Safety and efficacy of ferric derisomaltose and its effect on blood transfusions in women with severe anaemia from heavy menstrual bleeding

Authors

  • Caryssa Ling Yan Department of Obstetrics and Gynaecology, Tuen Mun Hospital https://orcid.org/0000-0003-0804-3737
  • Benjamin Ross Young WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong
  • Jade Wing Ngan Shek Department of Obstetrics and Gynaecology, Tuen Mun Hospital
  • Po Lam So Department of Obstetrics and Gynaecology, Tuen Mun Hospital

DOI:

https://doi.org/10.12809/hkjgom.23.2.338

Keywords:

Anemia, iron deficiency, Blood transfusion, Ferric derisomaltose, Iron isomaltoside 1000, Menorrhagia

Abstract

Objective: This study investigates the safety and efficacy of ferric derisomaltose (FDI) and its effect on blood transfusion requirements in women with severe anaemia secondary to heavy menstrual bleeding (HMB).
Methods: Medical records of women aged ≥18 years who were admitted to Tuen Mun Hospital with severe iron deficiency anaemia (a haemoglobin level of <8.0 g/dL and a mean corpuscular volume of <80 fL) secondary to HMB in the periods before (1 July 2014 to 30 June 2018) and after (1 July 2018 to 30 June 2022) the introduction of FDI were retrospectively reviewed.
Results: In total, 1373 and 983 patients were admitted before and after the introduction of FDI, respectively. The mean number of blood units transfused per patient decreased from the pre-FDI period to the post-FDI period (2.02 vs 1.19, p<0.001). The decrease remained significant after adjusting for age, ethnicity, baseline haemoglobin, and leiomyoma. In 384 patients who received FDI, 55 (14.3%) had a hypersensitivity reaction (HSR), 41 of which were mild. There were no cases of cardiac or respiratory arrest or allergic reaction necessitating adrenaline administration. The occurrence of an HSR was not associated with the number of known drug allergies (p=0.076), ethnicity (p=0.563), or age (p=0.06). After FDI administration, the mean haemoglobin level increased from 6.2 g/dL to 10.6 g/dL (p<0.001), whereas the mean ferritin increased from 22.5 μg/L to 149 μg/L (p<0.001) at 3 to 4 weeks.
Conclusion: Intravenous FDI is safe and effective for treating severe iron deficiency anaemia secondary to HMB. FDI significantly reduces the requirement for blood transfusions. 14.3% of patients had an HSR. FDI mitigates the burden on blood transfusion services and supports patient blood management principles.

Author Biographies

Caryssa Ling Yan, Department of Obstetrics and Gynaecology, Tuen Mun Hospital

MBChB, MRCOG, DTM&H, DOWH

Benjamin Ross Young, WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong

MSc

Jade Wing Ngan Shek, Department of Obstetrics and Gynaecology, Tuen Mun Hospital

BMedSci, MBChB, MRCOG

Po Lam So, Department of Obstetrics and Gynaecology, Tuen Mun Hospital

MBBS (HK), MMedSc (Genetic Counselling), MSc (Medical Genetics), FHKCOG, FHKAM (O&G)

References

National Institute for Health and Care Excellence. NICE guideline [NG88]. Heavy menstrual bleeding: assessment and management. Available from: https://www.nice.org.uk/guidance/ng88.

Ding C, Wang J, Cao Y, et al. Heavy menstrual bleeding among women aged 18-50 years living in Beijing, China: prevalence, risk factors, and impact on daily life. BMC Womens Health 2019;19:27.

Kocaoz S, Cirpan R, Degirmencioglu AZ. The prevalence and impacts heavy menstrual bleeding on anemia, fatigue and quality of life in women of reproductive age. Pak J Med Sci 2019;35:365-70.

World Health Organization. Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity. Vitamin and Mineral Nutrition Information System (WHO/NMH/NHD/MNM/11.1). Available from: http://www.who.int/vmnis/indicators/haemoglobin.

Despotis GJ, Zhang L, Lublin DM. Transfusion risks and transfusion-related pro-inflammatory responses. Hematol Oncol Clin North Am 2007;21:147-61. DOI: https://doi.org/10.1016/j.hoc.2006.11.002

Chow YF, Cheng BCP, Cheng HK, et al. Hong Kong Society of Clinical Blood Management recommendations for implementation of patient blood management. Hong Kong Med J 2020;26:331-8.

The Government of the Hong Kong Special Administrative Region. Press Releases. Public urged to donate blood as inventories run low amid COVID-19 epidemic. Available from: https://www.info.gov.hk/gia/general/202203/18/P2022031800505.htm.

Litton E, Xiao J, Ho KM. Safety and efficacy of intravenous iron therapy in reducing requirement for allogeneic blood transfusion: systematic review and meta-analysis of randomised clinical trials. BMJ 2013;347:f4822. DOI: https://doi.org/10.1136/bmj.f4822

Sinclair RCF, Nadaraja S, Kennedy NA, Wakatsuki M, Bhandari S. Real-world experience of intravenous ferric derisomaltose evaluated through safety and efficacy reporting in the UK. Sci Rep 2022;12:18859.

