"The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug ferumoxytol (Ferumoxytol, AMAG Pharmaceuticals), stating that even with current warnings, there have been 79 anaphylactic r"...
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 dose followed by a second 510 mg dose 3 to 8 days later. Administer Feraheme intravenously, either as an undiluted slow intravenous injection or by infusion.
|Administration||Rate of delivery||Dilution|
|Undiluted intravenous injection||1 mL/sec (30 mg/sec) At least 17 seconds||No Dilution|
|Diluted intravenous infusion||At least 15 minutes||Dilute in 50 to 200 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.|
Feraheme, when added to intravenous infusion bags containing either Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2-8 mg elemental iron per mL, should be used immediately, but may be stored at controlled room temperature (25°C ± 2°C) for up to 4 hours.
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 Injection is available in single use vials. Each vial contains 510 mg of elemental iron in 17 mL.
Storage And Handling
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/ 17 mL||1|
|NDC 59338-775-10||510 mg/ 17 mL||10|
Stability And Storage
Store at 20° to 25°C (68°to 77°F). Excursions permitted to 15°– 30°C (59°– 86°F) [see USP controlled room temperature].
Distributed by: AMAG Pharmaceuticals, Inc. Waltham, MA 02451. Revised: December 2013
Last reviewed on RxList: 4/7/2015
This monograph has been modified to include the generic and brand name in many instances.
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