Iron dextran (injection)
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.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- This drug should be administered only when resuscitation techniques and treatment of anaphylactic or anaphylactoid reactions are readily available.
Updated September 2016