Making the Case for INFeD

Treatment of Iron Deficiency

Parenteral iron

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.4 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 not possible.2

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.2

IV iron dextran is the only IV iron indicated in iron-deficient patients with normal or impaired renal function.2 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.34

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.2 INFeD is the only low-molecular-weight iron dextran. INFeD has a BP rating37 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.37

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).1 The most common minor AEs were nausea, vomiting, flushing, and pruritus.1

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.35

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

Anaphylaxis

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.2

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.2

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

Hypotension

In a retrospective analysis of 841,252 doses, hypotension ranked as one of the most major AEs along with dyspnea and neurological symptoms.1

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.2

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.