Drug Detail:Ferric carboxymaltose (Ferric carboxymaltose [ fer-ik-kar-box-ee-mawl-tose ])
Drug Class: Iron products
Usual Adult Dose for Iron Deficiency Anemia
Patients weighing 50 kg or more:
- Two doses of 750 mg via slow IV push or infusion separated by at least 7 days
- An alternative dose of 15 mg/kg to a maximum of 1,000 mg may be administered as a single-dose treatment course.
Patients weighing less than 50 kg:
- Two doses of 15 mg/kg via slow IV push or infusion separated by at least 7 days
Comments:
- Each mL of this drug contains 50 mg of elemental iron. The dosage is expressed in mg of elemental iron.
- Treatment may be repeated if iron deficiency anemia recurs.
Use: Treatment of iron deficiency anemia in adults with an intolerance or unsatisfactory response to oral iron and in adults with non-dialysis dependent chronic kidney disease
Usual Pediatric Dose for Iron Deficiency Anemia
Patients weighing 50 kg or more:
- Two doses of 750 mg via slow IV push or infusion separated by at least 7 days
- An alternative dose of 15 mg/kg to a maximum of 1,000 mg may be administered as a single-dose treatment course.
Patients weighing less than 50 kg:
- Two doses of 15 mg/kg via slow IV push or infusion separated by at least 7 days
Comments:
- The dosage is expressed in mg of elemental iron.
- Treatment may be repeated if iron deficiency anemia recurs.
Use: Treatment of iron deficiency anemia in pediatric patients 1 year and older with normal kidney function and with an intolerance to oral iron or an established unsatisfactory response to oral iron.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides
CONTRAINDICATIONS:
- Hypersensitivity to any of the ingredients
Safety and efficacy have not been established in patients 1 year old or younger with iron deficiency anemia.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Administer either as an undiluted slow IV push or by infusion over at least 15 minutes
- The concentration of the infusion should not be less than 2 mg of iron per mL (refer to manufacturer's preparation instructions).
- Each vial is intended for a single dose. Discard any unused portion.
- Inspect visually for the absence of particulate matter and discoloration prior to administration. This product contains no preservatives.
- When administering as a slow IV push give at a rate of 100 mg per minute.
- Monitor for extravasation, and if it occurs, discontinue administration at that site.
- Treatment may be repeated if iron deficiency anemia reoccurs.
- Excessive dosages may lead to accumulation of iron in storage sites potentially leading to hemosiderosis.
Storage requirements: Solutions diluted in 0.9% sodium chloride to a concentration of 2 to 4 mg/mL of elemental iron are stable for 72 hours when stored at room temperature.
IV compatibility: The manufacturer product information should be consulted; an IV solution for infusion should only be made using 0.9% sodium chloride.
General monitoring:
- Hypersensitivity: Monitor signs and symptoms of hypersensitivity reactions during and following ferric carboxymaltose administration.
- Hypophosphatemia: Monitor serum phosphate levels in patients at risk of low serum phosphate who require a repeat course of treatment.
General:
- Each mL of ferric carboxymaltose injection contains 50 mg of elemental iron
Patient advice
- Read the Patient Information and Instructions for Use.
Frequently asked questions
- How long does it take for Injectafer to work, when will I feel better?
