The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that the use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before taking this drug.

Iron Dextran

Pronunciation: (iron DEX-tran)
Class: Iron product

Trade Names:
DexFerrum
- Injection 50 mg iron/mL (as dextran)

Trade Names:
InFeD
- Injection 50 mg iron/mL (as dextran)

Dexiron (Canada)
Infufer (Canada)

Pharmacology

Replenishes Hgb and depleted iron stores.

Pharmacokinetics

Absorption

Majority of IM injections are absorbed within 72 h, and most of the remaining iron is absorbed over 3 to 4 wk.

Distribution

90% or more is protein bound.

Metabolism

Removed from plasma by the reticuloendothelial system, which splits the drug into its components.

Elimination

Removal by dialysis is negligible.

Onset

A few days.

Indications and Usage

Treatment of iron deficiency anemia when oral administration of iron is unsatisfactory or impossible.

Unlabeled Uses

Use with epoetin to ensure hematological response to epoetin.

Contraindications

Anemia not associated with iron deficiency; hypersensitivity to the product.

Dosage and Administration

Test dose

IM/IV Prior to the first IV or IM iron dextran injection, give a 0.5 mL test dose by the same route, respectively. Anaphylactic reactions occurring following iron dextran injection are usually evident within a few minutes; however, at least 1 h should elapse before the remainder of the therapeutic dose is given.

Iron Deficiency Anemia
Adults and children

IM/IV For a table for determining requirement of Hgb restoration and iron stores replacement, refer to the product information. The accompanying formula is applicable for dosage determination only in patients with iron deficiency anemia and it is not to be used for dosage determination in patients requiring iron replacement for blood loss. Mg blood iron/lb body weight = mL blood/lb body weight × g Hgb/mL blood × mg iron/g Hgb

Factors contributing to the above formula are:

Blood volume is 65 mL/kg of body weight.
Normal Hgb: more than 15 kg (33 lb) is 14.8 g/dL; 15 kg (33 lb) or less is 12 g/dL.
Iron content of hemoglobin is 0.34%.
Hgb deficit.
Weight.

Iron Replacement for Blood Loss
Adults and children Test dose

IM/IV with dose based on formula that 1 mL of normocytic, normochromic RBC cells contains 1 mg of elemental iron (max, 2 mL/day undiluted iron dextran): Mg iron = blood loss (mL) × Hct

Each day's dose should not exceed 0.5 mL (25 mg iron) for infants less than 11 lb or 1 mL (50 mg iron) for children less than 22 lb or 2 mL (100 mg iron) for other patients.

General Advice

Discontinue oral iron preparations before administering parenteral iron products. Coadministration of parenteral iron preparations may reduce absorption of oral iron.
For IM or IV administration only. Not for intradermal, subcutaneous, or intra-arterial administration.

IV injection

Administer undiluted solution slowly at rate no greater than 1 mL/min (50 mg/min). Maximum dose should not exceed 2 mL (100 mg) daily.

IM injection

Change needles between withdrawal of iron dextran from vial and injection to minimize staining of subcutaneous tissues.
Inject prescribed dose deeply, using 2- or 3-inch 19- or 20-gauge needle, into the muscle of the upper outer quadrant of the buttock (never into the arm or other exposed areas). To avoid injection or leakage into subcutaneous tissue, administer using Z-track technique (displacement of skin laterally prior to injection).
If patient is standing, have patient bear weight on the leg opposite the injection site. If in bed, have patient in a lateral position with injection site uppermost.
Do not mix with other IV medications or add to parenteral nutrition solutions.
Do not administer if particulate matter or discoloration noted.
Store vials at controlled room temperature (59° to 86°F).

Storage/Stability

Store vials at controlled room temperature (59° to 86°F).

Drug Interactions

ACE inhibitors (eg, captopril)

Systemic adverse reactions to IV iron (eg, fever, arthralgia, hypotension) may occur.

Chloramphenicol

May increase serum iron concentrations.

Incompatibility

Do not mix with other medications or add to parenteral nutrition solutions for IV infusions.

