Drug updated on 4/24/2024
| Dosage Form | Injection (intravenous; 50 mg/mL, 100 mg/2 mL, 750 mg/15 mL, 1000 mg/20 mL) |
| Drug Class | Iron replacement products |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron
- Indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have non-dialysis dependent chronic kidney disease.
- Indicated for the treatment of iron deficiency anemia (IDA) in iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
Summary
- Ferric carboxymaltose (Injectafer) is approved for the treatment of iron deficiency anemia in various groups. These include adults and pediatric patients over 1 year old who have not responded well or cannot tolerate oral iron, adult patients with non-dialysis-dependent chronic kidney disease, and those with heart failure.
- Two systematic reviews/meta-analyses focused on the comparison of ferric carboxymaltose's efficacy and safety to other treatments, such as iron sucrose, among obstetric/gynecologic patients, and in the treatment of perioperative 3. In one study involving 910 obstetric/gynecologic patients across nine randomized controlled trials, ferric carboxymaltose led to significantly higher post-treatment serum hemoglobin levels compared with iron sucrose, with a mean difference of 0.67 g/dL favoring Injectafer.
- Additionally, ferric carboxymaltose was associated with a lower incidence of adverse events compared to iron sucrose in these patient cohorts; no serious adverse events were reported, indicating a favorable safety profile for Injectafer within this group.
- Another review on the treatment of perioperative anemia showed that preoperative administration of ferric carboxymaltose improved hematological parameters more effectively than comparators like placebo or standard care. It also potentially reduced transfusion rates and lengthened hospital stays among patients undergoing elective surgery and suffering from perioperative anemia.
- Subgroup analyses suggest that findings are consistent across different types of surgeries (such as colorectal, gastric, and orthopedic), enhancing understanding of its applicability in diverse clinical scenarios. This underscores the need for further research, especially concerning long-term effects related specifically to its use in perioperative care settings.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Injectafer (ferric carboxymaltose) Prescribing Information. | 2023 | American Regent, Inc., Shirley, NY |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| [Heart failure: update of the ESC 2023 guidelines] | 2024 | Herz |
| Practical guidance for diagnosing and treating iron deficiency in patients with heart failure: why, who and how? | 2022 | Journal of Clinical Medicine |