GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Talazoparib capsules (Talzenna)

Local official-label summaryBase record retrieved 2026-09-05See the evidence for this drug5 sources available - open source summaries, references and comparisons

Talzenna

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

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

The moderate-renal mCRPC dose disagreement is still present

The current official label states 0.35 mg daily with enzalutamide at CrCl 30-59; the retrieved RX mirror still states 0.5 mg daily for that setting. Breast-cancer monotherapy is a separate regimen.

Before applying: Keep the conflict flagged and prioritize the exact official product label; do not average the doses or transfer the monotherapy schedule.

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 (5)

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
Dose disagreement: moderate-renal mCRPC instruction

The RX mirror and exact official label differ for moderate-renal mCRPC dosing with enzalutamide. The disputed mirror extract is documentation, not permission.

Before applying: Read the newly dated official section and have oncology/pharmacy adjudicate the discrepancy. Do not average doses or confuse breast-cancer and mCRPC regimens.

Also check: Dose disagreement: moderate-renal mCRPC instruction

Official source

TALZENNA - talazoparib capsules

Product / population
TALZENNA: distinguish breast-cancer monotherapy from HRR-mutated mCRPC with enzalutamide.
Renal measure
CrCl, mL/min

Selected sections only; not a complete prescribing monograph or independent clinician approval.

Exact DailyMed HTML identity and named sections checked. Raw SPL XML, original document hash and complete revision history were not obtained.

Renal dosing, restrictions and evidence limits

For mCRPC with enzalutamide, CrCl 30-59 mL/min requires 0.35 mg once daily; CrCl 15-29 requires 0.25 mg once daily. Breast-cancer monotherapy uses 0.75 mg daily at 30-59 and 0.5 mg daily at 15-29. These are separate indication-specific renal regimens.

Hemodialysis has not been studied. Review hematologic toxicity and interacting drugs separately. This dated official renal paragraph does not resolve the mirror's different moderate-renal mCRPC amount by averaging; the mirror remains flagged.

Source revision: 6/2025 | Retrieved: 2026-09-10. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f2423edd-6d24-495c-aec1-c2f457f08d9a

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

Talazoparib capsules (Talzenna) - selected U.S. label sections

Adult TALZENNA capsules. Breast-cancer monotherapy and prostate cancer with enzalutamide remain separate.

Renal method: Creatinine clearance in mL/min; indication-specific renal doses
Retrieved: 2026-09-05

Read local renal resultOpen original reference
Official product label

DailyMed / TALZENNA exact-label renal recheck

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

TALZENNA capsules: separate gBRCAm HER2-negative advanced/metastatic breast-cancer dosing and HRR gene-mutated mCRPC dosing with enzalutamide.

Renal method: CrCl, mL/min; indication-specific schedules
Retrieved: 2026-09-09

Read local renal resultOpen original reference
Official product label

TALZENNA - talazoparib capsules

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

TALZENNA: distinguish breast-cancer monotherapy from HRR-mutated mCRPC with enzalutamide.

Renal method: CrCl, mL/min
Retrieved: 2026-09-10

Read local renal resultOpen original reference
GlobalRPh RX List

GlobalRPh RX List - TALZENNA

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

TALZENNA capsules: separate gBRCAm HER2-negative advanced/metastatic breast-cancer dosing and HRR gene-mutated mCRPC dosing with enzalutamide.

Renal method: CrCl, mL/min; indication-specific schedules
Retrieved: 2026-09-09

Read local renal resultOpen original reference
GlobalRPh RX List

GlobalRPh RX List - TALZENNA

Historical product / current restriction. Historical renal instructions do not establish current prescribing eligibility. Read the regulatory caution.

TALZENNA: distinguish breast-cancer monotherapy from HRR-mutated mCRPC with enzalutamide.

Renal method: CrCl, mL/min; indication and partner drug required
Retrieved: 2026-09-10

Read local renal resultOpen original reference

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

Dose disagreement: moderate-renal mCRPC instructionThe moderate-renal mCRPC dose disagreement is still present

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
Jump to renal guidanceRead 2 difference / caution notesClinician guide

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.

numeric source conflict

Dose disagreement: moderate-renal mCRPC instruction

The RX mirror and exact official label differ for moderate-renal mCRPC dosing with enzalutamide. The disputed mirror extract is documentation, not permission.

