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) f or intravenous use
Initial U.S. Approval: 2013
INDICATIONS AND USAGE
Injectafer is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients:
who have intolerance to oral iron or have had unsatisfactory response to oral iron;
who have non-dialysis dependent chronic kidney disease. (1)
DOSAGE AND ADMINISTRATION
For patients weighing 50 kg (110 lb) or more:  Give Injectafer in two doses separated by at least 7 days.  Give each dose as 750 mg for a total cumulative dose of 1500 mg of iron per course.
For patients weighing less than 50 kg (110 lb):  Give Injectafer in two doses separated by at least 7 days and give each dose as 15 mg/kg body weight.
Injectafer treatment may be repeated if iron deficiency anemia reoccurs. (2)
DOSAGE FORMS AND STRENGTHS
Injection: 750 mg iron/15 mL single-dose vial. (3)
CONTRAINDICATIONS
Hypersensitivity to Injectafer or any of its inactive components. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions:  Observe for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of each administration. (5.1)
Hypertension:  Monitor patients closely for signs and symptoms of hypertension following each Injectafer administration. (5.2)
ADVERSE REACTIONS
The most common adverse reactions (≥ 2%) are nausea, hypertension, flushing, hypophosphatemia, and dizziness. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact American Regent at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Monitor breastfed infants for gastrointestinal toxicity. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Hypertension
5.3 Laboratory Test Alterations
6 ADVERSE REACTIONS
6.1 Adverse Reactions in Clinical Trials
6.2 Post-marketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis and Mutagenesis and Impairment of Fertility
14 CLINICAL STUDIES
14.1 Trial 1: Iron Deficiency Anemia in Patients Who Are Intolerant to Oral Iron or Have Had Unsatisfactory Response to Oral Iron
14.2 Trial 2: Iron Deficiency Anemia in Patients with Non-Dialysis Dependent Chronic Kidney Disease
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
Injectafer is indicated for the treatment of iron deficiency anemia in adult patients:
who have intolerance to oral iron or have had unsatisfactory response