Injectafer® is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients1
- who have intolerance to oral iron or have had unsatisfactory response to oral iron
- who have non‑dialysis dependent chronic kidney disease
Injectafer® is contraindicated in patients with hypersensitivity to Injectafer® or any of its inactive components.
Etiologies of IDA may include
- Gastrointestinal disorders1
- Abnormal uterine bleeding1
- Chronic kidney disease1
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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 have had
unsatisfactory response to oral iron, and in adult patients with non-dialysis dependent chronic kidney
disease. Injectafer® is contraindicated in patients with hypersensitivity to
Injectafer® or any of its inactive components.
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 were not limited to, pruritus, rash, urticaria, wheezing, or hypotension
were reported in 1.5% (26/1775) of these subjects.
In clinical studies, hypertension was reported in 3.8% (67/1775) of subjects. Transient elevations in systolic
blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of
subjects. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor
patients for signs and symptoms of hypertension following each Injectafer® administration.
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®.
In two randomized clinical studies, a total of 1775 patients were exposed to Injectafer®, 15 mg/kg of body weight,
up to a single maximum 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 ≥2% of Injectafer®-treated patients were nausea (7.2%); hypertension (3.8%);
flushing/hot flush (3.6%); blood phosphorus decrease (2.1%); and dizziness (2.0%).
The following serious adverse reactions have been most commonly reported from the post-marketing spontaneous reports:
urticaria, dyspnea, pruritus, tachycardia, erythema, pyrexia, chest discomfort, chills, angioedema, back pain, arthralgia,
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REFERENCE: 1. Injectafer® [package insert]. Shirley, NY: American Regent, Inc.; 2013. 2. Aapro M, Österborg A, Gascón P, Ludwig H, Beguin Y. Prevalence and management of cancer-related anaemia, iron deficiency and the specific role of i.v. iron. Ann Oncol. 2012;23(8):1954-1962.