Difelikefalin

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). Limitation of Use Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population. Limitations of Use KORSUVA has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

KORSUVA is a kappa opioid receptor (KOR) agonist. The relevance of KOR activation to therapeutic effectiveness is not known.

Recommended dosage is 0.5 mcg/kg. Administer by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment. Do not mix or dilute KORSUVA prior to administration. Administer within 4 hours of syringe preparation. See full prescribing information for additional recommendations on preparation and administration of KORSUVA.

None None

Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances: Dizziness, somnolence, mental status changes, and gait disturbances, including falls, have occurred. Centrally-acting depressant medications, sedating antihistamines, and opioid analgesics should be used with caution during treatment with KORSUVA. Risk of Driving and Operating Machinery: May impair mental or physical abilities. Advise patients not to drive or operate dangerous machinery until the effect of KORSUVA on a patient's ability to drive or operate machinery is known.

The following clinically significant adverse reactions are described elsewhere in the labeling: Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances The most common adverse reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea, dizziness, nausea, gait disturbances, including falls, hyperkalemia, headache, somnolence, and mental status change.

Store vials at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze. KORSUVA injection must be administered within 4 hours of syringe preparation, prepared syringes can be stored at ambient temperature 20°C to 25°C (68°F to 77°F) until dosing.