Injectafer® (ferric carboxymaltose injection)

For adult patients with iron deficiency anemia of various etiologies

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.

Etiologies of IDA may include

  • Cancer2
  • Gastrointestinal disorders1
  • Abnormal uterine bleeding1
  • Chronic kidney disease1

Injectafer® has a unique product specific code: Q9970






NDC 0517-0650-01 | Q Code: Q9970

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

877-4-IV-IRON



Injectafer® is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. The unique carbohydrate shell is tightly bound around the iron core which results in a more controlled slow release of iron. Because of its unique molecular structure, Injectafer® is designed to deliver a higher dose of iron in a shorter period of time with fewer administrations.



IMPORTANT SAFETY INFORMATION


INDICATIONS/CONTRAINDICATIONS


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.


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. 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.