Ferric carboxymaltose

(Injectafer®)

Ferric carboxymaltose

Drug updated on 11/1/2024

Dosage FormInjection (intravenous; 50 mg/mL, 100 mg/2 mL, 750 mg/15 mL, 1000 mg/20 mL)
Drug ClassIron 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.

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Summary
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  • This summary is based on the review of 23 systematic review(s)/meta-analysis(es). [1-23]
  • Hemoglobin Increase: FCM (ferric carboxymaltose) was probably superior to IS in increasing hemoglobin levels (RR (relative risk) 1.25, 95% CI (confidence interval) 1.06 to 1.46, NNTB = 9). In pregnant women, FCM showed a significant increase in hemoglobin compared to IS/polymaltose (SMD (standardized mean difference) 0.89 g/dL, 95% CI 0.27 to 1.51).
  • Serum Ferritin Levels in Pregnancy: FCM significantly increased serum ferritin levels compared to IS/polymaltose in pregnant women (SMD 22.53 µg/L, -7.26 to 52.33).
  • RBC Utilization Preoperatively: IV iron monotherapy did not notably reduce RBC utilization, but combining iron with ESAs (Erythropoiesis-stimulating agents) likely reduced the number of RBC units transfused (moderate-certainty evidence).
  • Resolution of IDA in IBD: FCM probably led to higher IDA resolution rates in IBD patients compared to IS (150/244 vs. 118/239, RR 1.25, 95% CI 1.06 to 1.46).
  • Hypophosphatemia prevalence associated with FCM ranged from 0.0% to 92.1%, with clinical consequences including severe fatigue, osteomalacia, and bone deformities observed in patients with acute and chronic hypophosphatemia.
  • FCM was linked to fewer adverse events than IS in the general population, including pregnant women and heart failure patients, with HF patients on FCM showing a lower incidence of hypophosphatemia-related adverse events compared to those on placebo.
  • No serious adverse events were reported for FCM or other IV iron formulations across various studies, including those involving pregnant women and other subgroups.
  • Ferric carboxymaltose (FCM) demonstrated increased effectiveness and a favorable safety profile in specific subgroups, including pregnant women (higher efficacy and fewer adverse events than iron sucrose), heart failure patients (reduced HF-related and cardiovascular hospitalizations without increased mortality), and patients with inflammatory bowel disease (more effective resolution of iron deficiency anemia compared to iron sucrose).

Product Monograph / Prescribing Information

Document TitleYearSource
Injectafer (ferric carboxymaltose) Prescribing Information.2023American Regent, Inc., Shirley, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
A meta-analysis of ferric carboxymaltose versus other intravenous iron preparations for the management of iron deficiency anemia during pregnancy2024Revista Brasileira De Ginecologia E Obstetricia : Revista Da Federacao Brasileira
Effect of IV ferric carboxy maltose for moderate/severe anemia: a systematic review and meta-analysis2024Frontiers In Medicine
Ferric carboxymaltose for iron deficiency in patients with heart failure: a systematic review and meta-analysis2024Future Science Oa
Clinical effectiveness of ferric carboxymaltose (iv) versus iron sucrose (iv) in treatment of iron deficiency anaemia in pregnancy: A systematic review and meta-analysis2024The Indian Journal Of Medical Research
Efficacy of ferric carboxymaltose in heart failure with iron deficiency: an individual patient data meta-analysis2023European Heart Journal
Hypophosphataemia risk associated with ferric carboxymaltose in heart failure: A pooled analysis of clinical trials2023Esc Heart Failure
A systematic literature review and meta-analysis of the incidence of serious or severe hypersensitivity reactions after administration of ferric derisomaltose or ferric carboxymaltose2023International Journal Of Clinical Pharmacy
Systematic review and meta-analysis of intravenous iron-carbohydrate complexes in HFrEF patients with iron deficiency2023Esc Heart Failure
Efficacy and safety of intravenous iron repletion in patients with heart failure: a systematic review and meta-analysis2023Clinical Research In Cardiology : Official Journal Of The German Cardiac Society
Effect of intravenous iron replacement on recurrent heart failure hospitalizations and cardiovascular mortality in patients with heart failure and iron deficiency: A Bayesian meta-analysis2023European Journal Of Heart Failure
Osteomalacia as a Complication of Intravenous Iron Infusion: A Systematic Review of Case Reports2022Journal Of Bone And Mineral Research : The Official Journal Of The American
A Systematic Review, Meta-Analysis, and Indirect Comparison of Blindly Adjudicated Cardiovascular Event Incidence with Ferric Derisomaltose, Ferric Carboxymaltose, and Iron Sucrose2022Advances In Therapy
Iron Formulations for the Treatment of Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: A Cost-Effectiveness Analysis in Switzerland2021Advances In Therapy
Effectiveness of Iron Supplementation With or Without Erythropoiesis-Stimulating Agents on Red Blood Cell Utilization in Patients With Preoperative Anaemia Undergoing Elective Surgery: A Systematic Review and Meta-Analysis2021Transfusion Medicine Reviews
Interventions for treating iron deficiency anaemia in inflammatory bowel disease2021The Cochrane Database Of Systematic Reviews
Hypophosphataemia after treatment of iron deficiency with intravenous ferric carboxymaltose or iron isomaltoside-a systematic review and meta-analysis2021British Journal Of Clinical Pharmacology
Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for iron deficiency anemia in obstetric and gynecologic patients: A systematic review and meta-analysis2021Medicine
Indirect comparison between ferric carboxymaltose and oral iron replacement in heart failure with reduced ejection fraction: a network meta-analysis2021Monaldi Archives For Chest Disease = Archivio Monaldi Per Le Malattie Del Torace
Effect of iron supplementation in patients with heart failure and iron deficiency: A systematic review and meta-analysis2021International Journal Of Cardiology. Heart & Vasculature
Iron preparations for women of reproductive age with iron deficiency anaemia in pregnancy (FRIDA): a systematic review and network meta-analysis2021The Lancet. Haematology
Hypophosphatemia Associated with Intravenous Iron Therapies for Iron Deficiency Anemia: A Systematic Literature Review2020Therapeutics And Clinical Risk Management
Diagnosis and treatment of iron-deficiency anemia in gastrointestinal bleeding: A systematic review2020World Journal Of Gastroenterology
Ferric carboxymaltose for the treatment of iron-deficient heart failure patients: a systematic review and meta-analysis2020Esc Heart Failure

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