How to use this: Read the newly dated official section and have oncology/pharmacy adjudicate the discrepancy. Do not average doses or confuse breast-cancer and mCRPC regimens.

GlobalRPh RX List - TALZENNADailyMed / TALZENNA exact-label renal recheck

Source-specific interpretation; independent clinician adjudication pending.

reconfirmed material dose conflict

The moderate-renal mCRPC dose disagreement is still present

The current official label states 0.35 mg daily with enzalutamide at CrCl 30-59; the retrieved RX mirror still states 0.5 mg daily for that setting. Breast-cancer monotherapy is a separate regimen.

How to use this: Keep the conflict flagged and prioritize the exact official product label; do not average the doses or transfer the monotherapy schedule.

GlobalRPh RX List - TALZENNATALZENNA - talazoparib capsules

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.
Official source

Talazoparib capsules (Talzenna) - selected U.S. label sections

Adult TALZENNA capsules. Breast-cancer monotherapy and prostate cancer with enzalutamide remain separate.

Method: Creatinine clearance in mL/min; indication-specific renal doses

Renal dose by indicationRead this complete source summary

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.

Original content / product scopeTalazoparib capsules (Talzenna) - selected U.S. label sectionsDailyMed / TALZENNA exact-label renal recheckTALZENNA - talazoparib capsulesGlobalRPh RX List - TALZENNAGlobalRPh RX List - TALZENNA
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=f2423edd-6d24-495c-aec1-c2f457f08d9a

Product and population scope

Adult TALZENNA capsules. Breast-cancer monotherapy and prostate cancer with enzalutamide remain separate.

RDM32-talazoparib-talzenna-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

Talazoparib capsules (Talzenna) - selected U.S. label sections

Open original reference

Open / share this exact local source

U.S. product labeling / DailyMed · Adult TALZENNA capsules. Breast-cancer monotherapy and prostate cancer with enzalutamide remain separate.

Renal method: Creatinine clearance in mL/min; indication-specific renal doses
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 dose by indication

CrClLabeled breast-cancer indicationHRR-mutated mCRPC with enzalutamide
30-59 mL/min0.75 mg once daily0.35 mg once daily
15-29 mL/min0.5 mg once daily0.25 mg once daily

Do not substitute the breast-cancer dose for the enzalutamide combination dose.

RDM32-talazoparib-talzenna-1 · Source locator: 2.6

Limit

This summary does not assign a dialysis regimen or replace the drug-interaction and marrow-toxicity dose modifications.

RDM32-talazoparib-talzenna-2 · Source locator: 2; 8.7

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=f2423edd-6d24-495c-aec1-c2f457f08d9a
Retrieved
2026-09-05
DailyMed Set ID
f2423edd-6d24-495c-aec1-c2f457f08d9a
Renal-function method
Creatinine clearance in mL/min; indication-specific renal doses
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
e6c30e14b17fcb30df92268e001ab5ca49479823872b6b07aba8b27ccf7affca
Official

DailyMed / TALZENNA exact-label renal recheck

Open original reference

Open / share this exact local source

DailyMed / Pfizer Laboratories Div Pfizer Inc. · TALZENNA capsules: separate gBRCAm HER2-negative advanced/metastatic breast-cancer dosing and HRR gene-mutated mCRPC dosing with enzalutamide.

Renal method: CrCl, mL/min; indication-specific schedules
Source date: 6/2025
Retrieved: 2026-09-09

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 2.6: for gBRCAm HER2-negative advanced/metastatic breast cancer, CrCl 30-59 mL/min uses 0.75 mg orally once daily; CrCl 15-29 uses 0.5 mg once daily. For HRR gene-mutated mCRPC with enzalutamide, the corresponding doses are 0.35 mg and 0.25 mg once daily.

The moderate-renal mCRPC instruction differs from the selected RX mirror. This exact product-label recheck is separately attributed; it does not revise earlier stored source text, establish a hemodialysis regimen or constitute independent clinical approval.

