Injectafer (ferric carboxymaltose)

Injectafer is a prescription iron replacement medicine used to treat iron deficiency anemia (IDA) in adults who have:

• intolerance to oral iron or who have not responded well to treatment with oral iron, or
• non-dialysis dependent chronic kidney disease

It is not known if Injectafer is safe and effective for use in children.

Injectafer may cause serious side effects, including:

• Allergic (hypersensitivity) reactions. Serious life-threatening allergic reactions have happened in people who receive Injectafer. Other serious reactions including itching, hives, wheezing, and low blood pressure also have happened during treatment with Injectafer. Tell your healthcare provider if you have ever had any unusual or allergic reaction to any iron given by vein.
• High blood pressure (hypertension). High blood pressure, sometimes with face flushing, dizziness, or nausea, has happened during treatment with Injectafer. Your healthcare provider will check your blood pressure and check for any signs and symptoms of high blood pressure after you receive Injectafer.

The most common side effects of Injectafer include:

• nausea
• high blood pressure
• flushing
• low levels of phosphorous in your blood
• dizziness

These are not all the possible side effects of Injectafer.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Recommended Dosage

Recommended dosage 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 exceed 1500 mg of iron per course.

Recommended dosage 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.

Each mL of Injectafer contains 50 mg of elemental iron.

Preparation And Administration

Administer Injectafer intravenously, either as an undiluted slow intravenous push or by infusion. 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-dose only.

When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. 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.

Repeat Treatment Monitoring Safety Assessment

Injectafer treatment may be repeated if IDA reoccurs. Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.

No Information provided

Before receiving Injectafer, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if Injectafer will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Injectafer passes into your breast milk. It is unknown whether Injectafer would pose a risk to your baby.