BRIEF SUMMARY OF PRESCRIBING INFORMATION
INJECTAFER® (ferric carboxymaltose injection)
Rx Only
INDICATIONS AND USAGE: Injectafer (ferric carboxymaltose injection) is an iron replacement
product indicated for the treatment of iron deficiency anemia in adult patients:
• who have intolerance to oral iron or who have had unsatisfactory response to oral iron,
• who have non-dialysis dependent chronic kidney disease.
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 not to
exceed 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. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed
1500 mg of iron per course.
Injectafer treatment may be repeated if iron deficiency anemia reoccurs.
Administer Injectafer intravenously, either as an undiluted slow intravenous push or by infusion.
When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per
minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile
0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg
of iron per mL and administer over at least 15 minutes.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration
prior to administration. The product contains no preservatives. Injectafer is a single-use vial.
Discard unused portion.
Avoid extravasation of Injectafer since brown discoloration of the extravasation site may be long
lasting. Monitor for extravasation. If extravasation occurs, discontinue the Injectafer administration at
that site.
DOSAGE FORMS AND STRENGTHS: Single-use vials containing 50 mg elemental iron per mL in the
following presentation: 750 mg iron / 15 mL
CONTRAINDICATIONS: Hypersensitivity to Injectafer or any of its inactive components.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type
reactions, some of which have been life-threatening and fatal, have been reported in
patients receiving Injectafer. Patients may present with shock, clinically significant
hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and
symptoms of hypersensitivity during and after Injectafer administration for at least 30
minutes and until clinically stable following completion of the infusion. Only administer
Injectafer when personnel and therapies are immediately available for the treatment
of serious hypersensitivity reactions. In clinical trials, serious anaphylactic/anaphylactoid
reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer. Other serious or
severe adverse reactions potentially associated with hypersensitivity which included, but not
limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of
these subjects.
Hypertension: In clinical studies, hypertension was reported in 3.8% (67/1,775) of subjects in
clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial
flushing, dizziness, or nausea were observed in 6% (106/1,775) of subjects in these two clinical
trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes.
Monitor patients for signs and symptoms of hypertension following each Injectafer administration.
Laboratory Test Alterations: In the 24 hours following administration of Injectafer, laboratory
assays may overestimate serum iron and transferrin bound iron by also measuring the iron in
Injectafer.
ADVERSE REACTIONS
Adverse Reactions in Clinical Trials: Because clinical trials are conducted under widely varying
conditions, the adverse reaction rates observed cannot be directly compared to rates in other
clinical trials and may not reflect the rates observed in clinical practice.
In two randomized clinical studies, a total of 1,775 patients were exposed to Injectafer 15 mg/kg body
weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days
up to a cumulative dose of 1500 mg of iron.
Adverse reactions reported by ≥ 1% of treated patients are shown in the following table.
Table 1. Adverse reactions reported in ≥ 1% of Study Patients in Clinical Trials 1 and 2
Pooled
Injectafer
Compar