What is Ferrlecit, and how does it work?

Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.

What are the side effects of Ferrlecit?

Common side effects of Ferrlecit include:

Tell your doctor if you have serious side effects of Ferrlecit including:

SLIDESHOW

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What is the dosage for Ferrlecit?

  • The dosage of Ferrlecit is expressed in terms of mg of elemental iron. Each 5 mL sterile, single-dose vial contains 62.5 mg of elemental iron (12.5 mg/mL).
  • Do not mix Ferrlecit with other medications or add to parenteral nutrition solutions for intravenous infusion.
  • The compatibility of Ferrlecit with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit. If diluted, use immediately.
  • Ferrlecit treatment may be repeated if iron deficiency reoccurs.

Adult Dosage And Administration

  • The recommended dosage of Ferrlecit for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of Ferrlecit (125 mg of elemental iron).
  • Ferrlecit may be diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour per dialysis session.
  • Ferrlecit may also be administered undiluted as a slow intravenous injection (at a rate of up to 12.5 mg/min) per dialysis session.
  • For repletion treatment most patients may require a cumulative dose of 1000 mg of elemental iron administered over 8 dialysis sessions.
  • Ferrlecit has been administered at sequential dialysis sessions by infusion or by slow intravenous injection during the dialysis session itself.
  • Data from Ferrlecit postmarketing spontaneous reports indicate that individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events.

Pediatric Dosage And Administration

  • The recommended pediatric dosage of Ferrlecit for the repletion treatment of iron deficiency in hemodialysis patients is 0.12 mL/kg Ferrlecit (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session.
  • The maximum dosage should not exceed 125 mg per dose.

What drugs interact with Ferrlecit?

  • Drug-drug interactions involving Ferrlecit have not been studied. Ferrlecit may reduce the absorption of concomitantly administered oral iron preparations.

Is Ferrlecit safe to use while pregnant or breastfeeding?

  • Parenteral iron administration may be associated with hypersensitivity reactions, which may have serious consequences, such as fetal bradycardia (see Clinical Considerations).
  • Available data from postmarketing reports with Ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage.
  • Ferrlecit contains benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant is unlikely.
  • However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs. Consider alternative iron replacement therapies without benzyl alcohol for use during lactation.

QUESTION

The only purpose of the kidneys is to filter blood. See Answer

Summary

Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Common side effects of Ferrlecit include nausea, vomiting, diarrhea, injection site reactions (pain, redness, swelling, or irritation), headache, cramps, high or low blood pressure, dizziness, general ill feeling (malaise), shortness of breath, chest pain, leg cramps and pain.

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Medically Reviewed on 12/18/2020
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All sections courtesy of the U.S. Food and Drug Administration