BETHESDA, MD 29 July 2013—FDA has approved the marketing of ferric carboxymaltose injection, or Injectafer, for the treatment of iron deficiency anemia in adults who need an alternative to oral iron supplements or have non-dialysis-dependent chronic kidney disease, American Regent Inc. announced July 26.
Up to 1500 mg of iron can be administered over the course of two treatment sessions, the company said.
The labeling for ferric carboxymaltose injection (PDF) recommends doses of 750 mg for patients weighing at least 50 kg and 15 mg/kg for patients weighing less. Each dose of the iron carbohydrate complex is to be given by i.v. push of the undiluted drug solution at the rate of 100 mg/min or by i.v. infusion of diluted drug solution over at least 15 minutes. Seven days must pass before administration of the second dose.
During the two major studies of the drug in adults with iron deficiency anemia, the most common adverse reactions were nausea, hypertension, hot flush, decrease in blood phosphorus concentration, and dizziness.
The labeling tells clinicians to monitor patients for signs and symptoms of hypersensitivity during the administration of ferric carboxymaltose injection and for at least 30 minutes afterward. Serious anaphylactic or anaphylactoid reactions occurred in 0.1% of the patients who received the drug during the major studies.
Injectafer will be supplied in 15-mL single-use vials, with each milliliter containing 50 mg of iron.
For i.v. infusion of a dose, the labeling recommends adding the drug solution to 250 mL or less of 0.9% Sodium Chloride Injection, USP, in an infusion bag. The final concentration should be 2–4 mg of iron per milliliter. Such a solution is stable for 72 hours at room temperature.
Injectafer, the labeling states, is a dark brown colloidal solution that can cause a long-lasting brown discoloration if extravasation were to occur.
American Regent is a subsidiary of Luitpold Pharmaceuticals Inc., part of the Daiichi Sankyo Group.
A company spokeswoman said Injectafer will be available from wholesalers starting the week of August 12.