ORLANDO, Fla.—Ferumoxytol, a novel IV iron replacement therapy for CKD patients with iron deficiency anemia, is well tolerated regardless of the number of injections or interval between injections, data show.
The finding is based on a review of pooled data from three pivotal studies in 590 adult CKD patients (429 nondialysis and 161 on hemodialysis) who received two rapid injections of ferumoxytol 510 mg within two to eight days.
The researchers, led by Amit Sharma, MD, of the Boise Kidney & Hypertension Institute in Meridian, Idaho, found no meaningful difference in the overall incidence of acute adverse events (AEs) following one or two injections (7.8% and 4.8%, respectively). They observed no clear association between the incidence of AEs and the timing of the second injection. In fact, the investigators pointed out, the shortest interval between injections—two days—was associated with one of the lowest AE rates (6.5%).
In addition, the study revealed a low incidence of hypotension and AEs potentially associated with hypersensitivity within the first 24 hours of injection. Hypotension occurred in only two patients (0.3%) after the first injection and four patients (0.7%) after the second. AEs potentially associated with hypersensitivity occurred in six patients (1%) after the first injection and three patients (0.5%) after the second.
The researchers presented their findings here at the National Kidney Foundation’s 2010 Spring Clinical Meetings.