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Parenteral Iron Supplementation
Available Products:
  • INFeD® (iron dextran) by Schein (only product approved for both IV & IM).
  • Dexferrum® (iron dextran) by American Regent.
  • Ferrlecit® (Na ferric gluconate complex) by Schein.
  • Venofer® (iron sucrose or iron saccharate complex) by American Regent.
  • Jectofer® (iron sorbitol; for IM use only) by Astra Pharmaceuticals. Available in Europe and Canada. It is not yet approved by the US FDA, and will not be discussed further.

Indications:

  1. Iron deficiency anemia, particularly in patients with end-stage renal disease undergoing hemodialysis and receiving epoetin therapy.
  2. Iron deficiency in patients for whom oral iron supplementation is ineffective.
  3. Iron replacement following significant blood loss.

Calculation of total iron deficit:

    Total iron deficit in adult patientsmay be estimated using one of the following equations (note: Hbt = target Hb level; Hbo = observed or actual Hb level; Bwt = body weight; for obese pts, use lean body wt.)
  • Total Dose (mg) = 50 { 0.0442 Bwt (Hbt - Hbo) + (0.26 Bwt) }
  • Total Dose (mg) = 2.4 Bwt (15 - Hbo) + 500
  • Most adult patients require a cumulative dose of elemental Fe of at least one gram.

Contraindications and Precautions:

  • Parenteral iron supplementation is ineffective in aplastic or hypoplastic anemia and acute leukemia.
  • Parenteral iron supplementation is contraindicated in early pregnancy, in patients with liver disease or acute renal failure.
  • IV iron products must be used with caution to minimize acute adverse reactions. An anaphylaxis management kit should be at hand.
  • Conservative estimates of iron deficit should be used to avoid iron overload.
  • Measures of iron status (ferritin, total iron binding capacity, & transferrin saturation) and red blood cell indices must be checked periodically to reevaluate the patient's need for additional iron supplementation. Parenteral iron should not be administered to patients with ferritin > 800 ng/mL or transferrin saturation > 50%. The flowchart below summaries a simple approach to iron supplementation in dialysis patients (see Fishbane and Wagner AJKD 2001; 37:879-83).

ProductAdministrationSide Effects
Iron dextran
InFed®
Dexferrum®

  • Iron dextran injection, USP. Dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran.
  • Apparent molecular size of the complex is 165 kD.
  • Each mL contains 50 mg of elemental Fe (as an iron dextran complex.)

    Available as 50 mg/mL, 2-mL and 1-mL vials.

  • A test dose (25 mg Fe) is required for 1st exposure. This should be diluted in 50-100 mL of NS and infused over 15-20 minutes.
  • Monitor HR, RR, & BP q15 min for 1-2 hrs after test dose is started.
  • The total Fe deficit (dose) is estimated using one of the equations cited above, and can either be administered as one large dose (diluted in 500-1000 mL NS and infused over 4 to 8 hrs) or divided into many smaller doses given 1-3 times per week. Each 100-mg dose may be administered undiluted as iv push (max rate = 20 mg Fe per minute for Dexferrum and 50 mg per min for Infed.) Alternatively, each 100-mg dose is diluted in 250 mL NS and infused over 30-60 min.
  • Iron dextran is not to be mixed with any other medication, and should only be diluted with NS.
  • All other IV infusions should be stopped during iron dextran infusion.
  • >10% of pts experience flushing, dizziness, fever, headache, pain, diaphoresis, nausea, vomiting, and metallic taste.
  • 1-10 % of pts experience hypotension, urticaria, phlebitis, diarrhea, and urine discoloration.
  • <1% of pts experience chills, arthralgia leukocytosis, and lymphadenopathy
  • <1% of pts experience acute systemic sensitivity reactions, anaphylactoid reaction or severe anaphylactic shock including cardiovascular collapse (w/ severe hypotension), angioedema, bronchospasm, laryngospasm, and respiratory distress.
  • Sodium Ferric Gluconate
    Ferrlecit®

  • A macromolecular complex of sodium ferric gluconate in an alkaline (pH=7.7-9.7) solution of 20% sucrose.
  • Apparent molecular wt = 289 to 440 kD.
  • It contains no ferrous ion (Fe++) and no dextran.
  • It contains benzyl alcohol (9 mg/mL).

