Ferric carboxymaltose

These cases have occurred after single and multiple doses of ferric carboxymaltose injection. Risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome).

Preparation and Administration Administer ferric carboxymaltose injection 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, ferric carboxymaltose injection 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 injection is intended for a single dose. When administering ferric carboxymaltose injection 500 or 750 mg as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute.

For ferric carboxymaltose injection 1,000 mg, administer as a slow intravenous push over 15 minutes. Avoid extravasation of ferric carboxymaltose injection since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the ferric carboxymaltose injection administration at that site.

Discard unused portion.