Iron Dextran (Monograph)

Brand names: Dexferrum, INFeD
Drug class: Iron Preparations
CAS number: 9004-66-4

Medically reviewed by Drugs.com on Oct 25, 2024. Written by ASHP.

Introduction

Ferric hydroxide¹⁰⁰ or ferric oxyhydroxide¹⁰¹ in a complex with partially hydrolyzed low molecular weight dextran.^{100 101}

Uses for Iron Dextran

Iron Deficiency Not Amenable to Oral Iron Therapy

Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used.^{100 101}

In patients with chronic kidney disease (CKD) on hemodialysis, IV iron superior to orally administered iron for increasing hemoglobin concentrations and/or minimizing dosage of an erythropoiesis-stimulating agent (ESA); the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines state that the IV route is preferred for iron administration in such patients.¹¹⁷

Iron Dextran Dosage and Administration

General

• Discontinue oral iron therapy prior to initiation of iron dextran therapy.^{100 101} (See Iron, oral under Interactions.)

• Calculate recommended total iron dextran dosage for treatment of iron deficiency anemia or iron replacement for blood loss from appropriate dosage formulas; these formulas are specific for each indication and are not interchangeable.^{100 101} Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturer’s labeling.^{100 101}

• Possible increased incidence of adverse effects, especially delayed reactions, associated with large IV doses of iron dextran, such as those used in total-dose infusions.^{100 101 104}

• Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy.^{100 101}

Sensitivity Testing

• Administer test dose by intended route of administration for therapeutic doses prior to initial therapeutic dose.^{100 101}

• After slow IV injection (given over ≥30 seconds for INFeD or ≥5 minutes for Dexferrum) or IM injection (INFeD) of 25 mg of iron (0.5 mL), observe for ≥1 hour for sensitivity reactions (see Anaphylaxis under Cautions) before administering the remaining portion of the initial dose.^{100 101}

• Take precautions to be prepared to treat potential allergic reactions.^{100 101} (See Boxed Warning.)

Administration

Administer undiluted by slow (≤50 mg/minute) IV injection;^{100 101} some preparations (i.e., INFeD) also are FDA-labeled for IM injection.¹⁰⁰ Iron dextran also has been administered after dilution by IV infusion^{† [off-label]} (e.g., over 1–6 hours).^{121 122 123}

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion.^{100 101}

Dilution

Dilution not recommended by manufacturers,^{100 101} but there have been reports of the total calculated dose of iron dextran being diluted in 250–1000 mL of 0.9% sodium chloride injection for IV infusion^{† [off-label]}.^{121 122 123}

Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis.^{a HID}

Rate of Administration

If undiluted, administer by slow IV injection at ≤50 mg/minute (1 mL/minute).^{100 101}

If diluted, administer by IV infusion^{† [off-label]} over 1–6 hours.^{121 122 123}

IM Administration

INFeD preparation: Administer by deep IM injection using a 2- or 3-inch, 19- or 20-gauge needle into the upper outer quadrant of the buttock only.¹⁰⁰

If patient is standing, administer IM injection in buttock of the leg opposite the patient’s weight-bearing leg; if supine, place patient in a lateral position with the injection site uppermost.¹⁰⁰

To avoid injection or leakage into subcutaneous tissue, use Z-track injection technique (i.e., firmly push aside subcutaneous tissue over the site of injection before inserting the needle).¹⁰⁰

Dosage

Available as iron dextran; dosage expressed in terms of elemental iron.^{100 101} Each mL of iron dextran injection is equivalent of 50 mg of elemental iron.^{100 101}

Pediatric Patients

Iron Deficiency Anemia

IV or IM

Children weighing 5–15 kg (11–33 lbs): Use the following formula (where Wt = patient's weight in kg and Hb_o = observed hemoglobin in g/dL):^{100 101}

[0.0442 × Wt × (12 g/dL - Hb_o)]+ (0.26 × Wt) = total dosage of iron dextran injection (mL)

Children weighing >15 kg (33 lbs): Use the following formula (where Wt = patient's weight in kg and Hb_o = observed hemoglobin in g/dL):^{100 101}

[0.0442 × Wt × (14.8 g/dL - Hb_o)]+ (0.26 × Wt) = total dosage of iron dextran injection (mL)

Iron Replacement Secondary to Blood Loss

IV or IM

Use the following formula to calculate required total iron dextran dosage in mL:^{100 101}

0.02 × blood loss (in mL) × hematocrit (expressed as a decimal fraction) = total dosage of iron dextran injection (mL)

Adults

Iron Deficiency Anemia

IV or IM

Recommended formula (where Wt = patient's weight in kg and Hb_o = observed hemoglobin in g/dL) for calculating total dosage of iron dextran injection (in mL):^{100 101}

[0.0442 × Wt × (14.8 g/dL - Hb_o)]+ (0.26 × Wt) = total dosage of iron dextran injection (mL)

Iron Replacement Secondary to Blood Loss

IV or IM

Use the following formula to calculate required total dosage of iron dextran injection (in mL):^{100 101}

0.02 × blood loss (in mL) × hematocrit (expressed as a decimal fraction) = total dosage of iron dextran injection (mL)

