Ferric Carboxymaltose Injection in Postpartum Iron Deficiency Anemia: Results from the prescription-event monitoring study
Journal Title: Indian Journal of Obstetrics and Gynecology Research - Year 2017, Vol 4, Issue 1
Abstract
Introduction: Ferric Carboxymaltose (FCM), a dextran free iron formulation can be administered in large doses without the risk of severe anaphylactic reactions in postpartum anemia (PPA). Evidence suggest that FCM is highly effective in correcting anemia and restoring iron stores faster. Aims & Objective: To gather real-world clinical practice events on safety and efficacy of FCM injection in Indian patients with PPA. Materials and Methods: This was a prospective, observational, non-comparative, non-interventional, prescription event monitoring study. Data were collected from 535 postpartum iron deficiency anemia patients treated with FCM injection. Safety was assessed from adverse events reported within 1 week post FCM administration. Treatment efficacy was assessed by change in Hb from baseline, at 1 week after treatment. Results: There were no serious adverse events (AE) reported. Only 4 patients (<1%) reported AE (mild nausea, n=1; shivering, n=1; palpitation, n=1; pruritus and breathlessness, n=1). Mean change in Hb evaluated in 498 patients showed significant increase from baseline of 8.5 ± 1.2 gm/dl to 10.5 ± 1.0 gm/dl (difference = 2 ± 1.03 gm/dl; p < 0.001) at 1 week post-treatment. Increase in Hb was maximum (2.95 ± 1.08 gm/dl) in severely anemic patients with baseline Hb ≤7 gm/dl (n = 87). Safety and efficacy of FCM was rated by physicians as ‘very good and good’ in 99% patients. Conclusion: Intravenous FCM was safe with AE profile similar to earlier reports. Clinical utility of FCM in the treatment of PPA was demonstrated with significant improvement in Hb in 1 week.
Authors and Affiliations
Manish Pandya, Pankaj Patil, Swati Naik, Shahu Ingole, Rishi Jain
Keywords
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- EP ID EP313088
- DOI 10.18231/2394-2754.2017.0021
- Views 88
- Downloads 0
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