The FDA has approved updated labeling for Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to include updated information regarding treatment of patients with hepatitis C virus (HCV) who have severe renal impairment including those with end stage renal disease who are on dialysis.
The FDA has approved a new indication for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease, doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure (HF) in adults with type 2 diabetes (T2D) and diabetic nephropathy with albuminuria >300mg/day.
Drugs in the Pipeline
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease (ESRD) and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).
A recently published report describes the case of a 62-year-old patient who experienced rare but serious central nervous system (CNS) side effects following the initiation of gabapentin therapy.
The Food and Drug Administration (FDA) has approved Zulresso (brexanolone; Sage Therapeutics) injection for the treatment of postpartum depression in adult women, the first drug to be approved for this indication. Zulresso, an analogue of the endogenous human hormone allopregnanolone, is intended for continuous intravenous (IV) infusion over 2.5 days following a titration schedule. It…
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.
Temixys combines lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), which are 2 nucleoside reverse transcriptase inhibitors.
Drugs in the Pipeline
Intradialytic hypotension is a common complication of hemodialysis and can lead to increased morbidity and mortality among patients with end-stage renal disease.
AHA 2017 Scientific Sessions
End-stage renal disease patients on dialysis with atrial fibrillation are at high risk for thrombotic complications.
Uric acid-lowering therapy might improve kidney outcomes, including kidney failure events, proteinuria, and the rate of change in eGFR, and seem to reduce the risk of cardiovascular events in adults with CKD.