Confirm the product, indication and renal measure. The selected summary is not a complete prescribing monograph.
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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.
1 additional source qualifications - review before use
The retained RX renal statement comes from an old UKONIQ label. The separately stored FDA safety communication directs clinicians to stop prescribing after approval withdrawal.
Before applying: Do not interpret the historical renal statement as current treatment advice. Any exceptional access must be independently established; this tool neither verifies nor authorizes such access.
Also check: FDA withdrawal overrides a historical no-adjustment statement
Rxlist source
GlobalRPh RX List - Ukoniq
Product / population
Withdrawn U.S. approval. Historical oral umbralisib label extract, not current treatment advice.
Renal measure
Cockcroft-Gault CLcr in mL/min; historical label
RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.
Renal dosing, restrictions and evidence limits
HISTORICAL LABEL CONTENT ONLY. The archived RX text says no renal dose adjustment for Cockcroft-Gault CLcr 30-89 mL/min and states severe impairment below 30 was not studied. It does not establish a dialysis schedule. This retained renal statement must not be treated as a recommendation to prescribe UKONIQ: read the separately stored FDA withdrawal alert before considering the old source.
Source revision: Source revision date not established in selected retrieval. | Retrieved: 2026-09-07. Retrieval date is not the revision date.
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.
Source presence is not independent validation. A label mirror is not a second independent source; review the original reference and exact formulation.
Important product / source limitation: Withdrawn U.S. approval - historical content only. FDA instructs clinicians to stop prescribing UKONIQ. Read the FDA safety source below.
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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.
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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.
Select two distinct source versions. The complete stored summaries will appear below.
Source-by-source comparison
These protocols may disagree and may apply to different settings. This view does not reconcile or endorse a patient-specific regimen.
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.
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.
historical source restriction
FDA withdrawal overrides a historical no-adjustment statement
The retained RX renal statement comes from an old UKONIQ label. The separately stored FDA safety communication directs clinicians to stop prescribing after approval withdrawal.
How to use this: Do not interpret the historical renal statement as current treatment advice. Any exceptional access must be independently established; this tool neither verifies nor authorizes such access.
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.
Rxlist source
GlobalRPh RX List - Ukoniq
Withdrawn U.S. approval. Historical oral umbralisib label extract, not current treatment advice.
Method: Cockcroft-Gault CLcr in mL/min; historical label
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.
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.
GlobalRPh-hosted RX List · Withdrawn U.S. approval. Historical oral umbralisib label extract, not current treatment advice.
Renal method: Cockcroft-Gault CLcr in mL/min; historical label Source date: Source revision date not established in selected retrieval. Retrieved: 2026-09-07
Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
Historical product / current restriction. Historical renal instructions do not establish current prescribing eligibility. Read the regulatory caution.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
HISTORICAL LABEL CONTENT ONLY. The archived RX text says no renal dose adjustment for Cockcroft-Gault CLcr 30-89 mL/min and states severe impairment below 30 was not studied. It does not establish a dialysis schedule. This retained renal statement must not be treated as a recommendation to prescribe UKONIQ: read the separately stored FDA withdrawal alert before considering the old source.
RDM36-rxlist-umbralisib-ukoniq-historical-5217ec50fc-C1 · Source locator: Use in specific populations: renal impairment; specific populations PK.
U.S. Food and Drug Administration · U.S. FDA regulatory alert for umbralisib; no current-use endorsement.
Renal method: Regulatory safety restriction; renal adjustment does not override withdrawal Source date: June 1, 2022 Retrieved: 2026-09-07
Historical product / current restriction. Historical renal instructions do not establish current prescribing eligibility. Read the regulatory caution.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
The FDA June 1, 2022 communication states that UKONIQ approval was withdrawn because a possible increased risk of death outweighed its benefits. FDA instructs clinicians to stop prescribing it and switch to alternatives. Historical renal-dose language does not reverse that regulatory action. The communication mentioned possible expanded access in limited circumstances; this summary does not establish that an expanded-access pathway is currently available.
RDM36-professional-umbralisib-ukoniq-historical-082a612d2e-C1 · Source locator: June 1, 2022 Drug Safety Communication: FDA action and clinician instructions.
Additional summaries stored on this page: 0 official-label, 1 RX List, 1 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.