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deferoxamine mesylate for injection, USP
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
deferoxamine mesylate for injection, USP Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Acute Iron Intoxication
Deferoxamine Mesylate for injection is indicated as an adjunct to standard measures for the treatment of acute...
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Dosage and 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...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
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 fliptop vial for reconstitution...
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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...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, have occurred in deferoxamine mesylate-treated...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- •
- Hypersensitivity Reactions [see...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Prochlorperazine
Concurrent treatment with deferoxamine mesylate and prochlorperazine, a phenothiazine derivative, may lead to temporary...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no available data on Deferoxamine mesylate use in pregnant...
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Overdosage
10 OVERDOSAGE
Acute Toxicity
Intravenous LD50s (mg/kg): mice, 287; rats, 329.
Inadvertent administration of an overdose or inadvertent intravenous bolus administration/rapid intravenous...
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Description
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 is supplied as...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Deferoxamine mesylate chelates iron by forming a stable complex that prevents the iron from entering into further...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies in animals have not been performed with...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Caution patients about the potential allergic reactions associated with rapid intravenous administration of Deferoxamine Mesylate for injection and the need for monitoring allergic...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.