Ionescu A, Sharma A, Kundnani NR, et al. Intravenous iron infusion as an alternative to minimize blood transfusion in peri-operative patients. Sci Rep 2020;10:18403.

Kumar A, Brookes MJ. Iron therapy in inflammatory bowel disease. Nutrients 2020;12:3478.

Gemici C, Yetmen O, Yaprak G, et al. Is there any role of intravenous iron for the treatment of anemia in cancer? BMC Cancer 2016;16:661. DOI: https://doi.org/10.1186/s12885-016-2686-2

McDonagh TA, Metra M, Adamo M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 2021;42:3599-726.

Pavord S, Daru J, Prasannan N, et al. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol 2020;188:819-30.

Mansour D, Hofmann A, Gemzell-Danielsson K. A review of clinical guidelines on the management of iron deficiency and iron-deficiency anemia in women with heavy menstrual bleeding. Adv Ther 2021;38:201-25.

Lau SCH, Hung CMW, Leung WC, Leung TW. Intravenous iron therapy for menorrhagic patients with severe iron-deficiency anaemia: a retrospective cohort study. Hong Kong J Gynaecol Obstet Midwifery 2019;19:103-9.

Reinisch W, Staun M, Tandon RK, et al. A randomized, open-label, non-inferiority study of intravenous iron isomaltoside 1,000 (Monofer) compared with oral iron for treatment of anemia in IBD (PROCEED). Am J Gastroenterol 2013;108:1877-88. DOI: https://doi.org/10.1038/ajg.2013.335

Derman R, Roman E, Modiano MR, Achebe MM, Thomsen LL, Auerbach M. A randomized trial of iron isomaltoside versus iron sucrose in patients with iron deficiency anemia. Am J Hematol 2017;92:286-91. DOI: https://doi.org/10.1002/ajh.24633

Rampton D, Folkersen J, Fishbane S, et al. Hypersensitivity reactions to intravenous iron: guidance for risk minimization and management. Haematologica 2014;99:1671-6. DOI: https://doi.org/10.3324/haematol.2014.111492

Lim W, Afif W, Knowles S, et al. Canadian expert consensus: management of hypersensitivity reactions to intravenous iron in adults. Vox Sang 2019;114:363-73.

Beverina I, Razionale G, Ranzini M, Aloni A, Finazzi S, Brando B. Early intravenous iron administration in the Emergency Department reduces red blood cell unit transfusion, hospitalisation, re-transfusion, length of stay and costs. Blood Transfus 2020;18:106-16.

Farmer SL, Trentino K, Hofmann A, et al. A programmatic approach to patient blood management: reducing transfusions and improving patient outcomes. Open Anesth J 2015;9:9-16. DOI: https://doi.org/10.2174/1874321801509010006

World Health Organization. Sixty-Third World Health Assembly. Resolutions and Decisions Anneses. WHA63.12: availability, safety and quality of blood products. Available from: https://apps.who.int/gb/ebwha/pdf_files/WHA63-REC1/WHA63_REC1-en.pdf.

Kalanj K, Marshall R, Karol K, Tiljak MK, Orešković S. The impact of COVID-19 on hospital admissions in Croatia. Front Public Health 2021;9:720948.

Aksan A, Işık H, Radeke HH, Dignass A, Stein J. Systematic review with network meta-analysis: comparative efficacy and tolerability of different intravenous iron formulations for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2017;45:1303-18. DOI: https://doi.org/10.1111/apt.14043

Kalra PA, Bhandari S, Spyridon M, et al. NIMO-CKD-UK: a real-world, observational study of iron isomaltoside in patients with iron deficiency anaemia and chronic kidney disease. BMC Nephrol 2020;21:539.

Lee LLT, Shu W. Efficacy and safety of intravenous iron isomaltoside in postpartum anaemia. Hong Kong J Gynaecol Obstet Midwifery 2022;22:16-20.

Arastu AH, Elstrott BK, Martens KL, et al. Analysis of adverse events and intravenous iron infusion formulations in adults with and without prior infusion reactions. JAMA Netw Open 2022;5:e224488. DOI: https://doi.org/10.1001/jamanetworkopen.2022.4488

Downloads

Published

2023-06-06

How to Cite

1.
Yan CL, Young BR, Shek JWN, So PL. Safety and efficacy of ferric derisomaltose and its effect on blood transfusions in women with severe anaemia from heavy menstrual bleeding. Hong Kong J Gynaecol Obstet Midwifery [Internet]. 2023 Jun. 6 [cited 2024 Nov. 23];23(2). Available from: https://hkjgom.org/home/article/view/338

Issue

Section

Original Article

Most read articles by the same author(s)