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Jynarque
tolvaptan
Black Box Warnings .
Appropriate Use
restricted distribution program (Jynarque REMS) due to serious liver injury risk; prescribers, pharmacies, and pts must enroll at 1-877-726-7220 or www.jynarquerems.com
Serious Liver Injury and Monitoring Parameters
can cause serious and potentially fatal liver injury incl. acute liver failure requiring liver transplantation; monitor ALT, AST, bilirubin at baseline, 2wk and 4wk after tx start, then qmo x18mo, then q3mo; prompt action to lab abnormalities or hepatic injury s/sx can mitigate but not eliminate serious hepatotoxicity risk
Adult Dosing .
Dosage forms: TAB: 15 mg, 30 mg, 45 mg, 60 mg, 90 mg
Restricted Distribution in US
- [1-877-726-7220 or www.jynarquerems.com for more info]
autosomal dominant polycystic kidney dz
- [60-120 mg/day PO divided bid]
- Start: 45 mg PO qam and 15 mg PO qpm, may incr. to 60 mg PO qam and 30 mg PO qpm, then to 90 mg PO qam and 30 mg PO qpm; Info: for slowing kidney fxn decline; give 1st dose in am, 2nd dose 8h later; may incr. dose no more frequently than qwk; avoid fluid restriction during tx
renal dosing
- [see below]
- CrCl >60: no adjustment; CrCl 10-60: not defined, caution advised; CrCl <10: avoid use; anuria: contraindicated
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic dz: contraindicated; Info: may use if uncomplicated polycystic liver dz
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.