*As of October 2017.
†For appropriate adult IDA patients (see Indications).
‡The INJECTAFER Savings Program is only available for adults 18 years or older who are commercially insured or cash-paying patients. It provides up to a maximum savings limit of $500 per dose and a $1000 program limit for coverage up to 2 doses. Insurance out of pocket must be over $50. Additional restrictions may apply. Please see full Terms and Conditions.
§For adult patients weighing less than 50 kg (110 lb), give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course of treatment.
Abbreviation: IDA, iron deficiency anemia.
Please see Important Safety Information below and full Prescribing Information for INJECTAFER at www.injectafer.com/pdf/pi.pdf.
INJECTAFER® (ferric carboxymaltose injection) is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) 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.
IMPORTANT SAFETY INFORMATION
INJECTAFER is contraindicated in patients with hypersensitivity to INJECTAFER or any of its inactive components.
WARNINGS AND PRECAUTIONS
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, and syncope.
To report adverse events, please contact American Regent at 1-800-734-9236. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
Please see Important Safety Information and full Prescribing Information for INJECTAFER at www.injectafer.com/pdf/pi.pdf.
References: 1. Koch TA, Myers J, Goodnough LT. Intravenous iron therapy in patients with iron deficiency anemia: dosing considerations. Anemia. 2015;2015:763576. doi:10.1155/2015/763576. 2. INJECTAFER [package insert]. Shirley, NY: American Regent, Inc; 2013.2. INJECTAFER [package insert]. Shirley, NY: American Regent, Inc; 2013.
American Regent® is a registered trademark of Luitpold Pharmaceuticals, Inc. Injectafer and the Injectafer logo are trademarks of Vifor (International), Inc., Switzerland. Injectafer is manufactured under license from Vifor (International), Inc., Switzerland. Trademarks not owned by Luitpold Pharmaceuticals, Inc., or Vifor (International) are the property of their respective owners.