Gilead’s Captisol-enabled Remdesivir Approved for Use in Renally Impaired Patients
Read full release and find prescribing information
Gilead’s Captisol-enabled Remdesivir Approved for Use in Renally Impaired Patients
Read full release and find prescribing information
Captisol is eliminated by glomerular filtration in the kidneys. Despite more than two decades of patient experience, there are those that still question the safety of Captisol in patients with severe renal impairment. However, recent data has shown that this is not necessarily the case.
Clinical studies were performed in renally compromised patients on BAXDELA (a Captisol-enabled product). Conclusions from these studies stated that “Increased SBECD exposures did not result in any noticeable increase in drug-related TEAEs in this study.” And “… decreasing renal function causes reduced SBECD (Captisol) clearance and increased exposures, but SBECD continues to exhibit a good safety and tolerability profile in IV formulations.”
In another Captisol-enabled drug product, Gilead performed clinical safety studies for Veklury in patients with moderately and severely reduced kidney function. The results of the study were very favorable and In August 2023 the package insert for Veklury was changed to state that “No dosage adjustment of VEKLURY is recommended for patients with any degree of renal impairment, including those on dialysis…”