Prescribing Limits

Pediatric Patients

Iron Deficiency Not Amenable to Oral Iron Therapy

IV or IM

Infants weighing <5 kg (11 lbs): Maximum daily dosage is 25 mg of iron.^{100 101}

Children weighing 5–9 kg (11–21 lbs): Maximum daily dosage is 50 mg of iron.^{100 101}

Children weighing ≥10 kg (22 lbs): Maximum daily dosage is 100 mg of iron.^{100 101}

Adults

Iron Deficiency Not Amenable to Oral Iron Therapy

IV or IM

Maximum daily dosage is 100 mg of iron.^{100 101}

Special Populations

Renal Impairment

Iron Deficiency Not Amenable to Oral Iron Therapy

Anemia of Chronic Kidney Disease (CKD)

IV

In patients with CKD receiving an ESA, administer sufficient iron to maintain selected targets of iron therapy (i.e., transferrin saturation and serum ferritin concentrations); periodically monitor these iron indices and use results (in conjunction with hemoglobin concentrations and ESA dosage) to guide iron therapy.¹¹⁷

Cautions for Iron Dextran

Contraindications

• Anemias not associated with iron deficiency.^{100 101}

• Known hypersensitivity to iron dextran or any ingredient in the formulation.^{100 101}

Warnings/Precautions

Warnings

Anaphylactic-type Reactions

Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran.¹⁰¹ (See Anaphylaxis under Cautions.) Such reactions may be immediate or delayed.^{100 101 102 103 104 105 106 107}

Infectious Complications

Possible increased pathogenicity of certain microorganisms;^{110 111 112 113} not recommended for use during the acute phase of infectious renal disease.^{100 101}

Concomitant Cardiac Disorders

Possible exacerbation of cardiovascular complications because of adverse effects of the drug in patients with preexisting cardiovascular disease.^{100 101}

Carcinogenicity

Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes.^{100 101}

Sensitivity Reactions

Anaphylaxis

Manifested as sudden onset of respiratory difficulty (e.g., wheezing, bronchospasm, rigor, dyspnea, cyanosis), tachycardia, hypotension, respiratory arrest, and/or cardiovascular collapse; have resuscitation equipment and personnel trained in detection and treatment of anaphylactic-type reactions readily available during iron dextran administration.^{100 101 102 103 104} (See Boxed Warning.) Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely.^{100 101} (See Sensitivity Testing under Dosage and Administration.) Fatal reactions have occurred following test dose and also in patients in whom test dose was tolerated.¹⁰¹

Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors.¹⁰¹ Risk for anaphylactic-type reactions to specific iron dextran preparations is not known and may vary.^{100 101} Use with caution in patients with a history of clinically important allergies and/or asthma.^{100 101}

Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable.^{100 101}

General Precautions

Rheumatoid Arthritis

Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution.^{100 101}

Misuse

Excess storage of iron and a syndrome similar to hemosiderosis possible when used for anemia not attributable to iron deficiency (e.g., those with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias).^{100 101}

Specific Populations

Pregnancy

Category C.^{100 101}

Lactation

Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women.^{100 101}

Pediatric Use

Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age.^{100 101}

Hepatic Impairment

Use with extreme caution in patients with serious impairment of hepatic function.¹⁰⁰

Renal Impairment

Systemic exposure to iron dextran may be increased.^a (See Special Populations under Pharmacokinetics.)

Common Adverse Effects

Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity.^{100 101 102 103 104 105 106 107}

Drug Interactions

Specific Drugs and Laboratory Test Interactions

Iron Dextran Pharmacokinetics

Absorption

Bioavailability

Absorbed slowly from the site of IM injection, principally through the lymphatic system;^a 60% of an IM dose after 3 days, up to 90% after 1–3 weeks; and the remainder gradually absorbed over a period of several months or longer.^a

Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue.^a

Onset

In iron-deficient patients, reticulocytosis may begin by the 4th day following an IV infusion of the total calculated dose of iron dextran and reaches a maximum by about the 10th day.^a

Distribution

Extent

After reticuloendothelial cells separate iron from the iron dextran complex, iron becomes a part of the body’s total iron stores.¹²¹

Crosses the placenta and small amounts of iron apparently reach the fetus.¹⁰⁰

Distributed into breast milk, but only as trace amounts of unmetabolized iron dextran.¹⁰⁰

Elimination

Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body.^{100 101}

Elimination Route

Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran.^a

Half-life

In doses ≤500 mg, iron dextran plasma concentrations decrease exponentially with a half-life of about 6 hours.^a

Special Populations

In iron-deficient patients with coexistent end-stage renal disease and other clinical problems, the serum elimination half-life of iron averaged 58.9 hours (range: 9.4–87.4 hours) following IV administration of iron dextran.¹⁰¹

Negligibly removed by hemodialysis.^{101 115 116}

Stability

Storage

Parenteral

Injection

20–25°C; excursions permitted to 15–30°C.^{100 101}

Compatibility

Parenteral

Solution CompatibilityHID

Actions

• Corrects the erythropoietic abnormalities that are due to a deficiency of iron.^a

• Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency.^a

Advice to Patients

• Risk of anaphylactic reactions.^{100 101}

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{100 101}

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.^{100 101}

• Importance of informing patients of other important precautionary information.^{100 101} (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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