Following the US FDA approval of difelikefalin, physicians managing chronic kidney disease (CKD) patients undergoing hemodialysis now have a treatment option for pruritus, which is a very common complication in these patients. Difelikefalin is a first-in-class kappa opioid receptor (KOR) agonist that targets the peripheral nervous system.

The approval of difelikefalin is based on the results of the KALM-1 trial, which was conducted in the US and the KALM-2, which was a global trial. In these trials, treatment with difelikefalin significantly reduced the intensity of itching and also improved itch related quality-of-life in hemodialysis patients with moderate-to-severe CKD-associated pruritus (CKD-aP)

• Indication: Moderate-to-severe pruritus in CKD patients on hemodialysis
• Dose and administration: Injection (0.5 μg/kg three times per week)
• Adverse events: Diarrhea, dizziness, nausea, gait disturbances such as falls, hyperkalemia, headache, somnolence, mental status changes
• Warnings and precautions: Patients undergoing treatment with difelikefalin should be advised not to operate machinery or drive a car while on treatment. Use in combination with opioids, centrally acting depressants, and sedating antihistamines could increase the likelihood of certain AEs.
• Contraindications: Patients on peritoneal dialysis or with severe liver impairment

(Source: Medpage Today, August 24, 2021)