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Iron Dextran Complex

Pronunciation

(EYE ern DEKS tran KOM pleks)

Index Terms

  • High-Molecular-Weight Iron Dextran (DexFerrum)
  • Imferon
  • Iron Dextran
  • Low-Molecular-Weight Iron Dextran (INFeD)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection:

Dexferrum: 50 mg/mL (1 mL [DSC], 2 mL [DSC])

Infed: 50 mg/mL (2 mL)

Brand Names: U.S.

  • Dexferrum [DSC]
  • Infed

Pharmacologic Category

  • Iron Salt

Pharmacology

The released iron, from the plasma, eventually replenishes the depleted iron stores in the bone marrow where it is incorporated into hemoglobin

Absorption

IM: 60% absorbed after 3 days; 90% after 1 to 3 weeks, the balance is slowly absorbed over months

IV: Uptake of iron by the reticuloendothelial system appears to be constant at about 10 to 20 mg/hour

Excretion

Urine and feces via reticuloendothelial system

Onset of Action

Hematologic response to either oral or parenteral iron salts is essentially the same; red blood cell form and color changes within 3 to 10 days

Maximum effect: Peak reticulocytosis occurs in 5 to 10 days, and hemoglobin values increase within 2 to 4 weeks; serum ferritin peak: 7 to 9 days after IV dose

Half-Life Elimination

48 hours

Use: Labeled Indications

Iron deficiency: Treatment of iron deficiency in patients in whom oral administration is unsatisfactory or infeasible

Contraindications

Hypersensitivity to iron dextran or any component of the formulation; any anemia not associated with iron deficiency

Dosing: Adult

Note: A 0.5 mL test dose should be given prior to starting iron dextran therapy.

Iron-deficiency anemia: IM (INFeD), IV (Dexferrum, INFeD):

Dose (mL) = 0.0442 (desired hemoglobin - observed hemoglobin) x LBW + (0.26 x LBW)

Desired hemoglobin: Usually 14.8 g/dL

LBW = Lean body weight in kg

Iron replacement therapy for blood loss: (INFeD), IV (Dexferrum, INFeD): Replacement iron (mg) = blood loss (mL) x Hct

Maximum daily dosage: Manufacturer's labeling: Note: Replacement of larger estimated iron deficits may be achieved by serial administration of smaller incremental dosages. Daily dosages should be limited to 100 mg iron (2 mL)

Cancer-/chemotherapy-associated anemia: IV: Note: Use the iron-deficiency anemia equation for determining a calculated dose, when applicable.

Weekly administration (off-label dosing; INFed):

Weeks 1-3: Test dose of 25 mg (over 1-2 minutes), followed by 75 mg (bolus) once weekly

Weeks 4 and after: 100 mg over 5 minutes once weekly until the calculated dose is reached (Auerbach, 2004)

or

Week 1: Test dose of 25 mg (slow IV push), followed 1 hour later by 75 mg over 5 minutes

Weeks 2-10: 100 mg over 5 minutes once weekly for a total cumulative dose of 1000 mg (NCCN anemia guidelines v.2.2014)

Total dose infusion (off-label dosing; INFeD):

Test dose of 25 mg (over 1-2 minutes), followed 1 hour later by the balance of the calculated total dose mixed in 500 mL NS and infused at 175 mL/hour (Auerbach, 2004)

or

Test dose of 25 mg (slow IV push) followed 1 hour later by the balance of the total dose as a single infusion over several hours; if calculated dose exceeds 1000 mg, administer remaining dose in excess of 1000 mg after 4 weeks if inadequate hemoglobin response (NCCN anemia guidelines v.2.2014)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: A 0.5 mL test dose (0.25 mL in infants) should be given prior to starting iron dextran therapy.

Iron-deficiency anemia: IM (INFeD), IV (Dexferrum, INFeD):

Children 5-15 kg: Should not normally be given in the first 4 months of life:

Dose (mL) = 0.0442 (desired hemoglobin - observed hemoglobin) x W + (0.26 x W)

Desired hemoglobin: Usually 12 g/dL

W = Total body weight in kg

Children >15 kg: Refer to adult dosing.

Iron replacement therapy for blood loss: Refer to adult dosing.

Maximum daily dose:

Children <5 kg: 25 mg iron (0.5 mL)

Children 5-10 kg: 50 mg iron (1 mL)

Children ≥10 kg: Refer to adult dosing.

