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Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).
DOSAGE AND ADMINISTRATION
The recommended dose of Feraheme is an initial 510 mg intravenous injection followed by a second 510 mg intravenous injection 3 to 8 days later. Administer Feraheme as an undiluted intravenous injection delivered at a rate of up to 1 mL/sec (30 mg/sec). The dosage is expressed in terms of mg of elemental iron, with each mL of Feraheme containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second Feraheme injection. The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.
For patients receiving hemodialysis, administer Feraheme once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each Feraheme injection.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.
Dosage Forms and Strengths
Feraheme (30 mg/mL) is available for intravenous injection in single use vials. Each vial contains 510 mg of elemental iron in 17 mL.
Feraheme is available in single use vials in the following package sizes (Table 3).
Table 3: Feraheme Packaging Description
|NDC Code||Dose/Total volume per vial||Vials/Carton|
|NDC 59338-775-01||510 mg/17mL||1|
|NDC 59338-775-10||510 mg/17mL||10|
Stability and Storage
Store at controlled room temperature (20° to 25°C [68° to 77°F]). Excursions permitted to 15° -30°C (59°-86°F).
Manufactured and Distributed by: AMAG Pharmaceuticals, Inc. Lexington, MA 02421
Last reviewed on RxList: 8/5/2011
This monograph has been modified to include the generic and brand name in many instances.
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