Injectafer

INDICATIONS

Injectafer is indicated for the treatment of iron deficiency anemia in adult patients;

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron;
  • who have non-dialysis dependent chronic kidney disease.

DOSAGE AND ADMINISTRATION

For patients weighing 50 kg (110 lb) or more: Give Injectafer in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed1500 mg of iron per course.

For patients weighing less than 50 kg (110 lb): Give Injectafer in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Injectafer is expressed in mg of elemental iron. Each mL of Injectafer contains 50 mg of elemental iron. Injectafer treatment may be repeated if iron deficiency anemia reoccurs.

Administer Injectafer intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Injectafer is intended for single use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Injectafer since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Injectafer administration at that site.

HOW SUPPLIED

Dosage Forms And Strengths

750 mg iron / 15 mL single-use vial

Storage And Handling

NDC 0517-0650-01 750 mg iron/15 mL Single-Use Vial Individually boxed
NDC 0517-0650-02 750 mg iron/15 mL Single-Use Vial Packages of 2

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See the USP controlled room temperature]. Do not freeze.

Injectafer is manufactured under license from Vifor (International) Inc, Switzerland.

American, Regent, Inc., Shirley, NY 11967, IN0602. Rev. 7/13

Last reviewed on RxList: 8/7/2013
This monograph has been modified to include the generic and brand name in many instances.

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