GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Axitinib tablets (Inlyta)

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

Inlyta

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Official source

Axitinib tablets (Inlyta) - selected U.S. label sections

Product / population
Adult INLYTA oral tablets.
Renal measure
Creatinine clearance in mL/min

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

Population PK analysis did not show a significant clearance difference with baseline CrCl 15-89 mL/min, and no initial dose adjustment is needed for mild through severe impairment. Use caution in ESRD with CrCl below 15. A dedicated renal-impairment trial was not conducted.

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=84137882-e000-47da-bd5b-fa76ab3c76f9

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

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Original content / product scopeAxitinib tablets (Inlyta) - 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=84137882-e000-47da-bd5b-fa76ab3c76f9

Product and population scope

Adult INLYTA oral tablets.

RDM32-axitinib-inlyta-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

Axitinib tablets (Inlyta) - selected U.S. label sections

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

Renal method: Creatinine clearance in mL/min
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

Population PK analysis did not show a significant clearance difference with baseline CrCl 15-89 mL/min, and no initial dose adjustment is needed for mild through severe impairment. Use caution in ESRD with CrCl below 15. A dedicated renal-impairment trial was not conducted.

RDM32-axitinib-inlyta-1 · Source locator: 8.7; 12.3

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=84137882-e000-47da-bd5b-fa76ab3c76f9
Retrieved
2026-09-05
DailyMed Set ID
84137882-e000-47da-bd5b-fa76ab3c76f9
Renal-function method
Creatinine clearance in mL/min
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
cc0a24e425bca26a40170a65d72952e054da68080837682bf0875cfaf3120a81

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=84137882-e000-47da-bd5b-fa76ab3c76f9
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
2dbcf0aed10258bb5f6bb8f3bf27b08df0e536e3abbdfd2c1b161f21a001431c
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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