Safety of RAPid INJECTion of undiluted ferric carboxymaltose to patients with iron deficiency anaemia (RAPINJECT): A phase II single arm study
- Author(s)
- Pasricha, SR; Gilbertson, M; Indran, T; Bennett, A; van Dam, M; Coughlin, E; Dev, A; Chunilal, S; Opat, S;
- Details
- Publication Year 2021-01-18,Volume 51,Issue #8,Page 1304-1311
- Journal Title
- Internal Medicine Journal
- Abstract
- BACKGROUND: Ferric carboxymaltose is increasingly utilised to treat iron deficiency and is usually diluted in saline and administered as an intravenous infusion over 15 minutes. Whilst this is highly convenient compared with older formulations, we hypothesised the drug could be administered safely given as a rapid bolus injection. AIMS: To define the risk of serious adverse events following administration of an undiluted, rapid, high dose ferric carboxymaltose injection. Secondary aims included all other adverse events, as well as longitudinal effects on haemoglobin, iron stores, phosphate, and hepcidin. METHODS: In a single arm, Phase II study in 121 patients with iron deficiency anaemia, we administered up to 1000mg of ferric carboxymaltose as a rapid undiluted bolus injection, and recorded adverse events and collected blood samples over the first hour, and again at two and four weeks post-treatment. RESULTS: No patient experienced a serious adverse event. Flushing during the injection was common, as was a transient headache in the subsequent weeks. A single patient experienced Grade 3 chest tightness necessitating emergency department assessment but not admission or treatment. Treatment produced an average 12.3g/L improvement in haemoglobin within two weeks, but commonly caused reductions in serum phosphate (although none of these were clinically symptomatic). Parenteral iron caused elevations in hepcidin sustained to four weeks post injection. Patients stated they would be prepared to receive the treatment again. CONCLUSION: Rapid injection of undiluted ferric carboxymaltose is well tolerated and could provide an approach to treat patients in the ambulatory setting. This article is protected by copyright. All rights reserved.
- Publisher
- Wiley
- Keywords
- Administration and Dosage; Anaemia; Iron Deficiency
- Research Division(s)
- Population Health And Immunity
- PubMed ID
- 33462917
- Publisher's Version
- https://doi.org/10.1111/imj.15195
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2021-03-09 08:05:31
Last Modified: 2022-02-21 10:45:09