Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 65 mcg /1.3 mL [ 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
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Difelikefalin significantly reduced pruritus in patients with chronic kidney disease-associated pruritus (CKD-ap), with a mean decrease in WI-NRS score of -0.99 (95% confidence interval (CI): -1.22, -0.75; p < .00001), a reduction in the 5-D Itch Scale (mean difference (MD): -1.51 [95% CI: -2.26, -0.76]; p > .0001), and improvement in Skindex-10 total score (MD: -7.39 [95% CI: -12.51, -2.28]; p = .005).
- While difelikefalin was effective, other treatments like gabapentin had a higher likelihood (69.74%) of being the most effective for pruritus relief in hemodialysis patients with uremic pruritus (UP).
- Difelikefalin was associated with a significantly higher incidence of adverse events compared to placebo (relative risk (RR): 1.26, 95% CI: 1.03, 1.55; p = .03), although there was no significant difference in serious adverse events (RR: 1.42, 95% CI: 0.78, 2.57; p = .25) or mortality (RR: 0.81, 95% CI: 0.19, 3.34; p = .77).
- Common mild adverse effects of difelikefalin included nausea, vomiting, dizziness, and diarrhea, which were frequently reported in patients with end-stage renal disease and chronic kidney disease-associated pruritus.
- In clinical trials, difelikefalin improved quality of life as assessed by the 5-D Itch Scale and Skindex score, demonstrating its effectiveness in alleviating pruritus symptoms in end-stage renal disease (ESRD) patients.
- Difelikefalin was evaluated in patients with ESRD and CKD-ap, showing significant effectiveness in reducing pruritus and improving quality of life, with a safety profile that includes mild adverse effects such as nausea, vomiting, dizziness, and diarrhea.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Korsuva (difelikefalin) Prescribing Information. | 2024 | Vifor (International) Inc., St. Gallen, Switzerland |