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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 - oteseconazole capsules
Product / population
VIVJOA oral oteseconazole for eligible females who are not of reproductive potential; selected official renal recheck.
Renal method
MDRD eGFR; selected label prints mL/min without indexing denominator
Source revision
4/2022
Retrieved
2026-09-10
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 oral oteseconazole for eligible females who are not of reproductive potential; selected official renal recheck.
Renal method: MDRD eGFR; selected label prints mL/min without indexing denominator Source date: 4/2022 Retrieved: 2026-09-10
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
No adjustment is recommended for mild/moderate impairment, MDRD eGFR 30-89 as printed in the label. Use is not recommended with severe impairment (15-29) or ESRD (below 15), with or without dialysis, because safety data are insufficient.
The subsection prints mL/min without the indexing denominator despite naming MDRD; retain that source limitation rather than silently substituting Cockcroft-Gault. The official restriction remains confirmed. The RX mirror was not reliably re-read in this pass, so its historical disagreement is not closed. Reproductive-potential, pregnancy and lactation contraindications remain separate.
RDM57-official-oteseconazole-vivjoa-07fd066c0a-C1 · Source locator: Sections 4 and 8.6
Source-specific limits
Selected sections only; not a complete prescribing monograph or independent clinician approval.
Exact DailyMed HTML identity and named sections checked. Raw SPL XML, original document hash and complete revision history were not obtained.
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.