injection site reactions may be associated with systemic allergic reactions ([see Body as a Whole, below)] Hypersensitivity Reactions and Systemic Allergic Reactions: Generalized rash, urticaria, anaphylactic reaction with or without shock, angioedema Body as a Whole: Local injection site reactions may be accompanied by systemic reactions like arthralgia, fever, headache, myalgia, nausea, vomiting, abdominal pain, or asthma Infections: Yersinia, mucormycosis Cardiovascular: Tachycardia, hypotension, shock Digestive: Abdominal discomfort, diarrhea, nausea, vomiting Hematologic: Blood dyscrasia (thrombocytopenia, leukopenia) Hepatic: Increased transaminases, hepatic dysfunction Musculoskeletal: Muscle spasms.

Growth retardation and bone changes (e.g., metaphyseal dysplasia) Nervous System: Neurological disturbances, including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias, seizures; exacerbation or precipitation of aluminum-related dialysis encephalopathy Special Senses: High-frequency sensorineural hearing loss, tinnitus, visual disturbances including acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts Respiratory: Acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates) Skin: Generalized rash Urogenital: Dysuria, acute renal failure, increased serum creatinine and renal tubular disorders

Deferoxamine Mesylate

Indications

1.1Acute Iron Intoxication

1.2Chronic Iron Overload

1.3Limitations of Use

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Deferoxamine Mesylate

Indications

1.1Acute Iron Intoxication

1.2Chronic Iron Overload

1.3Limitations of Use

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Hypersensitivity Reactions

5.2Auditory and Ocular Toxicity Ocular

5.3Renal Toxicity

5.4Respiratory Toxicity

5.5Growth Suppression

5.6Serious Infections Yersinia Infections

5.7Cardiac Dysfunction with Concomitant Use of Vitamin C

5.8Risks of Deferoxamine Mesylate Treatment in Patients with Aluminum Overload

5.9Effects on Ability to Drive and Use Machines

5.10Embryo-Fetal Toxicity Based

Interactions

7.1Prochlorperazine

7.2Gallium-67

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

Composition

Strengths and forms

Official product information