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Clinical context remains essential
Independent clinical review is pending. Confirm indication, exact formulation/route, population, renal measure and units, kidney-function stability, dialysis prescription, interacting drugs, monitoring and source revision. An RX mirror and its original label are not independent corroboration. Missing disagreement notes do not certify agreement.
An RX mirror and its underlying label are not independent clinical confirmations.
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IQIRVO: selected primary-label renal guidance and limits
Product / population
Adult oral IQIRVO for labeled primary biliary cholangitis; baseline renal guidance is distinct from treatment-emergent muscle/kidney toxicity.
Renal method
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
Local review status
Selected sections checked against the identified source; not a complete monograph or independent clinician approval.
Documented differences and cautions on this drug
All record notes are retained here, including notes about sources not selected in this review.
IQIRVO: source applicability and renal evidence limits
Baseline no-adjustment guidance does not clear on-treatment rhabdomyolysis/AKI. The non-dialysis severe-renal study must not be relabeled as dialysis validation.
What to reconcile: Assess muscle symptoms and myopathy/CPK risk; AKI can accompany rhabdomyolysis.
DailyMed / product prescribing information · Adult oral IQIRVO for labeled primary biliary cholangitis; baseline renal guidance is distinct from treatment-emergent muscle/kidney toxicity.
Renal method: Renal categories; severe-renal PK study used indexed MDRD eGFR and excluded dialysis Source date: Revision date not captured in selected review; retrieval date is not revision date. Retrieved: 2026-11-07
Qualified no-adjustment statement. Apply only to the population, product and renal range described in this source.
Before using this finding
Severe-renal PK study excluded dialysis; no dialysis regimen established.
Dialysis evidence: No dialysis regimen established in selected content
Selected sections checked against the identified source; not a complete monograph or independent clinician approval.
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.
RDM72-elafibranor-iqirvo-label-1 · Source locator: Sections 8.6, 12.3 and 5.1
Source-specific limits
Selected renal section, not a complete prescribing monograph. A label and its mirror are not independent evidence.
This reference does not select a regimen. Complete the indication, measured/estimated renal function and trend, dialysis setting, source rationale, monitoring and reassessment plan in your institution's approved documentation system. Confirm the complete current source before adopting its regimen.
GlobalRPh Renal Dosing Master v7.4. Review the retrieval and revision dates attached to each source. Selecting a reference does not imply clinical verification.
