The Food and Drug Administration (FDA) has approved a labeling update for Vemlidy (tenofovir alafenamide; Gilead Sciences) to include dosage information regarding its use in adults with end-stage renal disease (ESRD; CrCl <15mL/min) who are receiving chronic hemodialysis.
The update states that no dosage adjustment of Vemlidy is needed in patients with mild, moderate, or severe renal impairment, or in patients with ESRD (estimated CrCl <15mL/min) who are receiving chronic hemodialysis. On hemodialysis day, Vemlidy should be administered after hemodialysis is completed. Vemlidy is not recommended in patients with ESRD who are not receiving hemodialysis; the safety of Vemlidy has not been established in this population.
The labeling updated was based on data from an open-label pharmacokinetics and safety study involving 55 HIV-1 infected adults with ESRD receiving chronic hemodialysis; patients in the study were treated with a combination of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150mg/150mg/200mg/10mg. Results showed that tenofovir alafenamide 10mg achieved similar exposures as the 25mg strength alone; the safety profile was consistent with that expected in patients with ESRD on chronic hemodialysis and HIV-1 infection.
Vemlidy is a nucleoside analogue (reverse transcriptase inhibitor) approved to treat chronic hepatitis B virus (HBV) infection in adults with compensated liver disease. It is available as 25mg tablets in 30-count bottles.
For more information call (800) 445-3235 or visit Vemlidy.com.