GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Vibegron tablets (Gemtesa)

Local official-label summaryBase record retrieved 2026-09-05See the evidence for this drug1 sources available - open source summaries, references and comparisons

Gemtesa

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Official source

Vibegron tablets (Gemtesa) - selected U.S. label sections

Product / population
Adult GEMTESA oral tablets.
Renal measure
eGFR in mL/min/1.73 m2

Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.

Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.

Renal impairment comments

No adjustment is recommended for eGFR 15 to below 90. Patients with eGFR below 15, with or without hemodialysis, have not been studied; use is not recommended in that setting.

Source revision: Revision not captured; retrieval date is not the revision date. | Retrieved: 2026-09-05. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=25f21d25-14f8-4fda-91f6-7aa8b68aa1c8

Scope: Local label summary; independent clinical review pending. Not a two-source validated protocol. GlobalRPh v6.6.

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Original content / product scopeVibegron tablets (Gemtesa) - selected U.S. label sections
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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=25f21d25-14f8-4fda-91f6-7aa8b68aa1c8

Product and population scope

Adult GEMTESA oral tablets.

RDM32-vibegron-gemtesa-scope · Source section: Editorial scope for the selected U.S. labelRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Vibegron tablets (Gemtesa) - selected U.S. label sections

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U.S. product labeling / DailyMed · Adult GEMTESA oral tablets.

Renal method: eGFR in mL/min/1.73 m2
Source date: Revision not captured; retrieval date is not the revision date.
Retrieved: 2026-09-05

Local label summary; independent clinical review pending. Not a two-source validated protocol.

Renal impairment comments

No adjustment is recommended for eGFR 15 to below 90. Patients with eGFR below 15, with or without hemodialysis, have not been studied; use is not recommended in that setting.

RDM32-vibegron-gemtesa-1 · Source locator: 8.6

Source-specific limits

Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.

Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.

Source identity and provenance
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=25f21d25-14f8-4fda-91f6-7aa8b68aa1c8
Retrieved
2026-09-05
DailyMed Set ID
25f21d25-14f8-4fda-91f6-7aa8b68aa1c8
Renal-function method
eGFR in mL/min/1.73 m2
Source date/version
Revision not captured; retrieval date is not the revision date.
Hash meaning
SHA-256 identifies this local summary, not original SPL XML or a label PDF.
Local summary SHA-256
29b89c3be20d6c6529cb2e0c7a35ad9441552201b4b880af16dae76449ea6357

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 0 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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=25f21d25-14f8-4fda-91f6-7aa8b68aa1c8
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
c73ea8a16fbf08440331fd49a95875755fe4040ab49a1e0f47d2970d40cbf2a5
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.

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