Comparative Review of the Safety and Efficacy of Ferric Carboxymaltose Versus Standard Medical Care for the Treatment of Iron Deficiency Anemia in Bariatric and Gastric Surgery Patients

ABSTRACT Introduction Several intravenous iron preparations are available for the treatment of iron deficiency anemia (IDA). Some of these require multiple small infusions to prevent labile iron reactions, while iron dextran (DEX) is associated with a risk of potentially serious anaphylactic reactions. Ferric carboxymaltose (FCM), a non-DEX intravenous iron, is an effective and a safe option, which can be administered in high single doses without serious adverse effects. Objective The objective of the study was to evaluate the efficacy and safety of FCM in the treatment of IDA in gynecological patients. Materials and methods It was an open, single-arm study including 442 women of age more than 18 years with definitive diagnosis of IDA and hemoglobin (Hb) between 4 and 11 gm% from December 2013 to November 2016. Out of these, 25 women were lost to follow-up and were excluded from the study. Intravenous FCM (500—1500 mg) was administered and the improvement in Hb levels and iron stores was assessed after 3 weeks of total dose infusion. Results Out of the 442 women, 417 women were included in the analysis. Most of the women were in the age group of 30 to 39 years. Most of the women had mild anemia as per the World Health Organization (WHO) guidelines. Mean Hb levels significantly increased over a period of 3 weeks after FCM administration. Other parameters like total iron-binding capacity (TIBC), ferritin, and iron also had a significant improvement after FCM administration. No serious life-threatening adverse events were observed after FCM administration. Conclusion Intravenous FCM is an effective and a safe treatment option for IDA and has an advantage of single administration of high doses without serious adverse effects. How to cite this article Mishra V, Roy P, Gandhi K, Hokabaj S, Aggarwal R. Study of Intravenous Ferric Carboxymaltose in Iron Deficiency Anemia in Women attending Gynecological Clinic: Safety and Efficacy. J South Asian Feder Menopause Soc 2017;5(2):71-74.

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Safety and efficacy of ferric carboxymaltose in children and adolescents with iron deficiency anemia

The Journal of Pediatrics ◽

10.1016/j.jpeds.2017.01.041 ◽

2017 ◽

Vol 184 ◽

pp. 241 ◽

Cited By ~ 10

Author(s):

Elpis Mantadakis ◽

Jelena Roganovic

Keyword(s):

Iron Deficiency ◽

Children And Adolescents ◽

Iron Deficiency Anemia ◽

Deficiency Anemia ◽

Ferric Carboxymaltose ◽

Safety And Efficacy

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Study of safety and efficacy of injection ferric carboxymaltose in iron deficiency anemia in pregnancy

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20212165 ◽

2021 ◽

Vol 10 (6) ◽

pp. 2298

Author(s):

Amrita Jain ◽

Sonia S. Asrani

Keyword(s):

Heart Rate ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Fetal Heart Rate ◽

Fetal Heart ◽

Deficiency Anemia ◽

Ferric Carboxymaltose ◽

Heart Rate Monitoring ◽

Fetal Heart Rate Monitoring ◽

Safety And Efficacy

Background: Iron deficiency is a common nutritional deficiency amongst women of childbearing age. Peri-partum iron deficiency anemia (IDA) is associated with significant maternal, fetal and infant morbidity. Ferric carboxymaltose (FCM) may be better tolerated than the conventional blood transfusions and oral iron supplements. The study was designed to assess the safety and efficacy of IDA correction with intravenous (I.V.) FCM in pregnant women with mild, moderate and severe anemia in their second and third trimesters and their post-partum period. Methods: Prospective observational study; Treatment effectiveness was assessed by repeat hemoglobin (Hb) measurements and patient report of well-being in the postpartum period. Safety was assessed by analysis of adverse drug reactions and fetal heart rate monitoring during the infusion.Results: Intravenous FCM infusion significantly increased Hb values above baseline levels in all women. Fetal heart rate monitoring did not indicate a drug related negative impact on the fetus. No serious adverse effects were found Conclusions: Our prospective data is consistent with existing observational reports of the safe and effective use of ferric carboxymaltose in the treatment of iron deficiency anemia in peri-partum period.

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Safety and efficacy of intravenous ferric carboxymaltose in Japanese patients with iron-deficiency anemia caused by digestive diseases: an open-label, single-arm study

International Journal of Hematology ◽

10.1007/s12185-018-2529-9 ◽

2018 ◽

Vol 109 (1) ◽

pp. 50-58 ◽

Cited By ~ 5

Author(s):

Katsuya Ikuta ◽

Hiroaki Ito ◽

Keiji Takahashi ◽

Shinya Masaki ◽

Masaru Terauchi ◽

...

Keyword(s):

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Japanese Patients ◽

Deficiency Anemia ◽

Ferric Carboxymaltose ◽

Open Label ◽

Safety And Efficacy ◽

Digestive Diseases

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EFFICACY AND SAFETY OF FERRIC CARBOXYMALTOSE IN THE MANAGEMENT OF IRON-DEFICIENCY ANEMIA IN PATIENTS WITH GASTROINTESTINAL AND LIVER DISEASE.

10.26226/morressier.57c53841d462b80296c9c7fe ◽

2016 ◽

Author(s):

Marco Mendolaro

Keyword(s):

Liver Disease ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Deficiency Anemia ◽

Ferric Carboxymaltose ◽

Efficacy And Safety

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Long-Term Effectiveness of Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose for the Treatment of Iron-Deficiency Anemia in Patients With Inflammatory Bowel Disease: A Randomized Controlled Noninferiority Trial

Inflammatory Bowel Diseases ◽

10.1093/ibd/izab073 ◽

2021 ◽

Author(s):

Stefanie Howaldt ◽

Eugeni Domènech ◽

Nicholas Martinez ◽

Carsten Schmidt ◽

Bernd Bokemeyer

Keyword(s):

Inflammatory Bowel Disease ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Primary Endpoint ◽

Bowel Disease ◽

Deficiency Anemia ◽

Ferric Carboxymaltose ◽

Inflammatory Bowel ◽

Intent To Treat

Abstract Background Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability. Methods In this open-label, phase 3b trial (EudraCT 2015-002496-26 and NCT02680756), adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL [women/men]; ferritin, <30 ng/mL/<100 ng/mL with transferrin saturation <20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center’s standard practice. The primary endpoint was a hemoglobin responder rate (≥2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per-protocol populations. Results For the intent-to-treat (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol vs 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the noninferiority margin, the primary endpoint was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 vs 3.0 g/dL, 2.9 vs 2.8 g/dL, and 2.7 vs 2.8 g/dL with ferric maltol vs ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively. Conclusions Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.

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