Thursday, June 8, 2023
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In the United States, the estimated prevalence of iron-deficiency anemia (IDA) is 7.5 million. Before the US Food and Drug Administration (FDA) approved ferric carboxymaltose injection to treat IDA, available treatments mostly targeted IDA in patients with chronic kidney disease. Other available treatments were administered as infusions during the course of several hours or had to be given in multiple dosing sessions.
The newly approved injection is the first high-dose, nondextran intravenous iron approved in the United States to treat IDA in a broad patient population. It is currently registered in 46 countries and marketed in 37 countries worldwide.
The FDA has approved ferric carboxymaltose injection (Injectafer) for the treatment of IDA in adults who either cannot tolerate or have not responded well to oral iron.
The ferric carboxymaltose injection is also indicated for the treatment of IDA in adult patients with nondialysis-dependent chronic kidney disease.
The injection is the first high-dose, nondextran intravenous iron indicated for a "broad patient population" with IDA.
An estimated 7.5 million people in the United States have IDA. Current therapies are either limited to treating IDA in patients with chronic kidney disease and/or require infusions during the course of several hours or significant multiple dosing sessions.
With ferric carboxymaltose injection, a single dose of up to 750 mg can be administered undiluted as an intravenous push injection at a rate of 100 mg/minute or as an intravenous infusion in up to 250 mL of 0.9% sodium chloride injection during the course of at least 15 minutes.
The safety and efficacy of ferric carboxymaltose injection for treatment of IDA were evaluated in 2 clinical trials in which the drug was administered at a dose of 15 mg/kg body weight up to a maximal single dose of 750 mg of iron on 2 occasions separated by at least 7 days up to a maximal cumulative dose of 1500 mg of iron.
Patients with various comorbidities and those with a history of drug allergies were included in the trials. The entire Injectafer program consisted of more than 11,000 patients treated with either the drug or a comparator.
Outside of North America, the drug is manufactured and marketed under the name of Ferinject (ferric carboxymaltose). Ferinject is currently registered in 46 countries and is marketed in 37 countries worldwide.
Dosage and Administration
Ferric carboxymaltose injection is supplied as 750 mg of iron/15 mL single-use vial.
Patients weighing at least 50 kg (110 lb) should receive ferric carboxymaltose injection in 2 doses (each 750 mg) separated by at least 7 days, for a total cumulative dose of 1500 mg of iron per course.
Patients weighing less than 50 kg (110 lb) should receive ferric carboxymaltose injection in 2 doses separated by at least 7 days. Each dose should be 15 mg/kg body weight.
If IDA recurs, ferric carboxymaltose injection treatment may be repeated.
Warnings and Precautions
Ferric carboxymaltose injection is contraindicated in patients with hypersensitivity to the product or to any of its inactive components.
During and after administration of ferric carboxymaltose injection, patients should be observed for signs and symptoms of hypersensitivity reactions for at least 30 minutes and until clinically stable after completion of each administration.
After administration of each ferric carboxymaltose injection, patients should be also be closely monitored for signs and symptoms of hypertension.
Caution is recommended when ferric carboxymaltose injection is given to a woman who is breast-feeding.
Nausea, hypertension, flushing, hypophosphatemia, and dizziness are the most common adverse reactions, occurring in more than 2% of patients. Suspected adverse reactions can be reported to the drug manufacturer at 1-800-734-9236 or to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
More information on the approval of the ferric carboxymaltose injection is available on the FDA Web site.
Laurie Barclay, MD, has contributed to this synopsis.
