Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 50 mcg/mL) |
Drug Class | Kappa 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).
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Korsuva (difelikefalin) Prescribing Information. | 2021 | Vifor (International) Inc., St. Gallen, Switzerland |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of difelikefalin in the treatment of hemodialysis patients with pruritus: a meta-analysis and systematic review. | 2024 | Clinical Nephrology |
Difelikefalin in the treatment of chronic kidney disease-associated pruritus: a systematic review. | 2022 | Pharmaceuticals |