Difelikefalin

(Korsuva®)

Korsuva®

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 50 mcg/mL)
Drug ClassKappa opioid receptor agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

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Summary
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  • Korsuva (difelikefalin) is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Difelikefalin significantly improved the Worst Itching Intensity Numerical Rating Scale (WI-NRS) with a risk ratio (RR) of 1.28 (95% CI: 1.07 to 1.53) in adult hemodialysis patients with chronic kidney disease-associated pruritus (CKD-aP).
  • Difelikefalin decreased the 5-D Itch Scale score with a standardized mean difference of -0.43 (95% CI: -0.55 to -0.30), indicating a reduction in pruritus severity and improvement in quality of life.
  • The effectiveness of difelikefalin in enhancing quality of life was also observed through positive outcomes on the Skindex score in the same patient population.
  • The meta-analysis reported a significant increase in adverse events associated with difelikefalin use, with a risk ratio (RR) of 1.33 and a 95% confidence interval (CI) of 1.13 to 1.56. The most commonly reported side effects were mild, including nausea, vomiting, dizziness, and diarrhea.
  • The majority of adverse events reported were mild, with no severe safety concerns noted.
  • The reviewed studies focused exclusively on adult hemodialysis patients with chronic kidney disease-associated pruritus (CKD-aP), with no significant differences in effectiveness or safety noted among different population types or subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
Korsuva (difelikefalin) Prescribing Information.2021Vifor (International) Inc., St. Gallen, Switzerland

Systematic Reviews / Meta-Analyses