Injectafer® (ferric carboxymaltose injection)

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
  • OR
  • who have non‑dialysis dependent chronic kidney disease

Injectafer® is contraindicated in patients with hypersensitivity to Injectafer® or any of its inactive components.

The first non-dextran IV iron for adult patients with iron deficiency anemia (IDA) of various etiologies.

IDA etiologies may include:

  • Non-dialysis dependent chronic kidney disease2
  • Heavy Uterine Bleeding3
  • Postpartum3
  • GI Disorders (e.g. IBD, celiac disease)3
  • Post-gastric bypass4
  • Cancer3,5
  • Heart failure6

Injectafer® has a unique product specific code: J1439






NDC 0517-0650-01 | J Code: J1439

For coding, reimbursement, and patient support information,
please call the IV Iron Hotline:

1-877-4-IV-IRON (1-877-448-4766)



INDICATIONS

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.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

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®.

ADVERSE REACTIONS

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.

Please see Full Prescribing Information

REFERENCE: 1. Injectafer® [package insert]. Shirley, NY: American Regent, Inc.; 2013. 2. Onken JE, Bregman DB, Harrington RA, et al. Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial. Nephrol Dial Transplant. 2014;29(4):833-42. 3. Onken, JE, Bregman DB, Harrington RA, et al. A multicenter, randomized, active-controlled study to investigate the efficacy and safety of ferric carboxymaltose in patients with iron deficiency anemia. Transfusion. 2014;54(2):306-15. 4. Malone M, Barish C, He A, Bregman D. Comparative review of the safety and efficacy of ferric carboxymaltose versus standard medical care for the treatment of iron deficiency anemia in bariatric and gastric surgery patients. Obes Surg. 2013;23(9):1413-20. 5. Data on file, Luitpold Pharmaceuticals, Inc., Shirley, NY. 6. Okonko DO, Mandal AK, Missouris CG, et al. Disordered iron homeostasis in chronic heart failure: prevalence, and relation to anemia, exercise capacity, and survival. J Am Coll Cardiol. 2011;58(12):1241-51.