GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Niraparib tablets (Zejula)

Zejula

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

Cautions / source differences (1)

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

Choose a source to read (2)

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
Mixed capsule and tablet descriptions on the RX source page

The retrieved RX page combines a capsule description with tablet dosage-form content. The selected renal statement is locally retained, but the mixed page is not used to resolve tablet strength or formulation.

Before applying: Use the exact tablet-label source for product selection, and check current oncology labeling. No capsule-to-tablet equivalence or updated indication is inferred from this extract.

Also check: Mixed capsule and tablet descriptions on the RX source page

Official source

Niraparib tablets (Zejula) - selected U.S. label sections

Product / population
ZEJULA film-coated tablets. This entry does not import an older capsule dosing regimen.
Renal measure
Creatinine clearance in mL/min as reported 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 comments

Mild to moderate impairment, reported as CrCl 30-90 mL/min, did not produce clinically significant pharmacokinetic differences. The effects of severe impairment below 30 and ESRD with hemodialysis are unknown.

Dosing boundary

This PK comment is not a complete starting-dose selection algorithm. Use the current indication-, weight-, platelet- and toxicity-specific instructions for the exact product.

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=b7f675e2-159c-490c-b6f4-3f16d9492b7d

Scope: Local label summary; independent clinical review pending. Not a two-source validated protocol. 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 1 source difference / applicability notes

Official product label

Niraparib tablets (Zejula) - selected U.S. label sections

ZEJULA film-coated tablets. This entry does not import an older capsule dosing regimen.

Renal method: Creatinine clearance in mL/min as reported in PK section
Retrieved: 2026-09-05

GlobalRPh RX List

GlobalRPh RX List - Zejula

No adjustment within stated limits. This does not establish dosing outside the studied renal range or population.

Adult product-specific renal information; not a complete prescribing regimen.

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

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

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.

source format discrepancy

Mixed capsule and tablet descriptions on the RX source page

The retrieved RX page combines a capsule description with tablet dosage-form content. The selected renal statement is locally retained, but the mixed page is not used to resolve tablet strength or formulation.

How to use this: Use the exact tablet-label source for product selection, and check current oncology labeling. No capsule-to-tablet equivalence or updated indication is inferred from this extract.

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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d

Product and population scope

ZEJULA film-coated tablets. This entry does not import an older capsule dosing regimen.

RDM32-niraparib-zejula-tablets-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

Niraparib tablets (Zejula) - selected U.S. label sections

Open original reference

Open / share this exact local source

U.S. product labeling / DailyMed · ZEJULA film-coated tablets. This entry does not import an older capsule dosing regimen.

Renal method: Creatinine clearance in mL/min as reported 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 comments

Mild to moderate impairment, reported as CrCl 30-90 mL/min, did not produce clinically significant pharmacokinetic differences. The effects of severe impairment below 30 and ESRD with hemodialysis are unknown.

RDM32-niraparib-zejula-tablets-1 · Source locator: 12.3, Specific Populations

Dosing boundary

This PK comment is not a complete starting-dose selection algorithm. Use the current indication-, weight-, platelet- and toxicity-specific instructions for the exact product.

RDM32-niraparib-zejula-tablets-2 · Source locator: 2; 12.3

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=b7f675e2-159c-490c-b6f4-3f16d9492b7d
Retrieved
2026-09-05
DailyMed Set ID
b7f675e2-159c-490c-b6f4-3f16d9492b7d
Renal-function method
Creatinine clearance in mL/min as reported 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
1099a50817df0396c46efa95a7e6b20173b555c2ace1e05f132e2879d17c90fd
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

GlobalRPh RX List - Zejula

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · Adult product-specific renal information; not a complete prescribing regimen.

Renal method: Cockcroft-Gault CrCl, mL/min.
Source date: January 2024 on retrieved RX page
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.
No adjustment within stated limits. This does not establish dosing outside the studied renal range or population.

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

Renal dosing, restrictions and evidence limits

No adjustment is necessary at Cockcroft-Gault CrCl 30-89 mL/min. Safety in severe impairment or ESRD on hemodialysis is unknown. This RX page contains mixed capsule-description and tablet-dosing material; only the renal statement is imported. Do not use that mixed page to select formulation or tablet strength. Refer to the separately stored tablet label and current oncology prescribing information.

RDM34-rxlist-zejula-drug-C1 · Source locator: Renal impairment; product-description versus dosage-form sections.

Source-specific limits

Source-format discrepancy: capsule description and tablet dosage forms coexist on the retrieved RX page.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/zejula-drug/
Retrieved
2026-09-07
Renal-function method
Cockcroft-Gault CrCl, mL/min.
Source date/version
January 2024 on retrieved RX page
Hash meaning
SHA-256 of local authored summary only, not original HTML, PDF or SPL bytes.
Local summary SHA-256
267012a2c759321dcebc723b7ede823cb9d5b4233aee13e6d19636fb09549285

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=b7f675e2-159c-490c-b6f4-3f16d9492b7d
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
b6c18b470839c24ebc29fbe795cb30a39f1d3d7fbfe6de3c467f99ff73082865
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