Treatment of Iron Deficiency
Oral iron supplements usually contain iron in the form of ferrous salts, such as
ferrous sulfate, ferrous gluconate, and ferrous fumarate.
These oral supplements are the mainstay of treatment for iron deficiency anemia.
However, the oxidation of these compounds in the lumen of the gut or within the
mucosa leads to the release of activated hydroxyl radicals, which attack the gut
wall and can result in gastrointestinal (GI) side effects, including nausea and
diarrhea. Such uncomfortable symptoms can lead to patient
noncompliance. In addition, in cases where iron deficiency anemia is severe and
blood loss is ongoing, such as in hemodialysis patients or patients with gastrointestinal
bleeding, the iron requirements may be too great to be corrected adequately with
oral iron therapy.
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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.