IQIRVO: selected primary-label renal guidance and limits
What matters first
Product: Adult oral IQIRVO for labeled primary biliary cholangitis; baseline renal guidance is distinct from treatment-emergent muscle/kidney toxicity.
- Renal action / finding
- Mild/moderate/severe impairment: usual dose.
- Evidence or dialysis limit
- Severe-renal PK study excluded dialysis; no dialysis regimen established.
- Monitoring / application
- Assess muscle symptoms and myopathy/CPK risk; AKI can accompany rhabdomyolysis.
- Product / population
- Adult oral IQIRVO for labeled primary biliary cholangitis; baseline renal guidance is distinct from treatment-emergent muscle/kidney toxicity.
- Renal measure
- Renal categories; severe-renal PK study used indexed MDRD eGFR and excluded dialysis
- Source revision
- Revision date not captured in selected review; retrieval date is not revision date.
- Retrieved
- 2026-11-07 (not the revision date)
Severe-renal PK study excluded dialysis; no dialysis regimen established.
Selected renal section, not a complete prescribing monograph. A label and its mirror are not independent evidence.
Sections 8.6, 12.3 and 5.1
The usual dose also applies in mild, moderate and severe renal impairment. The severe-renal PK study involved patients not on dialysis, so it does not establish a dialysis regimen. Rhabdomyolysis with acute kidney injury has been reported. Evaluate muscle symptoms before treatment and consider clinical/CPK monitoring during therapy; review interacting myotoxic drugs.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d78aa14f-6ec1-4b1d-a4ae-e48658137a25
