Evaluation of Minimal Optimal Dose of Intravenous Ferric Carboxymaltose for Treatment of Iron Deficiency Anemia and Risk of Transient Hyperferritinemia

Abstract

Background

Iron supplementation is administered orally or intravenously to treat iron-deficiency anemia (IDA). Ferric Carboxymaltose (FCM) “Ferinject^®” is an intravenous (IV) iron preparation that has emerged as a safe therapeutic option for treating IDA in the past decade.

Aim

This study aimed to evaluate safety and efficacy of carboxymaltose in a cohort of patients with IDA not responding to oral therapy.

Methods

This 12-month retrospective study included 106 patients with IDA, with-or without bariatric surgery, who received (single or multiple doses) of Carboxymaltose 500mg/10mL. Data points included patients’ demographics, baseline data for Hb, platelet, ferritin, and MCV pre–and at 1, 2, and 3 months following different doses of IV-Carboxymaltose. Changes in Hb, MCV, platelets, and ferritin levels were recorded in response to Carboxymaltose to assess the optimal dose, risk of hyperferritinemia, and hypophosphatemia.

Results

At three months (95 days) follow-up, the median change pre-and post-therapy in hemoglobin was from 9.5 to 11.9g/dL (p < 0.01), MCV 73.6–80.5fL (p < 0.01), and ferritin 5.3–93.8ng/mL. A significant difference was observed between platelet count of patients who underwent bariatric surgery and those who did not. An optimal ferritin response (>30ng/mL) was observed in 87.8% of patients who received first dose, and none of the full three doses showed no response. 37% of patients who received two doses developed hyperferritinemia. Serum phosphate levels were assessed in 28 cases, and hypophosphatemia was observed in 25% of these patients.

Conclusion

Carboxymaltose is a reliable option for IDA. IV-FCM therapy helps achieve significant improvement in hemoglobin concentration and MCV from the first dose carrying a low reversible risk of hyperferritinemia following multiple doses. An interesting finding of this study is the discovery of a population of IDA patients requiring periodic assessment for iron reinfusion to sustain normal levels, mostly post-bariatric surgery. Changes in serum phosphate levels reported to occur consecutively with FCM treatment should be further studied.

Keywords:

• iron deficiency
• anemia
• ferrous carboxymaltose
• hypophosphatemia

Data Sharing Statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Ethics Approval and Consent to Participate

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Dr. Sulaiman Al Habib Medical Group.

Consent to Participate

Informed consent was obtained from all individual participants included in the study.

Consent to Publish

All authors consent for publication. The authors also affirm that human research participants provided informed consent for publication related to their data.

Acknowledgments

Authors would like to acknowledge Dr. Nazia Sadaf for her freelance medical editing services.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. All authors read and approved the final manuscript.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.