GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Ivosidenib tablets (Tibsovo)

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

Tibsovo

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Official source

Ivosidenib tablets (Tibsovo) - selected U.S. label sections

Product / population
TIBSOVO oral tablets; retain the underlying indication-specific treatment plan.
Renal measure
MDRD 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 modification of the starting dose is recommended for mild or moderate impairment, with MDRD eGFR at least 30. Pharmacokinetics and safety below 30 or with hemodialysis are unknown. Consider risks and potential benefits before use in severe impairment or dialysis.

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=65d254c0-67ad-42c4-b972-ad463b755b2d

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

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Official product label

Ivosidenib tablets (Tibsovo) - selected U.S. label sections

TIBSOVO oral tablets; retain the underlying indication-specific treatment plan.

Renal method: MDRD eGFR in mL/min/1.73 m2
Retrieved: 2026-09-05

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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.

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Original content / product scopeIvosidenib tablets (Tibsovo) - 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=65d254c0-67ad-42c4-b972-ad463b755b2d

Product and population scope

TIBSOVO oral tablets; retain the underlying indication-specific treatment plan.

RDM32-ivosidenib-tibsovo-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

Ivosidenib tablets (Tibsovo) - selected U.S. label sections

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U.S. product labeling / DailyMed · TIBSOVO oral tablets; retain the underlying indication-specific treatment plan.

Renal method: MDRD 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 modification of the starting dose is recommended for mild or moderate impairment, with MDRD eGFR at least 30. Pharmacokinetics and safety below 30 or with hemodialysis are unknown. Consider risks and potential benefits before use in severe impairment or dialysis.

RDM32-ivosidenib-tibsovo-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=65d254c0-67ad-42c4-b972-ad463b755b2d
Retrieved
2026-09-05
DailyMed Set ID
65d254c0-67ad-42c4-b972-ad463b755b2d
Renal-function method
MDRD 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
a0b372d9093a7e17fe5588b83713c675ec411a18ac5924d61c6f17bcfc811fd1

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=65d254c0-67ad-42c4-b972-ad463b755b2d
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
60a8e9300af93fb98d141a3774018cd940b2e5b2a10571efe439d15d5fa7b122
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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