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1 local source card selected. Local card fingerprints checked where supplied. This is not an original-document hash, source-currency guarantee or clinical approval. Record-level cautions below are the current library's cautions, not a frozen prior version.
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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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SOVALDI - official product-specific renal limitation
Product / population
SOVALDI - official product-specific renal limitation; selected renal passages, not a complete prescribing monograph.
Renal method
eGFR in mL/min/1.73 m2; preserve body-surface-area indexing.
Source revision
Prescribing information revised December 2024.
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.
Product labeling and regimen-level HCV guidance require reconciliation
The retrieved SOVALDI label retains a severe-renal/ESRD limitation while the guideline discusses recommended sofosbuvir-containing regimens in these populations.
What to reconcile: Have HCV pharmacy/specialist review the exact regimen and companion drugs. No blended dose is generated.
DailyMed / Gilead Sciences, Inc. · SOVALDI - official product-specific renal limitation; selected renal passages, not a complete prescribing monograph.
Renal method: eGFR in mL/min/1.73 m2; preserve body-surface-area indexing. Source date: Prescribing information revised December 2024. Retrieved: 2026-09-09
Limited or unstudied renal evidence. Not studied does not mean no adjustment is required.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
The December 2024 SOVALDI prescribing information still gives no dose recommendation at eGFR <30 mL/min/1.73 m2 or ESRD, while requiring no adjustment for mild/moderate impairment. Sections 2.7 and 8.6 retain this limitation. Ribavirin and peginterferon renal instructions require separate review. Do not present the broader guideline statement about sofosbuvir-containing regimens as proof that this exact product label has changed. Severe-renal use requires specialist reconciliation of the selected regimen and sources; no blended dose is generated here.
RDM53-official-sofosbuvir-sovaldi-29291349cc-C1 · Source locator: Sections 2.7 and 8.6; label header and PI revision.
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.