Difelikefalin

KORSUVA

What it isPeripherally restricted kappa agonist; pruritus in hemodialysis.

Why this oneIt relieves uremic itch without CNS kappa effects, so there is no dysphoria.

What limits itSomnolence and dizziness. IV at each dialysis session; cost.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Moderate-to-severe pruritus of CKD in hemodialysis patients	Adults on hemodialysis	0.5 mcg/kg IV bolus at end of each HD treatment	0.5 mcg/kg per HD session

Renal Undefined

Hepatic Not recommended in severe hepatic impairment.

Injection volume is based on target dry body weight.

Administer by IV bolus into the venous line of the dialysis circuit at the end of each HD treatment
Do not mix or dilute; administer within 4 hours of syringe preparation
Single-dose vial — discard any unused product
If a scheduled HD treatment is missed, resume at the end of the next HD treatment

Dizziness, somnolence, mental status changes, and gait disturbances (including falls); higher somnolence in patients ≥65 years
Use CNS depressants, sedating antihistamines, and opioid analgesics with caution
May impair ability to drive or operate machinery

Pregnancy Limited human data insufficient to assess risk; animal studies showed no adverse developmental effects.

Lactation No human data; difelikefalin was transferred into rat milk.

NO BOXED WARNINGS

Principal riskSomnolence and dizziness

Direct muscarinic antagonism0 / 4