GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Ibrutinib oral products (Imbruvica, adult renal comments)

Local official-label summaryBase record retrieved 2026-09-05See the evidence for this drug2 sources available - open source summaries, references and comparisons

Imbruvica

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Official source

Ibrutinib oral products (Imbruvica, adult renal comments) - selected U.S. label sections

Product / population
Adult renal comments from the selected IMBRUVICA label; this entry does not provide a formulation conversion.
Renal measure
Cockcroft-Gault CrCl in mL/min in PK section

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 pharmacokinetic evidence

The selected label reports no exposure effect in mild or moderate impairment with CrCl above 25 mL/min. Data are absent for severe impairment below 25 mL/min and for dialysis. The exact boundary at 25 is not resolved by the wording of that section and is not assigned a guessed regimen.

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=0dfd0279-ff17-4ea9-89be-9803c71bab44

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

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Evidence sources and renal implications

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Official product label

Ibrutinib oral products (Imbruvica, adult renal comments) - selected U.S. label sections

Adult renal comments from the selected IMBRUVICA label; this entry does not provide a formulation conversion.

Renal method: Cockcroft-Gault CrCl in mL/min in PK section
Retrieved: 2026-09-05

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GlobalRPh RX List

GlobalRPh RX List - IMBRUVICA

Pharmacokinetic observation only. A drug-exposure observation is not itself a dose recommendation.

Adult IMBRUVICA oral products; selected renal pharmacokinetics, not an all-indication dose schedule.

Renal method: Cockcroft-Gault CrCl in mL/min.
Retrieved: 2026-09-07

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Renal dosing and precautions

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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.
Official source

Ibrutinib oral products (Imbruvica, adult renal comments) - selected U.S. label sections

Adult renal comments from the selected IMBRUVICA label; this entry does not provide a formulation conversion.

Method: Cockcroft-Gault CrCl in mL/min in PK section

Renal pharmacokinetic evidenceRead this complete source summary

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Original content / product scopeIbrutinib oral products (Imbruvica, adult renal comments) - selected U.S. label sectionsGlobalRPh RX List - IMBRUVICA
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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.
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=0dfd0279-ff17-4ea9-89be-9803c71bab44

Product and population scope

Adult renal comments from the selected IMBRUVICA label; this entry does not provide a formulation conversion.

RDM32-ibrutinib-imbruvica-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

Ibrutinib oral products (Imbruvica, adult renal comments) - selected U.S. label sections

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U.S. product labeling / DailyMed · Adult renal comments from the selected IMBRUVICA label; this entry does not provide a formulation conversion.

Renal method: Cockcroft-Gault CrCl in mL/min in PK section
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 pharmacokinetic evidence

The selected label reports no exposure effect in mild or moderate impairment with CrCl above 25 mL/min. Data are absent for severe impairment below 25 mL/min and for dialysis. The exact boundary at 25 is not resolved by the wording of that section and is not assigned a guessed regimen.

RDM32-ibrutinib-imbruvica-1 · Source locator: 12.3, Specific Populations

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=0dfd0279-ff17-4ea9-89be-9803c71bab44
Retrieved
2026-09-05
DailyMed Set ID
0dfd0279-ff17-4ea9-89be-9803c71bab44
Renal-function method
Cockcroft-Gault CrCl in mL/min in PK section
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
57bc905aa653cab817326172e21299d8527783001c5a56c9fb56c31737dde83c
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

GlobalRPh RX List - IMBRUVICA

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GlobalRPh-hosted RX List · Adult IMBRUVICA oral products; selected renal pharmacokinetics, not an all-indication dose schedule.

Renal method: Cockcroft-Gault CrCl in mL/min.
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.
Pharmacokinetic observation only. A drug-exposure observation is not itself a dose recommendation.

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

In the selected pharmacokinetic section, mild/moderate impairment with Cockcroft-Gault CrCl above 25 mL/min did not materially affect exposure. Data are absent below 25 mL/min and in dialysis. These statements do not establish a dose for unstudied patients. Exactly 25 mL/min is not assigned by the quoted greater-than/less-than wording; clarify the boundary rather than rounding it into a band.

RDM43-rxlist-ibrutinib-imbruvica-300784c43d-C1 · Source locator: Selected Dosage / Renal Impairment / Warnings sections; see source-specific qualifications in this summary.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/imbruvica-drug/
Retrieved
2026-09-07
Renal-function method
Cockcroft-Gault CrCl in mL/min.
Source date/version
Source revision date not established in selected retrieval.
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
f7216aca754d477e27f42fe67c4a459098432ac4a9ff49ca9b31164d84b6cb8c

Provenance and preservation

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.

Original source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0dfd0279-ff17-4ea9-89be-9803c71bab44
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
681ee55a6aa337eb4b10450bca82be78772db83bfdad598e5e19a1cb87537be3
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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