Dosing: Renal Impairment

Hemodialysis: Nondialyzable. No dosage adjustment provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Reconstitution

Solutions for infusion should be diluted in 250-1000 mL NS.

Administration

Note: A test dose should be given on the first day of therapy; patient should be observed for 1 hour for hypersensitivity reaction, then the remainder of the day’s dose (dose minus test dose) should be given. Resuscitation equipment, medication, and trained personnel should be available. An uneventful test dose does not ensure an anaphylactic-type reaction will not occur during administration of the therapeutic dose.

IM (INFeD): Use Z-track technique (displacement of the skin laterally prior to injection); injection should be deep into the upper outer quadrant of buttock; alternate buttocks with subsequent injections. Administer test dose at same recommended site using the same technique.

IV: Test dose should be given gradually over at least 30 seconds (INFeD) or 5 minutes (Dexferrum), or over 1-2 minutes (INFeD) for cancer-/chemotherapy-associated anemia (Auerbach, 2004). Subsequent dose(s) may be administered by IV bolus undiluted at a rate not to exceed 50 mg/minute (maximum 100 mg). For total dose infusion in patients with cancer-/chemotherapy-associated anemia (off-label dose): 1 hour after the test dose, administer the balance of the dose diluted in 500 mL NS and infuse at 175 mL/hour (Auerbach, 2004) or administer over several hours (NCCN Anemia guidelines v.2.2104). Avoid dilutions with dextrose (increased incidence of local pain and phlebitis).

Compatibility

Stable in D5W, NS.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

ACE Inhibitors: May enhance the adverse/toxic effect of Iron Dextran Complex. Specifically, patients receiving an ACE inhibitor may be at an increased risk for anaphylactic-type reactions. Management: Follow iron dextran recommendations closely regarding both having resuscitation equipment and trained personnel on-hand prior to iron dextran administration and the use of a test dose prior to the first therapeutic dose. Consider therapy modification

Dimercaprol: May enhance the nephrotoxic effect of Iron Salts. Avoid combination

Test Interactions

May cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Residual iron dextran may remain in reticuloendothelial cells; may affect accuracy of examination of bone marrow iron stores. Bone scans with 99m Tc-labeled bone seeking agents may show reduced bony uptake, marked renal activity, and excess blood pooling and soft tissue accumulation following IV iron dextran infusion or with high serum ferritin levels. Following IM iron dextran, bone scans with 99m Tc-diphosphonate may show dense activity in the buttocks.

Adverse Reactions

Frequency not defined. Adverse event risk is reported to be higher with the high-molecular-weight iron dextran formulation.

Cardiovascular: Bradycardia, cardiac arrhythmia, chest pain, chest tightness, flushing, hypertension, hypotension, shock, syncope, tachycardia

Central nervous system: Chills, disorientation, dizziness, headache, loss of consciousness, malaise, paresthesia, seizure, unresponsive to stimuli

Dermatologic: Diaphoresis, pruritus, skin rash, urticaria

Gastrointestinal: Abdominal pain, diarrhea, dysgeusia, nausea, vomiting

Genitourinary: Hematuria, urine discoloration

Hematologic & oncologic: Leukocytosis, lymphadenopathy, purpura

Hypersensitivity: Anaphylaxis (includes acute respiratory distress, circulatory shock)

Infection: Sterile abscess

Local: Injection site reaction (includes injection site cellulitis, inflammation at injection site, injection site phlebitis, local soreness/soreness at injection site, pain at injection site, swelling at injection site), local discoloration (at the site of intramuscular injection)

Neuromuscular & skeletal: Amyotrophy (with intramuscular injection), arthralgia, arthritis, back pain, exacerbation of arthritis, myalgia, weakness

Respiratory: Bronchospasm, cyanosis, dyspnea, wheezing

Miscellaneous: Fever, fibrosis (with intramuscular injection)

<1% (Limited to important or life-threatening): Angioedema, neoplasm (at former injection site)

ALERT: U.S. Boxed Warning

Anaphylactic-type reactions:

Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during iron dextran administration.

Administer a test dose of iron dextran prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic iron dextran dose. During all iron dextran 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 in which the test dose was tolerated.

Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran.

Appropriate use:

Use iron dextran only in patients in whom clinical and laboratory investigations have established an iron-deficient state not amenable to oral iron therapy.

