Difelikefalin

KORSUVA

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Pronunciation: dye-fel-i-KEF-a-lin

Difelikefalin ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Difelikefalin ballicule

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.

Difelikefalin molecular structure (skeletal formula) — Molecular structure: Difelikefalin

FDA-approved for

uremic pruritus (2021)

FDA label

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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.

Instructions

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

Available strengths

inj 50 mcg/mL

Cautions

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

Adverse reactions

Diarrhea
Dizziness
Nausea
Gait disturbances / falls
Hyperkalemia
Headache
Somnolence
Mental status change

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.

Cost

Difelikefalin (KORSUVA)

Strength		#/mo	generic $/unit	CostPlus
50 mcg/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Difelikefalin is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

NO BOXED WARNINGS

Principal riskSomnolence and dizziness

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability1 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryN/A (post-2015 labeling)

Defining liabilityDizziness, somnolence, confusion, and falls during hemodialysis treatment

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