VIVJOA - oteseconazole capsules
- Product / population
- VIVJOA oral oteseconazole for eligible females who are not of reproductive potential; selected official renal recheck.
- Renal measure
- MDRD eGFR; selected label prints mL/min without indexing denominator
Selected sections only; not a complete prescribing monograph or independent clinician approval.
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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.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e21d5008-800e-4417-927f-14340341865f