KAPRUVIA 50mcg / ml solution for injection medication leaflet

V03AX04 difelikefalin • Various | All other therapeutic products | Other therapeutic products

Difelikefalin is a medicine for moderate to severe itching associated with chronic kidney disease in adults receiving haemodialysis. Kidney-related itching can disturb sleep, mood and daily life. The medicine acts on kappa opioid receptors, mainly outside the brain, to help reduce itch signals.

It is given by injection, usually in the dialysis centre at the end of a haemodialysis session. The dose depends on body weight and dialysis schedule. Patients do not normally inject it at home. Tell the dialysis team if you miss a session, change dialysis days or receive an extra treatment, because timing may need adjustment.

Side effects may include sleepiness, dizziness, headache, tingling, nausea, diarrhoea or mental status changes such as confusion. Report marked drowsiness, disorientation, unsteadiness, falls or unusual symptoms after the injection. Until you know how it affects you, be cautious with driving, machinery or tasks requiring alertness.

Difelikefalin relieves itching but does not cure kidney disease. Your clinician may also check other causes such as dry skin, high phosphate, allergies or other medicines. Continue dialysis and kidney-related treatments as advised. Tell your doctor about all medicines you take, especially sedatives or drugs causing dizziness, and ask for advice if pregnant or breastfeeding.

General data about KAPRUVIA 50mcg / ml

Substance: difelikefalin

Date of last drug list: 01-08-2025

Commercial code: W71262001

Concentration: 50mcg / ml

Pharmaceutical form: solution for injection

Quantity: 3

Product type: original

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: VIFOR FRANCE - FRANTA

Holder: VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE - FRANTA

Number: 1643/2022/01

Shelf life: 2 years

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