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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.
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REZDIFFRA - official renal evidence recheck
Product / population
REZDIFFRA - official renal evidence recheck; selected renal passages, not a complete prescribing monograph.
Renal method
eGFR, mL/min/1.73 m2; preserve body-surface-area indexing. MDRD for mild/moderate analysis; CKD-EPI for the severe-impairment study.
Source revision
Prescribing information revised July 2026.
Retrieved
2026-09-09
Local review status
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Documented differences and cautions on this drug
All record notes are retained here, including notes about sources not selected in this review.
REZDIFFRA: March 2024 mirror versus July 2026 official renal evidence
The older mirror leaves severe impairment unstudied. The newer official section addresses severe impairment explicitly. This is a dated evidence difference, not two interchangeable current instructions.
What to reconcile: Use the current official renal section in its full product context. Preserve each study method and do not extend a nondialysis finding to an unsupported dialysis regimen.
DailyMed / Madrigal Pharmaceuticals, Inc. · REZDIFFRA - official renal evidence recheck; selected renal passages, not a complete prescribing monograph.
Renal method: eGFR, mL/min/1.73 m2; preserve body-surface-area indexing. MDRD for mild/moderate analysis; CKD-EPI for the severe-impairment study. Source date: Prescribing information revised July 2026. Retrieved: 2026-09-09
No adjustment within stated limits. This does not establish dosing outside the studied renal range or population.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
Section 8.6 recommends the same dosage for mild, moderate and severe renal impairment. Section 12.3 now includes a severe-impairment study using CKD-EPI eGFR <30 mL/min/1.73 m2; its mild/moderate analysis uses MDRD. Preserve those method differences. The renal statement does not remove actual-body-weight dosing, CYP2C8 interaction modifications, statin limits or hepatic restrictions. The selected sections establish no separate dialysis regimen. This dated recheck supplements the existing local record; it is not a claim that the earlier local dose was wrong.
RDM52-official-resmetirom-rezdiffra-be45eea5d9-C1 · Source locator: Sections 8.6 and 12.3; sections 2.1-2.2 for body weight and interactions; PI revision and label header.
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 v6.6 | RDM66-DIRECT-PHP-20260911 | Local library date 2026-09-11. Selected-card identity does not imply clinical verification.