Deferoxamine mesylate (500 mg vials): Each 7.5 ml vial of white to practically white sterile lyophilized powder contains the medicinal ingredient deferoxamine mesylate (500 mg) for injection without non-medicinal ingredients. Available in cartons of 10 vials.

Deferoxamine Mesylate is indicated for:

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

Deferoxamine mesylate should only be given parenterally. The dose should not exceed 6.0 grams in a twenty-four hour period. Although Deferoxamine can be given by intramuscular injection, in most cases it exerts a considerably greater effect when administered by continuous infusion either intravenously (especially in cases of acute iron intoxication) or subcutaneously (especially in patients with chronic iron overload).

Rapid intravenous injection of Deferoxamine exceeding 15 mg/kg/h has produced flushing of the skin, urticaria, hypotension and shock

Patients who are hypersensitive to deferoxamine mesylate or component of the container, except where desensitization is successful.

Overdose Effects

Since Ddeferoxamine mesylate is available only for parenteral administration, acute intoxication is unlikely to occur.

Therapy with Deferoxamine should be initiated and maintained by physician experienced in the treatment of chronic iron overload due to blood transfusions. It should be noted that some of the signs and symptoms reported as adverse effects may in fact be manifestations of the underlying disease (iron and/or aluminum overload). As with all medicines, Deferoxamine should be kept out of reach of children. Rapid intravenous injection of Deferoxamine exceeding 15 mg/kg/h has produced flushing of the skin, urticaria, hypotension and shock 

Vitamin C supplements should not be given to patients with cardiac failure because impairment of cardiac function may be experienced in patients with severe chronic iron overload receiving combined treatment of Deferoxamine with high doses of vitamin C (more than 500 mg daily)

Pregnancy & Lactation

Pregnant Women: There are no adequate and well-controlled studies conducted in pregnant women.Studies in animals (rabbits) have shown reproductive toxicity. The risk to the fetus/mother is unknown. Women of childbearing potential with chronic iron and/or aluminum overload should not receive deferoxamine unless the use of an effective form of contraception, established before treatment, is continued throughout treatment and for at least the first month after treatment. During pregnancy, particularly in the first trimester, deferoxamine should only be used if the hazard of acute iron intoxication is considered to be greater than the potential teratogenic hazard of deferoxamine.

Nursing Women: It is not known whether deferoxamine mesylate passes into the breast milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse drug reactions in breast-fed newborns/infants, a decision should be made whether to abstain from breast-feeding or to abstain from using the medicinal product, taking into account the importance of the medicinal product to the mother.