Iron Dextran

Pronunciation: EYE-urn DEX-tran
Class: Iron product

Trade Names

Dexferrum
- Injection, solution 50 mg iron/mL (as dextran)

InFeD
- Injection, solution 50 mg iron/mL (as dextran)

Dexiron (Canada)
Infufer (Canada)

Pharmacology

Replenishes hemoglobin (Hgb) and depleted iron stores.

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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

Half-life ranged from 5 to 20 h; however, these values do not represent Cl of iron from the body. Iron is not easily eliminated from the body and the accumulation of iron can be toxic.

Onset

A few days.

Special Populations

Hemodialysis

Removal by dialysis is negligible.

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. IV test doses should be administered at a gradual rate over at least 30 sec ( InFeD ) or over at least 5 min ( Dexferrum ). Anaphylactic reactions occurring following iron dextran injection are usually evident within a few min; however, at least 1 h should elapse before the remainder of the therapeutic dose is given.

Iron Deficiency Anemia
Adults and Children older than 4 mo of age

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.

The total amount of iron dextran in mL required to treat the anemia and replenish iron stores may also be approximated as follows:

Adults and Children weighing more than 15 kg (33 lb)

Dose (mL) = 0.0442 (desired Hgb − observed Hgb) × LBW + (0.26 × LBW)

Desired Hgb = the target Hgb in g/dL

LBW = lean body weight in kg.

Children weighing 5 to 15 kg (11 to 33 lb)

Dose (mL) = 0.0442 (desired Hgb − observed Hgb) × W + (0.26 × W)

W = weight in kg

Iron Replacement for Blood Loss
Adults and Children older than 4 mo of age IM/IV

Determine dose with the following formula based on the approximation that 1 mL of normocytic, normochromic RBC contains 1 mg of elemental iron: mg iron = blood loss (mL) × Hct.

Each day's dose should not exceed 0.5 mL (25 mg of iron) for infants less than 5 kg (11 lb) or 1 mL (50 mg of iron) for children less than 10 kg (22 lb) or 2 mL (100 mg of 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 ( InFeD only) or IV administration only. Not for intradermal, subcutaneous, or intra-arterial administration.
  • Do not administer if particulate matter or discoloration is noted.
  • Do not mix with other IV medications or add to parenteral nutrition solutions for IV infusions.
IV injection
  • Administer undiluted solution slowly at a rate no greater than 1 mL/min (50 mg/min). Maximum dosage should not exceed 2 mL (100 mg) daily.
IM injection ( InFeD only)
  • 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.

Storage/Stability

Store vials at 68° to 77°F.

Drug Interactions

ACE inhibitors (eg, captopril)

The risk of adverse systemic reactions (eg, fever, arthralgia, hypotension) to iron dextran may be increased. If an interaction is suspected, discontinue one of the agents.

Chloramphenicol

Serum iron levels may be increased because of decreased iron Cl and erythropoiesis due to direct bone marrow toxicity from chloramphenicol. If bone marrow suppression occurs, choose an alternate antimicrobial agent. If chloramphenicol must be continued, monitor iron stores and adjust the iron regimen as needed to avoid iron overload.

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 99mTc-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 99mTc-labeled bone-seeking agents may show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.

Serum bilirubin

May cause falsely elevated values.

Serum calcium

May cause falsely decreased values.

Serum ferritin

Peaks approximately 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; shivering; shock; syncope; tachycardia.

CNS

Convulsions; disorientation; dizziness; headache; malaise; numbness; paresthesia; seizures; 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; backache; myalgia.

Respiratory

Bronchospasm; dyspnea; respiratory arrest; wheezing.

Miscellaneous

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

Precautions

Warnings

Anaphylactic-type reactions (sometimes fatal) have occurred with parenteral use of product. A test dose should be administered prior to the first therapeutic dose of iron dextran. Observe patients for signs and symptoms of anaphylactic-type reactions during all administrations of iron dextran. 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.

BP

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

Excreted.

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.

Total dose infusions

Large IV doses have been associated with increased incidence of adverse reactions. The adverse reactions are usually delayed 1 to 2 days after administration and symptoms usually subside within 3 to 4 days.

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 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: light-headedness; 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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