GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Oteseconazole - VIVJOA capsules

VIVJOA / Oteseconazole

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

Cautions / source differences (3)
Review first - source-specific qualification

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.

Before applying: Retain the historical discrepancy and the printed renal-measure limitation. Reproductive-potential restrictions remain separate.

Evidence for this qualification

Source-specific qualification; independent clinician review pending.

Confirm the product, indication and renal measure. The selected summary is not a complete prescribing monograph.

Choose a source to read (4)

Display order is not a clinical ranking. Date of retrieval is not the label revision date. Sources are never merged into one regimen. Other sources and conflicts remain below.

2 additional source qualifications - review before use
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.

Before applying: 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.

Before applying: Continue holding the disputed RX instruction. This release does not claim exact controlling-label reconciliation.

Also check: VIVJOA: severe-renal source disagreement is not resolved by a date assumption; VIVJOA: official recheck retains the disagreement hold

Official source

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.

Exact DailyMed HTML identity and named sections checked. Raw SPL XML, original document hash and complete revision history were not obtained.

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 revision: 4/2022 | Retrieved: 2026-09-10. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e21d5008-800e-4417-927f-14340341865f

Scope: Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph. GlobalRPh v6.6.

Full source card / provenance

All sources, comparison tools and evidence navigation
Source-first renal review

Evidence sources and renal implications

Choose a source to jump directly to its locally stored result. Qualitative precautions and evidence gaps remain visible even when no numerical clearance schedule is supplied.

Read 3 source difference / applicability notes

Official product label

VIVJOA - official renal restriction summary

Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.

VIVJOA - official renal restriction summary; selected source sections only, not a complete prescribing monograph.

Renal method: Source prints eGFR in mL/min without a BSA denominator; indexing is not established and is not silently relabeled.
Retrieved: 2026-09-09

Official product label

VIVJOA - official renal discrepancy recheck

Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.

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.
Retrieved: 2026-09-09

Official product label

VIVJOA - oteseconazole capsules

Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.

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
Retrieved: 2026-09-10

GlobalRPh RX List

GlobalRPh RX List - VIVJOA

Limited or unstudied renal evidence. Not studied does not mean no adjustment is required.

Oteseconazole - VIVJOA capsules; selected source sections only, not a complete prescribing monograph.

Renal method: Source prints eGFR in mL/min without a BSA denominator; indexing is not established and is not silently relabeled.
Retrieved: 2026-09-09

Source presence is not independent validation. A label mirror is not a second independent source; review the original reference and exact formulation.

Product / population check

Confirm the exact formulation before using a renal source

These links compare product identities, not interchangeable doses. A selected summary is not a complete prescribing monograph.

Source-specific review points

Read the attributed comparison notes and source cards below. No conflict has been silently adjudicated.

Source-quality holds
Find text within this drug
Find a term without leaving this drug

Search the stored clinical text

Locate a word or phrase within this drug's source summaries. Choose all sources or one source to focus the search. The selection never hides warnings or source text, changes a dose, or proves that a renal finding is absent.

Find:

Enter at least two characters. Searches stay on this page and are not saved or sent.

All source summaries, original wording and provenance
Before applying a renal protocol

Check the setting. Compare whole sources.

No patient-specific dose is calculated. Context choices only display reminders; they do not validate, hide or change any regimen.

Share a reproducible source review

Choose sources below, then open a print-ready comparison with product scope, renal method, dates and cautions. Links can pin the exact local cards; they never contain patient values or choose a dose.

Open / share selected sources

Select two distinct source versions. The complete stored summaries will appear below.

Build a source-review outline for documentation

This creates a blank decision outline with the source identities you select, not a dose recommendation or completed clinical assessment. No patient fields are collected, saved or sent. Complete the clinical decisions in your approved documentation system.

Choose one or two sources above or use the source checkboxes below.

Renal-context checklist: population, kidney trend and dialysis

These prompts are a reading aid, not a prescription checklist or proof that all requirements have been met. No selections are stored or sent to a server.

Read the exact source scope, renal metric and date before selecting a row. No applicability assessment has been performed.

See source-specific renal methods and the clinical interpretation guide for the supporting context.

Read before choosing a regimen

Source differences and product cautions

Search differences across all drugs

These are specific issues found during source review, not an automated judgment that one source is universally correct. A label mirror and its original label are not independent evidence.

guideline difference

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.

How to use this: 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.

Source-specific interpretation; independent clinician adjudication pending.

guideline difference

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.

How to use this: Continue holding the disputed RX instruction. This release does not claim exact controlling-label reconciliation.

Source-specific interpretation; independent clinician adjudication pending.

official recheck unresolved mirror

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.

How to use this: Retain the historical discrepancy and the printed renal-measure limitation. Reproductive-potential restrictions remain separate.

Source-specific interpretation; independent clinician adjudication pending.

Go directly to the relevant source section

Renal dosing and precautions

Choose a source, then jump to its renal or dialysis section. These links locate stored text; they do not merge regimens or certify that sources agree.

New source summary - independent clinical review pending. Summaries of the identified label sections are included locally. Source import and numeric transcription checks are not independent two-reference validation. Do not treat this card as an approved institutional dosing protocol.

No dialysis or renal heading shown? Read the complete source summary. Absence of a heading is not evidence that dose adjustment is unnecessary.

Compare or copy source versions

All content below is stored locally. Read a whole source version; do not combine its dose with another source's interval, renal metric or dialysis assumptions.

Choose two source checkboxes below.
Exact product and population matter. This added page contains locally stored, source-specific clinical summaries. Historical handbook information, when present, is identified separately and may conflict with U.S. labeling. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.
Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://globalrph.com/rx-list/vivjoa-drug/

Exact product and population

Oteseconazole - VIVJOA capsules; selected source sections only, not a complete prescribing monograph.