    Available as: 12.5 mg/mL, 5-mL ampules (62.5 mg per ampule). [Requires filter needle]

  • No test dose is required.
  • Monitor HR, RR, & BP q15 min for 1-2 hrs after test dose is started.
  • The total Fe deficit (dose) is administered in small installments of 125 mg Fe or less. Each dose is diluted in 100 mL of NS and infused over 60 min.
  • May also be administered undiluted as a slow IV injection at a rate not exceeding 12.5 mg/min (1 mL/min).
  • Most HD patients require 1 gram of Fe over eight sequential dialysis sessions.
  • IV iron products are not to be mixed with other iv medications
  • >10% of pts experience hypotension and flushing
  • 1-10% severe hypotension, chest pain, hypertension, syncope, tachycardia, angina, MI, pulmonary edema, hypovolemia, peripheral edema, headache, fatigue, fever malaise, dizziness, paresthesia, insomnia, agitation, rash, pruritus, hyperkalemia / hypokalemia, hypoglycemia, , abdominal pain, N/V, diarrhea, dyspepsia, flatulence, UTI, back pain, myalgia, arthralgia, paresthesia, blurred vision, conjunctivitis, dyspnea, cough, pneumonia,
  • 3.4% of pts: Hypersensitivity reactions, rigors, chills, flu-like syndrome, and diaphoresis.
  • <1% Epigastric pain, groin pain
  • Iron Sucrose
    Venofer®

  • Iron sucrose is also known as iron saccharate and described as polynuclear iron (III) hydroxide sucrose complex.
  • Apparent mol wt ranges from 34 to 60 kD

    Available as: 20 mg/mL, 5-mL vials (100 mg per vial).

  • No test dose is required.
  • Most patients require a total of 1 g Fe divided over 10 dialysis sessions (100 mg / session).
  • May be administered as iv push undiluted at the rate of 1 mL/min. " Each iv push dose should be limited to 100 mg. However, higher doses (200 mg) have been administered as iv push (over 10 min).
  • Should not exceed three doses per week.
  • Each 5-mL vial may be diluted in a maximum 100 mL NS (final concentration = 1 mg/mL) and administered over at least 20 minutes.
  • Doses as high as 500 mg have been infused in a single 2-hour session. This rate was associated with higher incidence of side effects such as nausea, hypotension, dizziness, and lower-back pain.
  • Doses of 200-300 mg infused over 2 hours have been used safely.
  • Venofer should not be mixed with other medications.
  • >20% of pts experience hypotension and cramps (23%).
  • >5% of pts experience nausea, headache, vomiting, and diarrhea
  • >1% of pts, fever, pain, asthenia, malaise, chest pain, hypertension, elevated liver enzymes, abdominal pain, dizzy, dyspnea, pneumonia, cough, pruritus, and application site reaction
  • Some pts experienced hypersensitivity reactions including anaphylactoid reaction.
  • References
    1. Product information inserts.
    2. Chandler G et al. Intravenous iron sucrose: establishing a safe dose. Am J Kidney Dis. 2001;38(5):988-91.
    3. Charytan C et al. Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Am J Kidney Dis. 2001;37(2):300-7.
    4. Prakash S et al. Experience with a large dose (500 mg) of intravenous iron dextran and iron saccharate in peritoneal dialysis patients. Perit Dial Int. 2001;21(3):290-5.
    5. Horl WH. Re: Experience with a large dose (500 mg) of intravenous iron dextran and iron saccharate in peritoneal dialysis patients. Perit Dial Int. 2001;21(5):527-8.
    6. MacDougall IC. Intravenous administration of iron in epoetin-treated haemodialysis patients--which drugs, which regimen? Nephrol Dial Transplant. 2000;15(11):1743-5.
    7. Eschbach JW. Current concepts of anemia management in chronic renal failure: impact of NKF-DOQI. Semin Nephrol. 2000;20(4):320-9.
    8. Van Wyck DB et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis. 2000;36(1):88-97.
    9. Silverberg DS et al Intravenous iron for the treatment of predialysis anemia. Kidney Int Suppl. 1999;69:S79-85.
    10. Johnson CA et al. Intravenous iron products. ANNA J. 1999;26(5):522-4.
    11. Gupta A. Pathogenesis of anaphylactoid reactions to intravenous iron. Am J Kidney Dis. 2000;35(2):360-1.
    12. Fishbane S, Magner J. Sodium ferric gluconate complex in the treatment of iron deficiency for patients on dialysis. Am J Kid Dis 2001; 37:870-83

     

     

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