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Efficacy and safety of intravenous ferric carboxymaltose in moderate to severe postpartum iron deficiency anemia

Rushika Modi, Akshay Modi, Nishant Bhimani, Punit Patel.




Abstract

Background: PPA affects 50–75% of women. Traditional treatments such as oral iron therapy and blood transfusion have significant disadvantages. Oral iron is not usually absorbed or well-tolerated because of gastrointestinal disturbances and requires long time (months) to reach target of hemoglobin (Hb). Due to limitations of prior parenteral iron preparation, search of novel drug resulted in iron sucrose and latest is Ferric carboxymaltose (FCM). Intravenous FCM has a neutral pH and physiological osmolarity allowing for higher single doses over a shorter time periods. It also does not cause dextran- associated immunogenic reactions.

Aims and Objectives: Aims and objectives of the study is to evaluate the safety and efficacy of IV FCM in treatment of postpartum iron deficiency anemia.

Materials and Methods: It was prospective intervention study conducted at the tertiary care center from January 2019 to June 2019. Total 151 postnatal women aged 18–45 years with moderate and severe anemia were included in the study. FCM was administered as an intravenous infusion of 500–1000 mg dose based on requirement in 100 ml of 0.9% normal saline solution over 15 min. Hb and serum ferritin were recorded at baseline and at the end of 6 weeks. Safety and tolerability were assessed by recording the adverse events during the study period.

Results: Mean age of the study participants was 26.4 ± 4.54 years. Total 112 women (74.1%) had moderate anemia and 39 women (25.8%) had severe anemia. Average baseline Hb was 7.82 ± 0.84 g/dl which was significantly increased up to 12.4 ± 1.33 g/dl at 6 weeks (P < 0.05). Serum ferritin was also significantly improved from 16.22 ± 7.54 baseline to 136.21 ± 66.12 at 6 weeks (Difference 115.12 ± 53.21, P < 0.05). No any serious adverse events were reported. Only minor adverse events such as mild itching at injection site (5, 3.3%) palpitation (2, 1.3%) and nausea (1, 0.6%) were reported.

Conclusion: Intravenous FCM therapy was well-tolerated and effective for management of moderate‑to‑severe anemia among postpartum women. It improved Hb and iron stores in the form of serum ferritin with a very few side effects such as mild itching at injection site, palpitation, and nausea.

Key words: Ferric Carboxymaltose; Ferritin; Hemoglobin; Postpartum






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