Recommended Dosage

Recommended Dosage for Treatment of Iron Deficiency Anemia

​For patients weighing 50 kg or more, the recommended dosage is:

• ​Injectafer 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course.
• ​In adult patients, Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course.

​For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course.

Recommended Dosage in Patients with Iron Deficiency with Heart Failure

​See Table 1 for recommended dosage for treatment of iron deficiency in patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

Table 1: Recommended Dosage in Patients with Iron Deficiency with Heart Failure

​Administer a maintenance dose of 500 mg at 12, 24 and 36 weeks if serum ferritin <100 ng/mL or serum ferritin 100-300 ng/mL with transferrin saturation <20%. There are no data available to guide dosing beyond 36 weeks or with Hb ≥15 g/dL.

Preparation and Administration

Administer Injectafer intravenously, either as an undiluted slow intravenous push or by infusion. When administered via infusion, dilute up to 1,000 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 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 a single dose.

When administering Injectafer 500 or 750 mg as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. For Injectafer 1,000 mg, administer as a slow intravenous push over 15 minutes. 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.

Discard unused portion.

2.3 Repeat Treatment Monitoring Safety Assessment

​Injectafer treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. Check serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment or for any patient who receives a repeat course of treatment within three months [see Warnings and Precautions (5.2)]. Treat hypophosphatemia as medically indicated.