Currently Enrolling Trials
Injectafer (ferric carboxymaltose injection) is used as an iron replacement product. It is an iron carbohydrate complex.
Injectafer is specifically indicated for the treatment of iron deficiency anemia in adults and pediatric patients 1 year of age and older who have intolerance to oral iron or have had unsatisfactory response to oral iron or adults who have non-dialysis dependent chronic kidney disease.
Injectafer is also approved for the treatment of iron deficiency in adult patients with heart failure categorized as New York Heart Association class II/III to improve exercise capacity.
Injectafer is supplied as a solution for intravenous administration. The recommended dosing is as follows:
For patients weighing 50 kg (110 lb) or more: Give Injectafer in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.
For patients weighing less than 50 kg (110 lb): Give Injectafer in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.
For adult patients with heart failure and New York Heart Association class II/III, dosing is based on patient weight (154.3 lbs) and hemoglobin level (ranges from <10 to 14-15 grams per deciliter (g/dl), starting at a single 500 mg dose up to two 1000 mg doses separated by six weeks). A maintenance dose of 500 mg may be administered at 12, 24 and 36 weeks for certain patients based on their serum ferritin levels and transferrin saturation value.
The FDA approved a single 1000 mg dose option of Injectafer in May of 2021.
Mechanism of Action
Injectafer (ferric carboxymaltose injection) is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.
Adverse events associated with the use of Injectafer may include, but are not limited to, the following:
Clinical Trial Results
The FDA approval of Injectafer for treatment of iron deficiency anemia was based on two clinical trials (Trial 1 and Trial 2) in which Injectafer was administered at a dose of 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a maximum cumulative dose of 1500 mg of iron.
This study enrolled 2,561 high risk patients with iron deficiency anemia and chronic kidney disease (CKD). It compared Injectafer to Venofer (iron sucrose injection. Data showed that two 750 mg doses of Injectafer raised hemoglobin more than five 200mg doses of Venofer, with a change in hemoglobin of 1.13 g/dL for Injectafer vs. 0.92 for Venofer. These increases were statistically significant (treatment difference = 0.2). Rates of the adjudicated composite safety endpoint comprised of death, myocardial infarction, stroke, unstable angina, congestive heart failure, arrhythmias, hypertension and hypotension were statistically similar at 13.71% for Injectafer vs. 12.14% for Venofer. Rates of a composite of death, myocardial infarction and stroke were 1.88% for Injectafer vs. 2.72% for Venofer.
This trial enrolled approximately 1,000 subjects with iron deficiency anemia of various etiologies. The trial compared two 750 mg doses Injectafer to either oral or IV iron (standard of care therapy). Injectafer raised hemoglobin more than oral iron or IV standard of care therapy, with a mean change in hemoglobin of 1.57 g/dL vs. 0.80 g/dL when compared to oral iron and 2.90 g/dL vs. 2.16 g/dL when compared with IV standard of care therapy. These increases were statistically significant (p=0.001). Cardiovascular safety was evaluated based on an adjudicated composite safety endpoint comprised of death, myocardial infarction, stroke, unstable angina, congestive heart failure, arrhythmias, hypertension and hypotension. Rates of the composite safety endpoint were 3.95% for Injectafer vs. 4.90% when compared to IV standard of care and at 2.85% for Injectafer vs. 1.58% when compared to oral iron.
The FDA approval of Injectafer in heart failure patients was was supported by data from a randomized controlled study, CONFIRM-HF that evaluated the efficacy and safety of Injectafer in adult patients with chronic heart failure and iron deficiency. Treatment with Injectafer significantly improved exercise capacity compared to placebo in iron deficient patients with heart failure.