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iron dextran injection, solution
----------Infed (Iron Dextran) 20 mg/mL Injection, USP 2 mL Single Dose Vial
WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS
• Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration.
• Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose.
• During all INFeD 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 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 reaction to INFeD.
INFeD (Iron Dextran Injection USP) is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. The pH of the solution is between 5.2 and 6.5.
Therapeutic Class: Hematinic
General: After intramuscular injection, iron dextran is absorbed from the injection site into the capillaries and the lymphatic system. Circulating iron dextran is removed from the plasma by cells of the reticuloendothelial system, which split the complex into its components of iron and dextran. The iron is immediately bound to the available protein moieties to form hemosiderin or ferritin,
Various studies involving intravenously administered 59Fe iron dextran to iron deficient subjects, some of whom had coexisting diseases, have yielded half-life values ranging from 5 hours to more than 20 hours. The 5-hour value was determined for 59Fe iron dextran from a study that used laboratory methods to separate the circulating 59Fe iron dextran from the transferrin-bound 59Fe. The 20-hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. It should be understood that these half-life values do not represent clearance of iron from the body. Iron is not easily eliminated from the body and accumulation of iron can be toxic.
In vitro studies have shown that removal of iron dextran by dialysis is negligible.1,2 Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux.
Indications and Usage
Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.
Risk for Anaphylactic-type Reactions: Anaphylactic-type reactions, including fatalities have followed the parenteral administration of iron dextran. Always have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Prior to the first therapeutic dose, administer a test INFeD dose of 0.5 mL. (See DOSAGE AND ADMINISTRATION.) Although reactions are usually evident within a few minutes, observe patients for at least one hour before administering the therapeutic dose. During all INFeD administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Fatal reactions have followed the test dose of iron dextran 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.
General: Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Therefore, administer a test dose prior to the first therapeutic dose of INFeD. (See BOXED WARNING and DOSAGE AND ADMINISTRATION: Administration.) 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.) Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Isoproterenol or similar beta-agonist agents may be required in these patients. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli.
Severe/Fatal: 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. (See BOXED WARNING and PRECAUTIONS: General, pertaining to immediate availability of epinephrine.)
Overdosage with iron dextran is unlikely to be associated with any acute manifestations. Dosages of iron dextran in excess of the requirements for restoration of hemoglobin and replenishment of iron stores may lead to hemosiderosis. Periodic monitoring of serum ferritin levels may be helpful in recognizing a deleterious progressive accumulation of iron resulting from impaired uptake of iron from the reticuloendothelial system in concurrent medical conditions such as chronic renal failure, Hodgkins disease, and rheumatoid arthritis. The LD50 of iron dextran is not less than 500 mg/kg in the mouse.
Dosage and Administration
Oral iron should be discontinued prior to administration of INFeD.
mg blood iron = mL blood x g hemoglobin x mg iron
1. Blood volume . . . . . . . . . . . . . . . .65 mL/kg of body weight
The total amount of INFeD in mL required to treat the anemia and replenish iron stores may be approximated as follows:
Adults and Children over 15 kg (33 lbs): See Dosage Table. Alternatively the total dose may be calculated:
Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW)
Based on: Desired Hb = the target Hb in g/dl.
Observed Hb = the patient’s current hemoglobin in g/dl.
LBW = Lean body weight in kg. A patient’s lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage.
For males: LBW = 50 kg + 2.3 kg for each inch of patient’s height over 5 feet
For females: LBW = 45.5 kg + 2.3 kg for each inch of patient’s height over 5 feet
To calculate a patient's weight in kg when lbs are known:
patient's weight in kilograms = weight in kilograms
Children 5 - 15 kg (11 - 33 lbs): See Dosage Table.
INFeD should not normally be given in the first four months of life. (See PRECAUTIONS: Pediatric Use.)
Alternatively the total dose may be calculated:
Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W)
Based on: Desired Hb = the target Hb in g/dl. (Normal Hb for Children 15 kg or less is 12 g/dl)
W = Weight in kg.
To calculate a patient's weight in kg when lbs are known:
patient's weight in kilograms = weight in kilograms
II. Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis. Such blood losses may occur periodically in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) and on a repetitive basis from procedures such as renal hemodialysis. Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. The table and formula described under I. Iron Deficiency Anemia are not applicable for simple iron replacement values. Quantitative estimates of the individual’s periodic blood loss and hematocrit during the bleeding episode provide a convenient method for the calculation of the required iron dose. The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron:
Replacement iron (in mg) = Blood loss (in mL) x hematocrit
Example: Blood loss of 500 mL with 20% hematocrit
Replacement Iron = 500 x 0.20 = 100 mg
INFeD dose = 100 mg = 2 mL
The total amount of INFeD required for the treatment of iron deficiency anemia or iron replacement for blood loss is determined from the table or appropriate formula. (See Dosage).
I. Intravenous Injection - PRIOR TO THE FIRST INTRAVENOUS INFeD THERAPEUTIC DOSE, ADMINISTER AN INTRAVENOUS TEST DOSE OF 0.5 ML. ADMINISTER THE TEST DOSE AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given. Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute.
2. Intramuscular Injection - PRIOR TO THE FIRST INTRAMUSCULAR INFeD THERAPEUTIC DOSE, ADMINISTER AN INTRAMUSCULAR TEST DOSE OF 0.5 ML. (See BOXED WARNING and PRECAUTIONS.) The test dose should be administered in the buttock using the same technique as described in the last paragraph of this section. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given. If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. Each day’s dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1.0 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2.0 mL (100 mg of iron) for other patients. INFeD should be injected only into the muscle mass of the upper outer quadrant of the buttock - never into the arm or other exposed areas - and should be injected deeply, with a 2-inch or 3-inch 19 or 20 gauge needle. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended.
NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
INFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (NDC 52544-931-02).
1. Hatton RC, Portales IT, Finlay A, Ross EA. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. Am J Kid Dis. 1995; 26(2):327-330.
Revised: September 2009
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Revised: 06/2011 General Injectables & Vaccines, Inc
Reproduced with permission of U.S. National Library of Medicine
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