Ferric Carboxymaltose (2 brand names, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: INTRAVENOUS.
Brand Names
- FERRIC CARBOXYMALTOSE
- INJECTAFER
Indications and Usage
Ferric carboxymaltose injection is indicated for the treatment of: •iron deficiency anemia (IDA) in: oadult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. oadult patients who have non-dialysis dependent chronic kidney disease. •iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
Contraindications
Ferric carboxymaltose injection is contraindicated in patients with a history of hypersensitivity to ferric carboxymaltose or any of its components [see Warnings and Precautions (5.1)].
Adverse Reactions
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: •Hypersensitivity Reactions [see Warnings and Precautions (5.1)] •Hypophosphatemia [see Warnings and Precautions (5.2)] •Hypertension [see Warnings and Precautions (5.3)] •Laboratory Test Alterations [see Warnings and Precautions (5.4)]
Mechanism of Action
Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.
Overdosage
Excessive dosages of ferric carboxymaltose may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. A patient who received ferric carboxymaltose 18,000 mg over 6 months developed hemosiderosis with multiple joint disorder, walking disability, and asthenia. In the postmarketing setting, hypophosphatemic osteomalacia has been reported in patients who have received repeated high-cumulative courses of ferric carboxymaltose.