Peripherally restricted kappa-opioid agonist Pregnancy: The limited human data in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. In animal reproduction studies, intravenous injection to pregnant rats and rabbits during organogenesis at doses 711 and 10 times the maximum recommended human dose respectively resulted in no adverse effects.

Difelikefalin

Brand names: Kapruvia

Difelikefalin is an agent used to treat moderate to severe pruritus associated with chronic kidney disease in adults on haemodialysis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 0.5 micrograms/kg (0.5 mcg/kg), based on the patient's target dry body weight

Route: Intravenous bolus injection into the venous line of the dialysis circuit at the end of each haemodialysis treatment. Do not mix or dilute prior to administration

Frequency: At the end of each haemodialysis treatment

Indication in this label: moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing haemodialysis. ADMINISTRATION: the product is removed by the dialyser membrane and must be administered after blood is no longer circulating through the dialyser - give at the end of the haemodialysis session, either during or after rinse back of the dialysis circuit. If the dose is given after rinse back, administer into the venous line followed by at least 10 mL of normal saline flush; if given during rinse back, no additional saline flush is needed. The dose must be administered within 4 hours of syringe preparation. MISSED DOSE: if a regularly scheduled haemodialysis treatment is missed, resume at the end of the next haemodialysis treatment. VOLUME CALCULATION (50 micrograms/mL solution): total injection volume (mL) = patient target dry body weight (kg) x 0.01, rounded to the nearest tenth (0.1 mL); the label's table gives, for example, 36-44 kg = 0.4 mL, 45-54 kg = 0.5 mL, 55-64 kg = 0.6 mL, 65-74 kg = 0.7 mL, 75-84 kg = 0.8 mL, 85-94 kg = 0.9 mL, 95-104 kg = 1 mL, rising to 195-204 kg = 2 mL; use the formula for weights outside these ranges. Supplied as a single-dose vial of 65 micrograms/1.3 mL (50 micrograms/mL); one patient may use less than the full contents of a vial or more than one vial - discard any unused product. PAEDIATRIC: safety and effectiveness in paediatric patients have not been established. SOURCE: no UK SPC (eMC) record was retrieved in this bundle - the dose above is from US prescribing information (KORSUVA, Vifor (International) Inc., label date 2025-08-26, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d0f4d9e-7a5e-4320-96ca-da538aec0c2f) and must be verified against UK labelling.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None (US label section 4 states 'None')

Side effects

Diarrhoea and nausea
Dizziness and somnolence (somnolence more frequent in patients 65 years and older: 7.0% versus 2.8%)
Gait disturbances, including falls
Hyperkalaemia
Headache and mental status change

Clinical monograph

How it works

It is a peripherally restricted, selective kappa opioid receptor agonist that reduces itch through actions on peripheral sensory neurones and immune cells, with limited central penetration.

Prescribing in practice

Dizziness, somnolence and altered mental status can occur, with an additive risk when combined with sedating or centrally acting agents.
It is administered intravenously into the dialysis circuit at the end of haemodialysis sessions.
Caution is advised in patients receiving other CNS depressants because of additive sedation.

Monitoring

Monitor itch severity and response, and watch for dizziness, drowsiness or mental status changes.

Counselling the patient

This medicine is given through your dialysis line at the end of your session.
Tell the team if you feel unusually drowsy or dizzy.
It is intended to relieve itching and may take some time to show full benefit.

Evidence & guidelines

Difelikefalin is licensed for chronic kidney disease-associated pruritus in haemodialysis patients on the basis of randomised controlled trial data.

Reference: NICE TA890; KDIGO; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways