Ferrlecit

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

The dosage of Ferrlecit is expressed in terms of mg of elemental iron. Each 5 mL sterile, single-use ampule or 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 [see ADVERSE REACTIONS].

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.

HOW SUPPLIED

Dosage Forms And Strengths

Ferrlecit is available as a single use ampule or vial, containing 62.5 mg of elemental iron in 5 mL volume.

Storage And Handling

NDC 0024-2791-50 for ampules
NDC 0024-2792-10 for vials

Ferrlecit is supplied in colorless glass ampules or vials. Each sterile, single-use ampule or vial contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in cartons of 10 ampules or 10 vials.

Storage

Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F). See USP Controlled Room Temperature. Do not freeze.

Keep out of the reach of children.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: August 2011

Last reviewed on RxList: 8/31/2011
This monograph has been modified to include the generic and brand name in many instances.

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