Treatment of Iron Deficiency
Parenteral iron is used when iron requirements are too high to be corrected with
oral iron therapy (eg, gastrointestinal bleeding), when oral iron cannot be properly
absorbed (eg, after gastric bypass or in celiac disease), and in cases where oral
iron is not well tolerated because of gastrointestinal side effects and may lead
to noncompliance. IV iron dextran is the only parenteral
iron formulation indicated for the correction of iron deficiency in patients with
either normal or impaired renal function when oral iron use is unsatisfactory or
IV iron dextran
IV iron dextran therapy allows for FDA-approved treatment of a wide range of patients
with iron deficiency not amenable to iron therapy.
IV iron dextran is the only IV iron indicated in iron-deficient patients with normal
or impaired renal function. It is also effective in patients
with inflammatory conditions (eg, inflammatory bowel disease) who may be iron deficient
due to inadequate absorption, intestinal bleeding, or dietary restrictions.33
IV iron dextran has also been shown to be effective in increasing hemoglobin levels
in patients with chronic kidney disease on hemodialysis.
IV iron dextran has also been shown to improve the hemoglobin response to erythropoietic
therapy in patients with documented iron deficiency anemia coexisting with cancer.25
Low-Molecular-Weight and High-Molecular-Weight IV Iron Dextrans
Iron dextran products differ in chemical characteristics and may differ in clinical
effect and are therefore not clinically interchangeable. INFeD is the only low-molecular-weight
iron dextran. INFeD has a BP rating by the FDA and as such, the FDA has not approved
any therapeutically equivalent products to INFeD. The FDA's definition of a therapeutic
equivalent is a product that is pharmaceutically equivalent and is expected to have
the same safety and clinical profile when given to patients with conditions specified
in the product labeling.
Proven Safety 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 pruritus.
Serious adverse events are rare. In a nonuremic population, 3 serious adverse events
occurred in 481 patients (0.6%) receiving 2099 iron dextran injections (0.1%), with
no fatalities reported.
In a retrospective analysis of 61,950 hemodialysis patients, the incidence of reactions
requiring resuscitative medications was 0.0016% (7 episodes in 440,406 exposures).36
Anaphylactic reactions have been reported with the use of iron dextran injection;
on occasions these reactions have been fatal. Such reactions, which occur most often
within the first several minutes of administration, have been generally characterized
by sudden onset of respiratory difficulty and/or cardiovascular collapse. Because
fatal anaphylactic reactions have been reported after administration of iron dextran
injection, the drug should be given only when resuscitation techniques and treatment
of anaphylactic and anaphylactoid shock are readily available.
Anaphylaxis and other hypersensitivity reactions have been reported after uneventful
test doses as well as therapeutic doses of iron dextran injection. Therefore, a
test dose should be administered before the first therapeutic dose.
Epinephrine should be immediately available in the event of acute hypersensitivity
reactions. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular
injection.) Patients using beta-blocking agents may not respond adequately to epinephrine.
Isoproterenol or similar beta-agonist agents may be required in these patients.2
In a retrospective analysis of 841,252 doses, hypotension ranked as one of the most
major AEs along with dyspnea and neurological symptoms.
As listed in the INFeD® labeling, other cardiovascular
adverse reactions that can occur include chest pain, chest tightness, shock, cardiac
arrest, hypertension, tachycardia, bradycardia, flushing, and arrhythmias. Hypotension
and flushing may occur from too rapid injections by the intravenous route.
Fletes R, Lazarus JM, Gage J, Chertow GM. Suspected iron dextran-related adverse
drug events in hemodialysis patients. Am J Kidney Dis. 2001;37:743-749.
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INFeD is indicated in the treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.