Warnings/Precautions

Concerns related to adverse effects:

• Delayed reaction: Delayed (1-2 days) infusion reaction (including arthralgia, back pain, chills, dizziness, and fever) may occur with large doses (eg, total dose infusion) of IV iron dextran; usually subsides within 3-4 days. May also occur (less commonly) with IM administration; subsiding within 3-7 days.

• Hypersensitivity/anaphylactoid reactions: [U.S. Boxed Warning]: Deaths associated with parenteral administration following anaphylactic-type reactions have been reported (use only where resuscitation equipment and personnel are available). A test dose should be administered to all patients prior to the first therapeutic dose. Anaphylactic and other hypersensitivity reactions have occurred even in patients who tolerated the test dose; observe for anaphylactic reactions during any iron dextran administration; fatalities have occurred with the test dose. A history of drug allergy (including multiple drug allergies) and/or the concomitant use of an ACE inhibitor may increase the risk of anaphylactic-type reactions. Adverse events (including life-threatening) associated with iron dextran usually occur more with the high-molecular-weight formulation (Dexferrum), compared to low-molecular-weight (INFeD) (Chertow, 2006).

Disease-related concerns:

• Allergies/asthma: Use with caution in patients with a significant history of allergies or asthma.

• Cancer-associated anemia: In patients with cancer-related anemia (either due to cancer or chemotherapy-induced) requiring iron supplementation, the IV route is superior to oral therapy; IM administration is not recommended for parenteral iron supplementation.

• Cardiovascular disease: Use with caution in patients with pre-existing cardiovascular disease; iron dextran may exacerbate cardiovascular complications.

• Hepatic impairment: Use with extreme caution in patients with serious hepatic impairment.

• Renal disease/impairment: In patients with chronic kidney disease (CKD) requiring iron supplementation, the IV route is preferred for hemodialysis patients; either oral iron or IV iron may be used for nondialysis and peritoneal dialysis CKD patients. Avoid use during acute kidney infection.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may exacerbate joint pain and swelling.

Special populations:

• Elderly: Anemia in the elderly is often caused by “anemia of chronic disease” or associated with inflammation rather than blood loss. Iron stores are usually normal or increased, with a serum ferritin >50 ng/mL and a decreased total iron binding capacity. IV administration of iron dextran is often preferred over IM in the elderly secondary to a decreased muscle mass and the need for daily injections.

• Pediatric: Intramuscular iron dextran use in neonates may be associated with an increased incidence of gram-negative sepsis.

Dosage form specific issues:

• Product interchangeability: Iron dextran products differ in chemical characteristics. The high-molecular-weight formulation (Dexferrum) and the low-molecular-weight formulation (INFeD) are not clinically interchangeable.

Other warnings/precautions:

• Appropriate use: [U.S. Boxed Warning]: Use only in patients where the iron deficient state is not amenable to oral iron therapy. Discontinue oral iron prior to initiating parenteral iron therapy.

• Carcinogenicity: Intramuscular injections of iron-carbohydrate complexes may have a risk of delayed injection site tumor development.

• Iron overload: Exogenous hemosiderosis may result from excess iron stores; patients with refractory anemias and/or hemoglobinopathies may be prone to iron overload with unwarranted iron supplementation.

Monitoring Parameters

Hemoglobin, hematocrit, reticulocyte count, serum ferritin, serum iron, TIBC; monitor for anaphylaxis/hypersensitivity reaction (during test dose and therapeutic dose)

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. It is not known if iron dextran (as iron dextran) crosses the placenta. It is recommended that pregnant women meet the dietary requirements of iron with diet and/or supplements in order to prevent adverse events associated with iron deficiency anemia in pregnancy. Treatment of iron deficiency anemia in pregnant women is the same as in nonpregnant women and in most cases, oral iron preparations may be used. Except in severe cases of maternal anemia, the fetus achieves normal iron stores regardless of maternal concentrations.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site pain or irritation, diarrhea, headache, cramps, or change in taste. Have patient report immediately to prescriber angina, severe dizziness, passing out, severe nausea, severe vomiting, burning or numbness feeling, difficulty breathing, back pain, joint pain, chills, seizures, severe muscle pain, severe abdominal pain, shortness of breath, flushing, bradycardia, tachycardia, or arrhythmia (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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