Deferoxamine mesylate 500 mg/1
Deferoxamine mesylate · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Gland Pharma Limited
Deferoxamine mesylate is an injectable medication used to treat iron overload in the body, a condition that can occur from repeated blood transfusions or certain blood disorders. It works by binding to excess iron so your body can eliminate it through urine.
Key Facts
- Brand Name
- Deferoxamine mesylate
- Generic Name
- Deferoxamine mesylate
- NDC Code (Product)
68083-172- Manufacturer
- Gland Pharma Limited
- Strength
- 500 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA207384
- Marketing Start
- 10/09/2017
Recall History
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Pfizer Inc.
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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). 1.1 Acute Iron Intoxication Deferoxamine mesylate for injection is indicated as an adjunct to standard measures for the treatment of acute iron intoxication. 1.2 Chronic Iron Overload Deferoxamine mesylate for injection is indicated for the treatment of transfusional iron overload in patients with chronic anemia. 1.3 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 & Administration
2 DOSAGE AND ADMINISTRATION 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 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 m…
Contraindications
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 )] . • 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 )
Drug 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.
Adverse Reactions
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 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/medwat…
Frequently Asked Questions
What is Deferoxamine mesylate used for?
Deferoxamine mesylate is an injectable medication used to treat iron overload in the body, a condition that can occur from repeated blood transfusions or certain blood disorders. It works by binding to excess iron so your body can eliminate it through urine.
Is Deferoxamine mesylate a controlled substance?
Deferoxamine mesylate is not classified as a controlled substance by the DEA.
What is the generic name for Deferoxamine mesylate?
The generic name for Deferoxamine mesylate is Deferoxamine mesylate. There are 5 other brand versions of Deferoxamine mesylate.
What is the NDC code for Deferoxamine mesylate 500 mg/1?
The NDC (National Drug Code) for Deferoxamine mesylate 500 mg/1 is 68083-172, listed by Gland Pharma Limited.