May 6, 2021

The U.S. FDA has approved a new single-dose option for Injectafer® (ferric carboxymaltose injection), manufactured by Daiichi Sankyo. Injectafer is indicated to treat iron deficiency anemia (IDA) in adults who have intolerance to oral iron, have had unsatisfactory response to oral iron, or have non- dialysis-dependent chronic kidney disease. It first received FDA approval in 2013 for a two-dose treatment schedule.

The most common form of anemia, IDA is the result of the body not having enough iron to produce hemoglobin. Hemoglobin is a protein found in red blood cells that helps carry oxygen. IDA can cause symptoms such as fatigue, weakness, shortness of breath, fast or irregular heartbeat, and headaches. There are many causes of IDA, including insufficient iron intake, inability to absorb iron from the diet, and blood loss due to menstruation, childbirth, endometriosis, ulcers, and other sources of bleeding.

The FDA granted approval for the single-dose option based on clinical trials that established its safety and efficacy. Under the recommended dosing, Injectafer can be given as single dose of 15mg/kg of the patient’s body weight to a maximum of 1,000mg in patients who weigh at least 50kg (110 pounds). Alternatively, it can be given as two separate doses of up to 750mg (for a total cumulative dose of 1,500mg) spaced at least seven days apart. The two-dose option is the only option recommended for patients who weigh less than 50kg.

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