Proven safety profile of iron dextran
- In a retrospective analysis of 841,252 doses, dyspnea, hypotension, and neurological
symptoms were the most common major adverse events (AEs)
- The most common minor AEs were nausea, vomiting, flushing, and pruritus1
- Available in 2-mL single-dose vials
- Each vial contains 100 mg elemental iron
- Infusion rate of up to 50 mg/min
- Test dose required (25 mg by slow IV push)
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INFeD is indicated in the treatment of patients with documented iron deficiency
in whom oral administration is unsatisfactory or impossible.
Important Safety Information
Anaphylactic-type reactions, including fatalities, have followed the parenteral
administration of iron dextran injection. A test dose should be administered prior
to the first therapeutic dose, followed by the full therapeutic dose if no signs
or symptoms of anaphylactic-type reactions are seen. Resuscitation equipment and
personnel trained in the detection and treatment of anaphylactic-type reactions
must be readily available during all INFeD administrations. Patients should be observed
for signs or symptoms of anaphylactic-type reactions during all INFeD administrations.
Fatal reactions have followed the test dose and have also occurred in situations
where the test dose was tolerated. Use INFeD 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. INFeD should
be used with caution in individuals with histories of significant allergies and/or
asthma, and is contraindicated in patients with hypersensitivity to the product
and patients with all anemias not associated with iron deficiency. INFeD should
be used with extreme care in patients with serious impairment of liver function,
and should not be used during the acute phase of infectious kidney disease. Unwarranted
therapy with parenteral iron will cause excess storage of iron with the consequent
possibility of exogenous hemosiderosis, which is particularly apt to occur in patients
with hemoglobinopathies and other refractory anemias.