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1 additional source qualifications - review before use
The renal reduction includes mild impairment and uses actual body weight in Cockcroft-Gault. The current retrieved regimen uses 125 mg capsules with a low-fat meal.
Before applying: Do not mix the retrieved regimen with older fasting instructions or calculate combined hepatic/interaction reductions.
Also check: TURALIO: renal band, capsule strength and meal instructions must match
Official source
TURALIO - official renal dose and food check
Product / population
TURALIO - official renal dose and food check; selected renal passages, not a complete prescribing monograph.
Renal measure
Cockcroft-Gault creatinine clearance (CrCl), mL/min. Actual body weight.
Identity check: DailyMed labeler Daiichi Sankyo Inc.. Current archive version 8 published 2025-01-20. 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.
Renal dosing, restrictions and evidence limits
For Cockcroft-Gault CrCl 15-89 mL/min using actual body weight, the official renal regimen is 125 mg in the morning and 250 mg in the evening, with a low-fat meal. The label defines low fat as approximately 11-14 g total fat and lists 125 mg capsules. Avoid high-fat meals because exposure and toxicity can increase. The renal instruction is distinct from the usual 250 mg twice-daily regimen and from hepatic or interacting-drug modifications.
Source revision: Prescribing information revised January 2025. | Retrieved: 2026-09-09. Retrieval date is not the revision date.
All sources, comparison tools and evidence navigation
Source-first renal review
Evidence sources and renal implications
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Renal-context checklist: population, kidney trend and dialysis
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formulation scope
TURALIO: renal band, capsule strength and meal instructions must match
The renal reduction includes mild impairment and uses actual body weight in Cockcroft-Gault. The current retrieved regimen uses 125 mg capsules with a low-fat meal.
How to use this: Do not mix the retrieved regimen with older fasting instructions or calculate combined hepatic/interaction reductions.
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.
Official source
TURALIO - official renal dose and food check
TURALIO - official renal dose and food check; selected renal passages, not a complete prescribing monograph.
Method: Cockcroft-Gault creatinine clearance (CrCl), mL/min. Actual body weight.
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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.
DailyMed / Daiichi Sankyo Inc. · TURALIO - official renal dose and food check; selected renal passages, not a complete prescribing monograph.
Renal method: Cockcroft-Gault creatinine clearance (CrCl), mL/min. Actual body weight. Source date: Prescribing information revised January 2025. Retrieved: 2026-09-09
Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
For Cockcroft-Gault CrCl 15-89 mL/min using actual body weight, the official renal regimen is 125 mg in the morning and 250 mg in the evening, with a low-fat meal. The label defines low fat as approximately 11-14 g total fat and lists 125 mg capsules. Avoid high-fat meals because exposure and toxicity can increase. The renal instruction is distinct from the usual 250 mg twice-daily regimen and from hepatic or interacting-drug modifications.
RDM50-official-pexidartinib-turalio-6c505fced1-C1 · Source locator: Sections 2.1 and 2.5, lines 329-331 and 399-401; dosage form, line 197.
Source-specific limits
Identity check: DailyMed labeler Daiichi Sankyo Inc.. Current archive version 8 published 2025-01-20. 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.
GlobalRPh-hosted RX List · Pexidartinib - TURALIO 125 mg capsules; selected renal passages, not a complete prescribing monograph.
Renal method: Cockcroft-Gault creatinine clearance (CrCl), mL/min. The source explicitly specifies actual body weight. Source date: Source revision date not established in selected retrieval. 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.
Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
For Cockcroft-Gault CrCl 15-89 mL/min using actual body weight, give 125 mg in the morning and 250 mg in the evening with a low-fat meal. This renal reduction includes mild impairment. Preserve the 125 mg capsule presentation and food requirement; do not combine this regimen with an older fasting regimen. The selected passage supplies no dose below CrCl 15 or for dialysis. Hepatic impairment and CYP3A/UGT interactions have separate instructions that cannot be combined by arithmetic. Full hepatotoxicity monitoring and the product safety program remain essential.
Additional summaries stored on this page: 1 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.
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.