REZDIFFRA - official renal evidence recheck
- Product / population
- REZDIFFRA - official renal evidence recheck; selected renal passages, not a complete prescribing monograph.
- Renal measure
- eGFR, mL/min/1.73 m2; preserve body-surface-area indexing. MDRD for mild/moderate analysis; CKD-EPI for the severe-impairment study.
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.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e67ea09f-a840-439c-86c8-f98585f978b2