Excellent
Excellent
Patient Risk:
Low
Summary
The warning claim is directly supported by the boxed warning and the REMS and monitoring requirements in the provided JYNARQUE prescribing information.
Category Scores
Accurate Statements
WARNING: RISK OF SERIOUS LIVER INJURY (tolvaptan/JYNARQUE can cause serious liver injury).
Boxed Warning (Serious Liver Injury): JYNARQUE can cause serious and potentially fatal liver injury; acute liver failure requiring liver transplantation has been reported.
Requires monitoring.
Boxed Warning and Section 5.1/2.2: Measure ALT, AST and bilirubin before initiation, at 2 and 4 weeks after initiation, then monthly for 18 months and every 3 months thereafter.
Requires restricted distribution under a REMS.
Boxed Warning and Section 5.2: Available only through a restricted distribution program under the Tolvaptan for ADPKD Shared System REMS due to risks of liver injury.
Unsupported Statements
Contradictions
Important Omissions
Safety Assessment
Potential Patient Risk:
Low
The evaluated statement accurately reflects label-supported boxed warning risk, monitoring, and restricted distribution; it does not introduce incorrect or additional safety claims.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Excellent