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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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VIVJOA - official renal discrepancy recheck
Product / population
VIVJOA - official renal discrepancy recheck; selected renal passages, not a complete prescribing monograph.
Renal method
Source prints eGFR in mL/min; BSA indexing is not explicitly established and is not silently relabeled.
Source revision
Previously established PI revision April 2022; section 8.6 and header rechecked in v5.0.
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.
VIVJOA: severe-renal source disagreement is not resolved by a date assumption
The RX mirror permits severe impairment; retrieved DailyMed and manufacturer safety wording do not. The mirror prints April 2024; DailyMed has a January 2026 header but an April 2022 PI revision.
What to reconcile: Hold the more permissive RX instruction for exact-label reconciliation. Do not treat header/retrieval dates as new label revisions or prescribe from the disputed extract.
VIVJOA: official recheck retains the disagreement hold
The current RX recheck remains permissive in severe impairment; the retrieved DailyMed renal section remains restrictive. Header and retrieval dates do not establish a new prescribing-information revision.
What to reconcile: Continue holding the disputed RX instruction. This release does not claim exact controlling-label reconciliation.
Official restriction rechecked; the historical mirror conflict stays open
The official label still does not recommend severe impairment or ESRD with or without dialysis. The RX mirror could not be reliably re-read in this pass.
What to reconcile: Retain the historical discrepancy and the printed renal-measure limitation. Reproductive-potential restrictions remain separate.
DailyMed / Mycovia Pharmaceuticals, Inc. · VIVJOA - official renal discrepancy recheck; selected renal passages, not a complete prescribing monograph.
Renal method: Source prints eGFR in mL/min; BSA indexing is not explicitly established and is not silently relabeled. Source date: Previously established PI revision April 2022; section 8.6 and header rechecked in v5.0. Retrieved: 2026-09-09
Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
Rechecked section 8.6 still does not recommend VIVJOA in severe renal impairment (MDRD eGFR 15-29 mL/min) or ESRD below 15, with or without dialysis. No adjustment is recommended at 30-89. The January 8, 2026 DailyMed header update does not itself establish a revised prescribing-information date. The conflicting permissive RX extract remains held; this recheck does not authorize severe-renal use or claim reconciliation of the mirror to a new FDA revision.
RX disagreement remains open; no FDA revision-history closure claimed.
Identity check: DailyMed labeler Mycovia Pharmaceuticals, Inc.. Current archive version 5 published 2026-01-09. This archive date is separate from the prescribing-information revision and does not itself prove that renal instructions changed. Raw SPL XML was not independently downloaded or hashed.
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.