Ferric carboxymaltose

Ferric carboxymaltose injection is indicated for the treatment of: • Iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult 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. Ferric carboxymaltose injection is an iron replacement product indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult 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.

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

For patients weighing 50 kg or more, the recommended dosage is ferric carboxymaltose injection 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. For adult patients weighing 50 kg or more, an alternative dose of ferric carboxymaltose injection 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. ( 2. 2) For patients weighing less than 50 kg, the recommended dosage is ferric carboxymaltose injection 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. See Section 2.2, Table 1 for dosage in patients with iron deficiency and heart failure. ( 2. 2) Ferric carboxymaltose injection treatment may be repeated if IDA or iron deficiency in heart failure reoccurs.

Ferric carboxymaltose injection is contraindicated in patients with a history of hypersensitivity to ferric carboxymaltose injection or any of its components. Hypersensitivity to ferric carboxymaltose injection or any of its inactive components.

Boxed warning (symptomatic hypophosphatemia • ferric carboxymaltose injection): can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention. • Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia. Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after ferric carboxymaltose injection administration for at least 30 minutes and until clinically stable following completion of each administration. ( 5. 2) Hypertension: Monitor patients closely for signs and symptoms of hypertension following each ferric carboxymaltose injection administration.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Symptomatic Hypophosphatemia Hypersensitivity Reactions Hypertension Laboratory Test Alterations The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness. The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze.