GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Belinostat (BELEODAQ)

Beleodaq

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

Cautions / source differences (2)
Review first - source-specific qualification

Current renal paragraphs agree; preserve the dated disagreement

The September 2026 RX retrieval now matches the official renal section. The older saved mirror gap remains historical, not the current retrieved wording.

Before applying: Read the new sources first. A separate UGT1A1-inhibitor rule matters at the reduced dose; concordance is not full clinical approval.

Evidence for this qualification

Source-specific qualification; independent clinician review pending.

Confirm the product, indication and renal measure. The selected summary is not a complete prescribing monograph.

Choose a source to read (4)

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
Newer label supplies a renal dose absent from the RX version

The older RX entry has a renal evidence gap; the April 2025 label supplies a moderate-impairment reduction and severe-impairment avoidance.

Before applying: Read the newer official-label renal section first. Do not use the older gap to negate the updated restriction.

Also check: Newer label supplies a renal dose absent from the RX version

Official source

DailyMed / BELEODAQ exact product label

Product / population
BELEODAQ IV; selected renal sections rechecked in September 2026. Earlier source snapshots remain separately visible.
Renal measure
CrCl, mL/min; equation not named in selected renal subsection

Exact DailyMed HTML label identity and selected named sections checked. A page update is not proof that renal instructions changed.

No raw SPL XML, original XML hash or separate Drugs@FDA revision-history review was performed.

Renal dosing, restrictions and evidence limits

Section 2.4 specifies 500 mg/m2 IV over 30 minutes once daily on days 1-5 of a 21-day cycle for CrCl 30 to below 60 mL/min. Avoid below 30; no adjustment for 60 to below 90. The current mirror's selected renal wording agrees.

Section 2.6 separately matters: when the starting dose is already 500 mg/m2 and a UGT1A1 inhibitor cannot be avoided, the table directs interruption during inhibitor use and resumption after five inhibitor half-lives, rather than another simple percentage reduction. Review hepatic, genotype and toxicity modifications separately.

Source revision: 4/2025 | Retrieved: 2026-09-10. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e8ef36b-71fa-4492-a16f-577d5f7d111d

Scope: Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph. GlobalRPh v6.6.

Full source card / provenance

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.

Read 2 source difference / applicability notes

Official product label

BELEODAQ - belinostat injection

Adults with relapsed/refractory peripheral T-cell lymphoma; IV belinostat. Selected renal dose section only.

Renal method: CrCl, mL/min; equation not named in selected subsection.
Retrieved: 2026-09-07

Official product label

DailyMed / BELEODAQ exact product label

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

BELEODAQ IV; selected renal sections rechecked in September 2026. Earlier source snapshots remain separately visible.

Renal method: CrCl, mL/min; equation not named in selected renal subsection
Retrieved: 2026-09-10

GlobalRPh RX List

GlobalRPh RX List - Beleodaq

Limited or unstudied renal evidence. Not studied does not mean no adjustment is required.

IV belinostat; older RX List renal statement. Compare with the separately presented newer label.

Renal method: CrCl, mL/min.
Retrieved: 2026-09-07

GlobalRPh RX List

GlobalRPh RX List - BELEODAQ

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

BELEODAQ IV; selected renal sections rechecked in September 2026. Earlier source snapshots remain separately visible.

Renal method: CrCl, mL/min; equation not named in selected renal subsection
Retrieved: 2026-09-10

Source presence is not independent validation. A label mirror is not a second independent source; review the original reference and exact formulation.

Product / population check

Confirm the exact formulation before using a renal source

These links compare product identities, not interchangeable doses. A selected summary is not a complete prescribing monograph.

Source-specific review points

Read the attributed comparison notes and source cards below. No conflict has been silently adjudicated.

Source-quality holds
Find text within this drug
Find a term without leaving this drug

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.

Find:

Enter at least two characters. Searches stay on this page and are not saved or sent.

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.

Open / share selected sources

Select two distinct source versions. The complete stored summaries will appear below.

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.

See source-specific renal methods and the clinical interpretation guide for the supporting context.

Read before choosing a regimen

Source differences and product cautions

Search differences across all drugs

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.

label version

Newer label supplies a renal dose absent from the RX version

The older RX entry has a renal evidence gap; the April 2025 label supplies a moderate-impairment reduction and severe-impairment avoidance.

How to use this: Read the newer official-label renal section first. Do not use the older gap to negate the updated restriction.

Source difference identified; final patient-specific adjudication required.

source recheck and interaction

Current renal paragraphs agree; preserve the dated disagreement

The September 2026 RX retrieval now matches the official renal section. The older saved mirror gap remains historical, not the current retrieved wording.

How to use this: Read the new sources first. A separate UGT1A1-inhibitor rule matters at the reduced dose; concordance is not full clinical approval.

Source-specific interpretation; independent clinician adjudication pending.

Go directly to the relevant source section

Renal dosing and precautions

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.

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.

Choose two source checkboxes below.
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://globalrph.com/rx-list/beleodaq-drug/

Product and population scope

IV belinostat; older RX List renal statement. Compare with the separately presented newer label.

RDM33-SCOPE-belinostat-beleodaq-C1 · Source section: Exact product identity and selected populationRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

BELEODAQ - belinostat injection

Open original reference

Open / share this exact local source

DailyMed / NLM; manufacturer prescribing information · Adults with relapsed/refractory peripheral T-cell lymphoma; IV belinostat. Selected renal dose section only.

Renal method: CrCl, mL/min; equation not named in selected subsection.
Source date: Label revised April 2025
Retrieved: 2026-09-07

Locally imported selected source sections; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

At CrCl 30 to less than 60 mL/min, give 500 mg/m2 by IV infusion over 30 minutes once daily on days 1 through 5 of each 21-day cycle. Avoid use below CrCl 30. No adjustment is recommended at CrCl 60 to less than 90. The usual unadjusted regimen is 1,000 mg/m2 on the same schedule. These renal instructions do not replace UGT1A1, hepatic, interaction, or treatment-emergent toxicity modifications.

RDM33-official-belinostat-beleodaq-C1 · Source locator: Sections 2.1, 2.4 and 8.7.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e8ef36b-71fa-4492-a16f-577d5f7d111d
Retrieved
2026-09-07
Exact label title
BELEODAQ - belinostat injection
DailyMed Set ID
2e8ef36b-71fa-4492-a16f-577d5f7d111d
Label revision
Label revised April 2025
Renal-function method
CrCl, mL/min; equation not named in selected subsection.
Source date/version
Label revised April 2025
Hash meaning
SHA-256 of the local authored summary only; original HTML/PDF/SPL bytes are not bundled or hashed.
Local summary SHA-256
552e14c10999d3fa42bcd95f19e5ef5391dc367a796d683418024ef9f95a1c83
Official

DailyMed / BELEODAQ exact product label

Open original reference

Open / share this exact local source

DailyMed / Acrotech Biopharma Inc · BELEODAQ IV; selected renal sections rechecked in September 2026. Earlier source snapshots remain separately visible.

Renal method: CrCl, mL/min; equation not named in selected renal subsection
Source date: 4/2025
Retrieved: 2026-09-10

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

Section 2.4 specifies 500 mg/m2 IV over 30 minutes once daily on days 1-5 of a 21-day cycle for CrCl 30 to below 60 mL/min. Avoid below 30; no adjustment for 60 to below 90. The current mirror's selected renal wording agrees.

Section 2.6 separately matters: when the starting dose is already 500 mg/m2 and a UGT1A1 inhibitor cannot be avoided, the table directs interruption during inhibitor use and resumption after five inhibitor half-lives, rather than another simple percentage reduction. Review hepatic, genotype and toxicity modifications separately.

RDM56-official-belinostat-beleodaq-f1cae1d516-C1 · Source locator: Sections 2.4, 2.5-2.6 and 8.7

Source-specific limits

Exact DailyMed HTML label identity and selected named sections checked. A page update is not proof that renal instructions changed.

No raw SPL XML, original XML hash or separate Drugs@FDA revision-history review was performed.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e8ef36b-71fa-4492-a16f-577d5f7d111d
Retrieved
2026-09-10
Exact label title
BELEODAQ - belinostat injection, powder, lyophilized, for solution
DailyMed Set ID
2e8ef36b-71fa-4492-a16f-577d5f7d111d
Labeler
Acrotech Biopharma Inc
DailyMed page updated
2025-04-07
Label revision
4/2025
Archive publication date
2025-04-09
SPL version
10
FDA application
NDA206256
Renal-function method
CrCl, mL/min; equation not named in selected renal subsection
Source date/version
4/2025
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
4e80cec9b87a4a1694e10e85c22a4af73dda27eec0f03d65918fc7ed42f21223
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

GlobalRPh RX List - Beleodaq

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · IV belinostat; older RX List renal statement. Compare with the separately presented newer label.

Renal method: CrCl, mL/min.
Source date: 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.
Limited or unstudied renal evidence. Not studied does not mean no adjustment is required.

Locally imported selected source sections; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

This RX List version reports no exposure change with creatinine clearance above 39 mL/min and insufficient data to recommend a dose at CrCl 39 mL/min or lower. This is a limitation of this source version, not a finding that no renal adjustment is needed.

RDM33-rxlist-belinostat-beleodaq-C1 · Source locator: Use in patients with renal impairment.

Source-specific limits

Label-era difference requires comparison with current product labeling. Do not use this older evidence gap to override a newer dose table.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/beleodaq-drug/
Retrieved
2026-09-07
Renal-function method
CrCl, mL/min.
Source date/version
Revision date not established in selected retrieval.
Hash meaning
SHA-256 of the local authored summary only; original HTML/PDF/SPL bytes are not bundled or hashed.
Local summary SHA-256
955f4e95886b14de2e803557968317be13d9f2c508227fbc53f50f9bdb07e8a8
Rxlist

GlobalRPh RX List - BELEODAQ

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · BELEODAQ IV; selected renal sections rechecked in September 2026. Earlier source snapshots remain separately visible.

Renal method: CrCl, mL/min; equation not named in selected renal subsection
Source date: Source revision date not established in selected retrieval.
Retrieved: 2026-09-10

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

The currently retrieved mirror specifies 500 mg/m2 IV over 30 minutes daily on days 1-5 of each 21-day cycle at CrCl 30 to below 60 mL/min. Avoid below 30; no adjustment at 60 to below 90.

This differs from the retained earlier mirror summary that lacked a regimen at CrCl 39 or lower. It now agrees with the selected official renal section. This is reconciliation of the retrieved renal wording, not independent approval of the entire monograph or removal of other dose-modification requirements.

RDM56-rxlist-belinostat-beleodaq-988e629ff0-C1 · Source locator: Recommended Dosage in Renal Impairment; Use in Patients with Renal Impairment

Source-specific limits

Selected sections only. A hosted mirror is not independent confirmation of the underlying label.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/beleodaq-drug/
Retrieved
2026-09-10
Renal-function method
CrCl, mL/min; equation not named in selected renal subsection
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
9b0c5b8c54a49f3669fd5a29858ea62c8c74be612a95c34f15ef95ce3fbabbfe

Provenance and preservation

Additional summaries stored on this page: 2 official-label, 2 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://globalrph.com/rx-list/beleodaq-drug/
Source retrieval
2026-09-07. This is not the source publication or label revision date.
Original source type
rxlist summary
Local text SHA-256
59d5f546dc29baea8f0979395c38dae0a45440dd55471ae87b219b8c6c1bdd01
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.

Read the full coverage report