INJECTAFER- ferric carboxymaltose injection injection, solution INJECTAFER- ferric carboxymaltose injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

FERRIC CARBOXYMALTOSE (UNII: 6897GXD6OE) (FERRIC CATION - UNII:91O4LML611)

Tilgjengelig fra:

American Regent, Inc.

INN (International Name):

FERRIC CARBOXYMALTOSE

Sammensetning:

FERRIC CATION 50 mg in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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.

Autorisasjon status:

New Drug Application

Preparatomtale

INJECTAFER- FERRIC CARBOXYMALTOSE INJECTION INJECTION, SOLUTION
AMERICAN REGENT, INC.
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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