Product Information

Description

Injectafer is indicated for the treatment of:.     iron deficiency anemia (IDA) in: 1 adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron., 2 adult patients who have non-dialysis dependent chronic kidney disease.

Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III)-hydroxide 4(R)-(poly-(1?4)-O-a-D-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate. It has a relative molecular weight of approximately 150,000 Da corresponding to the following empirical formula. [FeOx(OH)y(H2O)z]n [{(C6H10O5)m (C6H12O7)}l]k. where n ˜ 103, m ˜ 8, l ˜ 11, and k ˜ 4(l represents the mean branching degree of the ligand). The chemical structure is presented below. Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection.  Injectafer is available in 2 mL, 15 mL and 20 mL single-dose vials.  Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0. Vial closure is not made with natural rubber latex.