RDM49-SCOPE-oteseconazole-vivjoa · Source section: Selected source product scopeRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

VIVJOA - official renal restriction summary

Open original reference

Open / share this exact local source

DailyMed / Mycovia Pharmaceuticals, Inc. · VIVJOA - official renal restriction summary; selected source sections only, not a complete prescribing monograph.

Renal method: Source prints eGFR in mL/min without a BSA denominator; indexing is not established and is not silently relabeled.
Source date: Prescribing information revised April 2022.
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

No adjustment is recommended for mild/moderate impairment, defined here as MDRD eGFR 30-89 mL/min. Use in severe impairment (15-29) or ESRD (<15), with or without dialysis, is not recommended because of insufficient safety information. VIVJOA is contraindicated in females of reproductive potential and in pregnant or lactating women. The retrieved DailyMed header was updated January 8, 2026, while its PI retains an April 2022 revision. Neither retrieval nor header date establishes a newly revised renal instruction.

RDM49-official-oteseconazole-vivjoa-07fd066c0a-C1 · Source locator: Section 8.6, lines 408-410; contraindications; header update and PI revision.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e21d5008-800e-4417-927f-14340341865f
Retrieved
2026-09-09
Exact label title
VIVJOA - official renal restriction summary
DailyMed Set ID
e21d5008-800e-4417-927f-14340341865f
Labeler
Mycovia Pharmaceuticals, Inc.
DailyMed page updated
2026-01-08
Label revision
Prescribing information revised April 2022.
FDA application
NDA215888
Renal-function method
Source prints eGFR in mL/min without a BSA denominator; indexing is not established and is not silently relabeled.
Source date/version
Prescribing information revised April 2022.
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
cd7b4fea5b01e17e874dc49e3d538d3172650af7d66be8cefabfb0e3e1484e49
Official

VIVJOA - official renal discrepancy recheck

Open original reference

Open / share this exact local source

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.

RDM50-official-oteseconazole-vivjoa-07fd066c0a-C1 · Source locator: Section 8.6, lines 408-410; header date, line 164.

Source-specific limits

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.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e21d5008-800e-4417-927f-14340341865f
Retrieved
2026-09-09
Exact label title
VIVJOA- oteseconazole capsule
DailyMed Set ID
e21d5008-800e-4417-927f-14340341865f
Labeler
Mycovia Pharmaceuticals, Inc.
DailyMed page updated
2026-01-08
Label revision
Previously established PI revision April 2022; section 8.6 and header rechecked in v5.0.
Archive publication date
2026-01-09
SPL version
5
FDA application
NDA215888
Renal-function method
Source prints eGFR in mL/min; BSA indexing is not explicitly established and is not silently relabeled.
Source date/version
Previously established PI revision April 2022; section 8.6 and header rechecked in v5.0.
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
7535395163941b357dc0d2065b9cab2feac3d90f0aebd5c5ec9f2c782379d653
Official

VIVJOA - oteseconazole capsules

Open original reference

Open / share this exact local source

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.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e21d5008-800e-4417-927f-14340341865f
Retrieved
2026-09-10
Exact label title
VIVJOA - oteseconazole capsules
DailyMed Set ID
e21d5008-800e-4417-927f-14340341865f
Labeler
Mycovia Pharmaceuticals, Inc.
Label revision
4/2022
Renal-function method
MDRD eGFR; selected label prints mL/min without indexing denominator
Source date/version
4/2022
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
c43fb1e925de788e487619675a7063efc2b7b71fc1980276903a02fdf9e11f54
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

GlobalRPh RX List - VIVJOA

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · Oteseconazole - VIVJOA capsules; selected source sections only, not a complete prescribing monograph.

Renal method: Source prints eGFR in mL/min without a BSA denominator; indexing is not established and is not silently relabeled.
Source date: RX page prints April 2024; not independently reconciled to an FDA label revision.
Retrieved: 2026-09-09

Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
Source recheck unresolved. Prior follow-up retrieval/version warning retained; not resolved by v6.0. Read source-review status
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

DISPUTED SOURCE: the RX mirror, printing an April 2024 revision, states no adjustment for MDRD eGFR 15-89 mL/min and describes ESRD effects as unknown. This conflicts with the separately retrieved DailyMed label and manufacturer safety page, which do not recommend severe-renal/ESRD use. Retain this extract solely to document the disagreement, not to authorize treatment at eGFR <30. BSA indexing is not explicitly printed in these units.

RDM49-rxlist-oteseconazole-vivjoa-fefed28fb0-C1 · Source locator: Renal impairment, lines 176-178; printed revision, line 73.

Source-specific limits

Prescribing-source hold: severe-renal discrepancy unresolved. Read the official card and comparison.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/vivjoa-drug/
Retrieved
2026-09-09
Renal-function method
Source prints eGFR in mL/min without a BSA denominator; indexing is not established and is not silently relabeled.
Source date/version
RX page prints April 2024; not independently reconciled to an FDA label revision.
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
be46bb986ebecaace880f505ba85a6747a9724568dfc8047e50e25845d98cbd9

Provenance and preservation

Additional summaries stored on this page: 3 official-label, 1 RX List, 0 professional, 0 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.

Original source
https://globalrph.com/rx-list/vivjoa-drug/
Source retrieval
2026-09-09. This is not the source publication or label revision date.
Original source type
rxlist summary
Local text SHA-256
44252331018c119febf637fb41b20768147dcca8c90c6d0c1a69567853d31d61
Import versus clinical validation
Source-section locators identify where retained content came from. A source-section identifier does not assert that every numeric statement has been independently corroborated. The local text hash is not a hash of original HTML, an FDA PDF or SPL XML.

This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.

Read the full coverage report