Ferric Carboxymaltose 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 & Administration
For patients weighing 50 kg or more: Give Ferric Carboxymaltose 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.
For patients weighing less than 50 kg: Give Ferric Carboxymaltose 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 Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.
Administer Ferric Carboxymaltose 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, Ferric Carboxymaltose 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 Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.
Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.
Pregnancy & Lactation
Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.