GlobalRPh Renal Dosing Masterv6.6
Source review / handoff

Belinostat (BELEODAQ)

One or two intact local summaries. No averaged regimen, patient-specific dose or automatic source preference.

Selecting here opens the current stored cards. The pinned link below records their fingerprints. Do not enter patient information in links or searches.

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1 local source card selected. Local card fingerprints checked where supplied. This is not an original-document hash, source-currency guarantee or clinical approval. Record-level cautions below are the current library's cautions, not a frozen prior version.

Copy is optional; the link can be selected and copied manually. No patient data or dose decision is collected.

Clinical context remains essential

Independent clinical review is pending. Confirm indication, exact formulation/route, population, renal measure and units, kidney-function stability, dialysis prescription, interacting drugs, monitoring and source revision. An RX mirror and its original label are not independent corroboration. Missing disagreement notes do not certify agreement.

Check source scope before reading a dose

DailyMed / BELEODAQ exact product label

Product / population
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 revision
4/2025
Retrieved
2026-09-10
Local review status
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Documented differences and cautions on this drug

All record notes are retained here, including notes about sources not selected in this review.

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.

What to reconcile: 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.

Open this note and its source references

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.

What to reconcile: 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.

Open this note and its source references
Official

DailyMed / BELEODAQ exact product label

Open original reference

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

Document the clinical decision separately

This reference does not select a regimen. Complete the indication, measured/estimated renal function and trend, dialysis setting, source rationale, monitoring and reassessment plan in your institution's approved documentation system. Confirm the complete current source before adopting its regimen.

GlobalRPh v6.6 | RDM66-DIRECT-PHP-20260911 | Local library date 2026-09-11. Selected-card identity does not imply clinical verification.

Pinned reference: https://globalrph.com/blogCalcs/renal-dosing-master/compare.php?id=belinostat-beleodaq&s1=RDM56-official-belinostat-beleodaq-f1cae1d516&h1=cac98d1285fe9c5f298e0ce851b44ed1085667809fb705356e763570bea72fab