Risk of Anaphylactic Type Reactions

Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection.

• Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Dexferrum administration.
• Administer a test Dexferrum dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Dexferrum dose.
• During all Dexferrum administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have followed the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated.
• Use Dexferrum only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy.
• Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to Dexferrum.