Ferric carboxymaltose injection: Iron replacement for IDA

New drug

FDA approved ferric carboxymaltose injection (Injectafer—Luitpold Pharmaceuticals), the first high-dose nondextran I.V. iron treatment for adult patients who either cannot tolerate or have not responded well to oral iron. It is also indicated for iron deficiency anemia (IDA) in adult patients with non–dialysis-dependent chronic kidney disease. 

An estimated 7.5 million people in the United States have IDA. A frequent complication in many gastrointestinal disease states and conditions, IDA affects up to one-third of patients with inflammatory bowel disease and up to 24% of patients who have undergone gastric bypass surgery. It is also prevalent in children and women, with more than 3 million U.S. women of childbearing age affected due to conditions such as heavy uterine bleeding, postpartum anemia, and pregnancy.

Previous drug therapies were limited to treating IDA in chronic kidney disease patients or required infusions over several hours or significant multiple dosing sessions, whereas a single dose of up to 750 mg of ferric carboxymaltose can be administered undiluted as an I.V. push injection at a rate of 100 mg/min or as an I.V. infusion over at least 15 minutes.

Safety, efficacy data

The safety and efficacy of ferric carboxymaltose injection were evaluated in two clinical trials that demonstrated the product’s improvement over a comparator. Trial 1 compared two 750-mg doses of ferric carboxymaltose injection with either oral or I.V. iron (standard of care therapy) in 1,000 patients with IDA, one-half of whom received ferric carboxymaltose injection. Ferric carboxymaltose injection raised hemoglobin more than did oral iron or I.V. standard of care therapy, and these increases were statistically significant. 

Trial 2, involving 2,561 high-risk patients, compared ferric carboxymaltose injection with iron sucrose injection (Venofer—American Regent); approximately one-half of the patients received ferric carboxymaltose injection. Two 750-mg doses of ferric carboxymaltose injection raised hemoglobin more than did five 200-mg doses of iron sucrose injection; these increases were also statistically significant. 

The most common adverse effects were nausea, hypertension, flushing/hot flush, blood phosphorus decrease, and dizziness. Serious adverse effects included severe hypersensitivity reactions, including life-threatening or fatal anaphylactic/anaphylactoid reactions  as well as pruritus, rash, urticaria, wheezing, and hypotension.

The entire Injectafer program—consisting of more than 11,071 patients treated with either the drug or a comparator—is the largest safety database ever submitted to FDA to support the approval of an I.V. iron product, according to the manufacturer. Outside of North America, the drug is manufactured and marketed under the name of Ferinject by Vifor Pharma.

Patient counseling

Review the Medication Guide with patients and warn them that serious or life-threatening allergic reactions have been reported with I.V. iron products. Advise patients to tell their health care provider if they have ever had any unusual or allergic reaction to any I.V. iron product and to report any signs and symptoms of an allergic reaction, in particular rashes, shortness of breath, and wheezing. 

Ferric carboxymaltose injection (Injectafer)

Manufacturer: Luitpold Pharmaceuticals

Indication: Treatment of iron deficiency anemia in adult patients who have intolerance to oral iron, have had unsatisfactory response to oral iron, or who have non–dialysis-dependent chronic kidney disease.  

Dosage: For patients weighing 50 kg (110 lb) or more: two 750-mg doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. For patients weighing less than 50 kg (110 lb): each dose as 15 mg/kg body weight separated by at least 7 days.

The drug should be administered intravenously by infusion over at least 15 minutes or by slow push injection at the rate of approximately 100 mg (2 mL) per minute over at least 7.5 minutes. Treatment may be repeated if iron deficiency anemia reoccurs.

Of note: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening or fatal, have been reported in patients receiving ferric carboxymaltose injection. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Patients should be monitored for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes and until clinically stable.