difelikefalin

FDA Drug Profile — Korsuva

Drug Details

Generic Name
difelikefalin
Brand Names
Korsuva
Application Number
NDA214916
Sponsor
Vifor (International), Inc.
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
DIFELIKEFALIN ACETATE

Indications and Usage

1 INDICATIONS AND USAGE KORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). KORSUVA is a kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). ( 1 ) Limitation of Use Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population. ( 1 ) Limitations of Use KORSUVA has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.