Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
FERRIC CARBOXYMALTOSE (UNII: 6897GXD6OE) (FERRIC CATION - UNII:91O4LML611)
American Regent, Inc.
FERRIC CARBOXYMALTOSE
FERRIC CATION 50 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Injectafer 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 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. 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. Injectafer is contraindicated in patients with a history of hypersensitivity to Injectafer or any of its components [see Warnings and Precautions (5.1) ]. Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [ see Warnings and Precautions (5.1)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations ). Advise pregnant wome
Injectafer (ferric carboxymaltose injection) is a dark brown, non-transparent, sterile, aqueous solution. NDC 0517-0602-01 100 mg iron/2 mL Single-Dose Vial Individually Boxed NDC 0517-0650-01 750 mg iron/15 mL Single-Dose Vial Individually Boxed NDC 0517-0620-01 1,000 mg iron/20 mL Single-Dose Vial Individually Boxed 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). [See the USP controlled room temperature.] Do not freeze.
New Drug Application
INJECTAFER- FERRIC CARBOXYMALTOSE INJECTION INJECTION, SOLUTION AMERICAN REGENT, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE INJECTAFER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INJECTAFER. INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION), FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2013 RECENT MAJOR CHANGES Indications and Usage. (1) 05/2023 Dosage and Administration, Recommended Dosage. (2.1) 05/2023 Dosage and Administration, Repeat Treatment Monitoring Safety Assessment. (2.3) 05/2023 Warnings and Precautions, Symptomatic Hypophosphatemia (5.2) 05/2023 INDICATIONS AND USAGE Injectafer 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. (1) adult patients who have non-dialysis dependent chronic kidney disease. (1) • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. (1) DOSAGE AND ADMINISTRATION For patients weighing 50 kg or more, the recommended dosage is Injectafer 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 Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. (2.1) For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. (2.1) See Section 2.1, Table 1 for dosage in patients with iron deficiency and heart failure. (2.1) Injectafer treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. (2.3) DOSAGE FORMS AND STRENGTHS Injection: 50 mg/mL (3) 100 mg iron/2 mL single-dose vial 750 mg iron/15 mL single-dose vial 1,000 mg iron/20 mL sing Læs hele dokumentet