General Information

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 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 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.

Clinical Results

FDA Approval

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.
Trial One
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.
Trial Two
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.