Laboratory Test Interactions

Bone marrow exams

Because residual iron dextran may remain in the reticuloendothelial cells, bone marrow examinations for iron stores may not be meaningful for prolonged periods following iron dextran therapy. One to 6 days after IM iron dextran injections, bone scans involving 99m Tc-diphosphonate have shown a dense, crescentic area of activity in the buttocks that follows the contour of the iliac crest. In the presence of high serum ferritin levels or following iron dextran infusions, bone scans with 99m Tc-labeled bone seeking agents may show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.

Serum bilirubin

Drug may cause falsely elevated values.

Serum calcium

Drug may cause falsely decreased values.

Serum ferritin

Peaks about 7 to 9 days after IV iron dextran and slowly returns to baseline after about 3 wk.

Serum iron determinations

Especially by colorimetric assays, may not be meaningful for 3 wk after iron dextran administration.

Adverse Reactions

Cardiovascular

Arrhythmia; bradycardia; cardiac arrest; chest pain; chest tightness; hypertension; hypotension; shock; tachycardia.

CNS

Convulsions; disorientation; dizziness; headache; malaise; numbness; paresthesia; seizures; syncope; unconsciousness; unresponsiveness; weakness.

Dermatologic

Brown skin and/or underlying tissue discoloration (staining); cyanosis; flushing; pruritus; purpura; rash; sweating; urticaria.

GI

Abdominal pain; altered taste; diarrhea; nausea; vomiting.

Genitourinary

Hematuria.

Hematologic

Leukocytosis; lymphadenopathy.

Local

Atrophy/fibrosis at injection site; cellulitis; inflammation; local phlebitis; pain/soreness at or near IM injection site; sterile abscess; swelling.

Musculoskeletal

Arthralgia; arthritis; back pain; myalgia.

Respiratory

Bronchospasm; dyspnea; respiratory depression; wheezing.

Miscellaneous

Chills; delayed reactions (including arthralgia, backache, chills, dizziness, fever, headache, malaise, myalgia, nausea, vomiting); fatal anaphylaxis; febrile episodes; shivering.

Precautions

Warnings

Anaphylactic-type reactions (sometimes fatal) have occurred with parenteral use of product. Reserve for use only in patients with lab-confirmed iron deficiency who are unable to take oral iron.

Monitor

Baseline tests

Ensure Hgb, Hct, serum ferritin, and transferrin saturation are determined before starting therapy and periodically during treatment.

Monitor BP during infusion. If hypotension occurs, slow infusion rate. If hypotension continues, discontinue infusion and be prepared to treat appropriately.

Pregnancy

Category C .

Lactation

Use with caution. Traces of unmetabolized iron dextran are excreted in human milk.

Children

Not recommended in children younger than 4 mo of age.

Hypersensitivity

Hypersensitivity, including anaphylaxis, may occur. Have epinephrine immediately available.

Hepatic Function

Use drug with extreme caution in severe hepatic function impairment.

Allergies/Asthma

Use drug with caution in patients with history of significant allergies/asthma.

Arthritis

Patients with iron deficiency anemia and rheumatoid arthritis may have acute exacerbation of joint pain and swelling after IV administration.

CV disease

Adverse reactions of iron dextran may exacerbate CV complications in patients with preexisting CV disease.

Hemosiderosis

Unwarranted therapy with parenteral iron will cause excess storage of iron and possibly cause exogenous hemosiderosis, especially in patients with hemoglobinopathies and other refractory anemias.

Infectious kidney disease

Do not administer during acute phase of infectious kidney disease.

Overdosage

Symptoms

Hemosiderosis.

Patient Information

Advise patient that injectable iron is used when oral therapy has failed to produce a satisfactory response or if oral therapy is impossible.
Advise patient that medication will be prepared and administered by health care provider during dialysis sessions and that medication will not be administered at home.
Instruct patient to immediately inform health care provider if any of the following occur during, or shortly after, the administration of drug: lightheadedness; weakness; anxiety; sweating; rapid heart beat; shortness of breath or difficulty breathing; swelling of the throat; rash; itching; chest, back, flank, or groin pain.
Caution patient not to take oral iron supplements while receiving IV iron.

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