Rx Item-Feraheme 510Mg 17Ml Vial 17Ml By Amag Pharma

FERAHEME- ferumoxytol non-stoichiometric magnetite injection
AMAG Pharmaceuticals, Inc.

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Warnings and Precautions (5.1)].
Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration [see Warnings and Precautions (5.1)].
Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE



Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).

2 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 as an intravenous infusion in 50-200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Administer while the patient is in a reclined or semi-reclined position.

Feraheme, when added to intravenous infusion bags containing either 0.9% 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 infusion. 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 infusion.

? Allow at least 30 minutes between administration of Feraheme and administration of other medications that could potentially cause serious hypersensitivity reactions and/or hypotension, such as chemotherapeutic agents or monoclonal antibodies.

? Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.

3 DOSAGE FORMS AND STRENGTHS

? Feraheme Injection is available in single use vials. Each vial contains 510 mg of elemental iron in 17 mL (30 mg per mL).

RX ITEM-Feraheme 510Mg 17Ml Vial 17Ml By
NDC 59338-0775-01 UPC/GTIN No.3-59338-77501-3 Mfg.Part No.77501

Feraheme 510Mg 17Ml Vial 17Ml By Amag Ph
BRAND: FERAHEME NDC: 59338-0775-01,59338077501 UPC: 3-59338-77501-3,359338775013 Amag Pharmaceuticals, Inc.

FERUMOXYTOL INTRAVEN VIAL
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