Safety and tolerability of intravenous ferric carboxymaltose in patients with iron deficiency anemia
dc.contributor.author | Bailie, George R. | en_US |
dc.contributor.author | Mason, Nancy A. | en_US |
dc.contributor.author | Valaoras, Thomas G. | en_US |
dc.date.accessioned | 2011-01-13T19:42:48Z | |
dc.date.available | 2011-01-13T19:42:48Z | |
dc.date.issued | 2010-01 | en_US |
dc.identifier.citation | Bailie, George R.; Mason, Nancy A.; Valaoras, Thomas G.; (2010). "Safety and tolerability of intravenous ferric carboxymaltose in patients with iron deficiency anemia." Hemodialysis International 14(1): 47-54. <http://hdl.handle.net/2027.42/78671> | en_US |
dc.identifier.issn | 1492-7535 | en_US |
dc.identifier.issn | 1542-4758 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/78671 | |
dc.description.abstract | There is limited safety information about ferric carboxymaltose (FCM), a new intravenous iron preparation. This randomized, crossover study compared the safety and tolerability of double-blinded intravenous doses of FCM or placebo in patients with iron deficiency anemia. Subjects (559) with iron deficiency anemia received a dose of either FCM (15 mg/kg, maximum 1000 mg) over 15 minutes or placebo on day 0. On day 7, subjects received the other agent. Safety evaluations were performed on days 7 and 14. The primary endpoint was the incidence of treatment-emergent adverse events during each 7-day study period. During the first 24 hours and during the 7-day treatment period, at least one treatment-emergent adverse event was experienced by 15.0% and 29.3% of subjects after FCM and 11.4% and 19.7% after placebo, respectively. Most were classified as Grade 1 or 2. Six subjects had Grade 3 treatment-emergent adverse events after FCM and 9 subjects after placebo. One subject had a Grade 4, and 1 subject had a Grade 5 treatment-emergent adverse event, but neither was considered study drug-related. During the first 24 hours of the treatment period, drug-related adverse events were reported in 9.3% of subjects receiving FCM and 4.8% receiving placebo. Of drug-related Grade 3 events, 4 subjects received FCM and 5 subjects received placebo. Administration of FCM (15 mg/kg, maximum of 1000 mg) over 15 minutes was well tolerated and associated with minimal risk of adverse reactions in patients with iron deficiency anemia. | en_US |
dc.format.extent | 121441 bytes | |
dc.format.extent | 3106 bytes | |
dc.format.mimetype | application/pdf | |
dc.format.mimetype | text/plain | |
dc.publisher | Blackwell Publishing Inc | en_US |
dc.subject.other | Ferric Carboxymaltose | en_US |
dc.subject.other | Intravenous Iron | en_US |
dc.subject.other | Iron Deficiency Anemia | en_US |
dc.subject.other | Safety | en_US |
dc.title | Safety and tolerability of intravenous ferric carboxymaltose in patients with iron deficiency anemia | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Oncology and Hematology | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA | en_US |
dc.contributor.affiliationother | Albany College of Pharmacy and Health Sciences, Albany, New York, USA | en_US |
dc.contributor.affiliationother | Renal Pharmacy Consultants, LLC, Ann Arbor, Michigan, USA | en_US |
dc.contributor.affiliationother | Valaoras and Lewis Obstetrics and Gynecology, Winston-Salem, North Carolina, USA | en_US |
dc.identifier.pmid | 19888949 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/78671/1/j.1542-4758.2009.00409.x.pdf | |
dc.identifier.doi | 10.1111/j.1542-4758.2009.00409.x | en_US |
dc.identifier.source | Hemodialysis International | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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