JINARC (tolvaptan), vasopressin antagonist
NEPHROLOGY - New medicinal product
Opinions on drugs - Posted on Apr 06 2016
Reason for request
- JINARC has been granted a Marketing Authorisation to slow the progression of the development of cysts and renal failure in autosomal dominant polycystic kidney disease (ADPKD) in adults with stage 1 to 3 chronic kidney disease (CKD) at treatment initiation, with signs of rapid disease progression.
- It reduces the total kidney volume but does not prevent the growth of cysts or cause their decrease. When the treatment is stopped, growth of the renal cysts resumes. Chronic treatment with tolvaptan is thus required even if the safety of an elevated cumulative dose is unknown.
- Its use should be limited only to adults with confirmed (Pei-modified Ravine criteria, family history or genetic testing), progressive ADPKD at risk of unfavourable progression of renal function.
- There are still uncertainties regarding the long-term hepatic safety and the consequences of combination with medicinal products that block the renin-angiotensin system.
Clinical Added Value
Évaluation des médicaments