Drug updated on 9/4/2024
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.
Latest News
Summary
- Injectafer (ferric carboxymaltose) is 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, the treatment of IDA in adult patients who have non-dialysis dependent chronic kidney disease, and the treatment of IDA in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- FCM/FDI significantly reduced the risk of recurrent heart failure hospitalizations and cardiovascular death (RR = 0.81, 95% CI 0.69-0.95, p = 0.01, NNT = 7). Sensitivity analysis confirmed these positive effects (RR = 0.77, 95% CI 0.66-0.90, p = 0.0008, NNT = 6).
- FCM specifically reduced the risk of composite endpoint 1 (total/recurrent cardiovascular hospitalizations and cardiovascular death) (Rate Ratio = 0.86; 95% CI 0.75-0.98; p = 0.029), with a trend towards reduction for endpoint 2 (total heart failure hospitalizations and cardiovascular death) (Rate Ratio = 0.87; 95% CI 0.75-1.01; p = 0.076).
- In obstetric and gynecologic patients, FCM was more effective than iron sucrose (IS) in increasing hemoglobin and ferritin levels post-treatment.
- Hypersensitivity Reactions (HSRs): Serious or severe HSRs were reported in 1.08% of patients treated with FCM, compared to 0.14% of patients treated with FDI, indicating a significantly lower incidence with FDI.
- Hypophosphatemia: FCM was associated with a higher incidence of hypophosphatemia compared to IIM (47% vs. 4%), with some cases persisting for up to 3 months. The incidence was lower in heart failure patients treated with FCM compared to other therapeutic areas.
- Population Types and Subgroup Considerations: FCM and FDI were effective in reducing HF hospitalizations and CVD in HF patients, with FCM showing a lower incidence of hypophosphatemia in this group. FCM was more effective and safer than IS in obstetric and gynecologic patients with IDA. In perioperative patients, FCM improved hematologic parameters and potentially reduced transfusion rates and hospital stays. In CKD patients, particularly those on hemodialysis, FCM was associated with a lower incidence of hypophosphatemia.
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 |
---|---|---|
Herzinsuffizienz: Leitlinien-Update der ESC 2023. | 2024 | Herz |
Practical guidance for diagnosing and treating iron deficiency in patients with heart failure: why, who and how? | 2022 | Journal of Clinical Medicine |