Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France
Kapruvia 50 micrograms/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless solution, free from particles (pH 4.5). |
Each vial of 1 mL contains 50 micrograms difelikefalin (as acetate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Difelikefalin |
Difelikefalin is a selective kappa opioid receptor agonist with low central nervous system penetration. The pathophysiology of chronic kidney disease-associated pruritus is thought to be multifactorial, including systemic inflammation and an imbalance in the endogenous opioid system (e.g., overexpression of mu opioid receptors and concomitant downregulation of kappa opioid receptors). The activation of kappa opioid receptors on peripheral sensory neurons and immune cells by difelikefalin are considered mechanistically responsible for the antipruritic and anti-inflammatory effects. |
| List of Excipients |
|---|
|
Acetic acid (for pH adjustment) |
Kapruvia is supplied in a single use 2 mL glass vial (type I), with a bromobutyl rubber stopper, an aluminium seal and a blue flip-off plastic cap.
Pack sizes of 3 and 12 vials containing 1 mL of solution for injection.
Not all pack sizes may be marketed.
Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France
EU/1/22/1643/001
EU/1/22/1643/002
| Drug | Countries | |
|---|---|---|
| KAPRUVIA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania |
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