Desferal 500 mg/vial (Injection)

Indications

• Acute iron intoxication
• Chronic iron overload due to transfusion-dependent anemias
• Diagnosis of aluminum overload (Desferal) infusion test
• Chronic aluminum overload in patients with End-Stage Renal Failure (ESRF) under maintenance dialysis

Composition

• Deferoxamine mesylate (500 mg vials)
• 7.5 ml vial of white to practically white sterile lyophilized powder
• Medicinal ingredient deferoxamine mesylate (500 mg)
• Injection without non-medicinal ingredients
• Available in cartons of 10 vials

Pharmacology

• Deferoxamine binds trivalent (ferric) iron
• Forms ferrioxamine, a stable complex eliminated via the kidneys
• Capable of binding approximately 8.5 mg of trivalent (ferric) iron
• Binds to tissue-bound aluminum to form aluminoxamine, a stable, water-soluble complex
• Capable of binding approximately 4.1 mg of aluminum

Dosage & Administration

• Should only be given parenterally
• Dose should not exceed 6.0 grams in a twenty-four hour period
• Exerts a considerably greater effect when administered by continuous infusion
• Rapid intravenous injection exceeding 15 mg/kg/h may produce flushing, urticaria, hypotension and shock

Interaction

• Concomitant use of Prochlorperazine may lead to temporary impairment of consciousness
• Concomitant use of Vitamin C may enhance excretion of the iron complex in response to Desferal
• Concomitant use of Erythropoietin requires adjustment of erythropoietin dosage
• Regular monitoring of iron stores is important

Contraindications

• Hypersensitivity to deferoxamine mesylate or component of the container, except where desensitization is successful

Pregnancy & Lactation

• No adequate and well-controlled studies in pregnant women
• Reproductive toxicity observed in animal studies
• Risk to the fetus/mother is unknown
• Use in pregnant women only if hazard of acute iron intoxication is greater than potential teratogenic hazard
• Unknown passage into breast milk
• Consideration of abstaining from breast-feeding or using effective contraception

Precautions & Warnings

• Initiation and maintenance by physician experienced in treatment of chronic iron overload
• Adverse effects may be manifestations of underlying disease
• Keep out of reach of children
• Rapid intravenous injection exceeding 15 mg/kg/h may produce flushing, urticaria, hypotension and shock
• Vitamin C supplements should not be given to patients with cardiac failure

Overdose Effects

• Acute intoxication is unlikely to occur due to parenteral administration

Therapeutic Class

• Carboxylic acids and derivatives

Storage Conditions

• Store between 15-25°C
• Do not store above 25°C

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