A retrospective study evaluating intravenous (IV) iron formulations suggests that a single dose of ferumoxytol may be safe and effective for patients with iron deficiency, these findings were published in the American Journal of Hematology.
The researchers explained that ferumoxytol is approved as a 2-dose therapy but that there are few available comparisons of outcomes with single-dose ferumoxytol vs other single-dose IV iron treatments.
The study was a multicenter, cohort analysis that featured a comparison of outcomes with single-dose ferumoxytol (467 patients) with single-dose low molecular-weight iron dextran (LMWID; 439 patients). Dosages were 1020 mg for ferumoxytol and 1000 mg for LMWID. The primary efficacy endpoint of the analysis included median changes from baseline in hemoglobin, hematocrit, and ferritin levels 8 to 12 weeks after infusion. The primary efficacy analysis included a total of 351 eligible patients (197 with LMWID and 154 with ferumoxytol). Other analyses included the entire population, and these consisted of evaluations of adverse events (AEs) and the need for further iron infusions.
The median patient age was 53.6 years and the majority of patients (81.2%) were women. For the primary efficacy endpoint, median follow-up occurred at 9.8 weeks with ferumoxytol and at 9.7 weeks with LMWID.
Compared with baseline, the mean change in hemoglobin was 0.8 g/dL with single-dose ferumoxytol, and it was 0.5 g/dL with LMWID, which was not a significant difference (P =.24). The mean change in hematocrit also did not significantly differ between ferumoxytol and LMWID (1.25% and 1.1%, respectively; P =.89), nor did the mean change in ferritin (71 ng/dL vs 87 ng/dL, respectively; P =.47).
AEs occurred in 2.8% of patients with single-dose ferumoxytol and in 2.3% with LMWID. Grade 3 AEs were seen in 0.4% of patients receiving ferumoxytol and in 0.7% receiving LMWID. No grade 4 AEs were reported.
Over the course of a 34-month observation period, further IV infusions were given more often to patients with LMWID (28.5%) than to those receiving ferumoxytol (16.1%; P <.00001). Similar results were obtained in a comparison of patients from the efficacy population.
“This study affirms the safety and effectiveness of single-dose IV LMWID and single-dose IV ferumoxytol. In this trial when administered as a single-dose infusion, ferumoxytol offered decreased infusion requirements and appeared to be a safe and convenient option for IV iron supplementation,” the researchers concluded.
Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
Cohen J, Khudanyan A, Lu J, et al. A multicenter study evaluating the effectiveness and safety of single-dose low molecular weight iron dextran vs single-dose ferumoxytol for the treatment of iron deficiency. Am J Hematol. Published online September 11, 2020. doi:10.1002/ajh.25995