RDM54-official-talazoparib-talzenna-6020d48257-C1 · Source locator: Section 2.6; table of contents and label identity/revision

Source-specific limits

Selected sections only. Source mirror and underlying label are not independent confirmations.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f2423edd-6d24-495c-aec1-c2f457f08d9a
Retrieved
2026-09-09
Exact label title
TALZENNA - talazoparib capsule
DailyMed Set ID
f2423edd-6d24-495c-aec1-c2f457f08d9a
Labeler
Pfizer Laboratories Div Pfizer Inc.
DailyMed page updated
2025-12-18
Label revision
6/2025
Renal-function method
CrCl, mL/min; indication-specific schedules
Source date/version
6/2025
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
a5bc81aba0ceab3038586c7c852c010f1b648e2d5f15856ad40ce4b694cab32a
Official

TALZENNA - talazoparib capsules

Open original reference

Open / share this exact local source

DailyMed / Pfizer Inc. · TALZENNA: distinguish breast-cancer monotherapy from HRR-mutated mCRPC with enzalutamide.

Renal method: CrCl, mL/min
Source date: 6/2025
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

For mCRPC with enzalutamide, CrCl 30-59 mL/min requires 0.35 mg once daily; CrCl 15-29 requires 0.25 mg once daily. Breast-cancer monotherapy uses 0.75 mg daily at 30-59 and 0.5 mg daily at 15-29. These are separate indication-specific renal regimens.

Hemodialysis has not been studied. Review hematologic toxicity and interacting drugs separately. This dated official renal paragraph does not resolve the mirror's different moderate-renal mCRPC amount by averaging; the mirror remains flagged.

RDM57-official-talazoparib-talzenna-6020d48257-C1 · Source locator: Sections 2.6 and 8.7

Source-specific limits

Selected sections only; not a complete prescribing monograph or independent clinician approval.

Exact DailyMed HTML identity and named sections checked. Raw SPL XML, original document hash and complete revision history were not obtained.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f2423edd-6d24-495c-aec1-c2f457f08d9a
Retrieved
2026-09-10
Exact label title
TALZENNA - talazoparib capsules
DailyMed Set ID
f2423edd-6d24-495c-aec1-c2f457f08d9a
Labeler
Pfizer Inc.
Label revision
6/2025
Renal-function method
CrCl, mL/min
Source date/version
6/2025
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
adf5cac0e9143ccaaf540fc95ef8bad564a4b76210b3cfa36d02cac6349f68ba
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

GlobalRPh RX List - TALZENNA

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · TALZENNA capsules: separate gBRCAm HER2-negative advanced/metastatic breast-cancer dosing and HRR gene-mutated mCRPC dosing with enzalutamide.

Renal method: CrCl, mL/min; indication-specific schedules
Source date: Source revision date not established in selected retrieval.
Retrieved: 2026-09-09

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

SOURCE DISAGREEMENT - NOT PRESCRIBING PERMISSION. The RX mirror prints 0.5 mg once daily with enzalutamide for mCRPC at CrCl 30-59 mL/min. The separately retrieved official label prints 0.35 mg for this same setting. This disputed mirror instruction is held for reconciliation.

The mirror's breast-cancer bands are 0.75 mg daily at CrCl 30-59 and 0.5 mg daily at 15-29. Its severe-renal mCRPC amount is 0.25 mg daily. Keep indication and companion drug attached; do not choose a dose by averaging sources.

RDM54-rxlist-talazoparib-talzenna-6a9ab05865-C1 · Source locator: Dosage and Administration; Renal Impairment; selected Warnings and Precautions

Source-specific limits

Selected sections only. Source mirror and underlying label are not independent confirmations.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/talzenna-drug/
Retrieved
2026-09-09
Renal-function method
CrCl, mL/min; indication-specific schedules
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
6af24c87919506e2f2351b1562ae09e7baabc0078523146d0a38a8cd4a4a137c
Rxlist

GlobalRPh RX List - TALZENNA

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · TALZENNA: distinguish breast-cancer monotherapy from HRR-mutated mCRPC with enzalutamide.

Renal method: CrCl, mL/min; indication and partner drug required
Source date: 2/2024 (printed mirror revision)
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.
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 retrieved February 2024 mirror still prints 0.5 mg once daily with enzalutamide for mCRPC at CrCl 30-59 mL/min. The separately retrieved June 2025 official label specifies 0.35 mg once daily for that same population. The disagreement persists on this recheck.

Do not use the mirror's moderate-renal mCRPC amount as the current product-label recommendation. Preserve it as a flagged source observation, not as an alternative regimen endorsed by this tool.

RDM57-rxlist-talazoparib-talzenna-6a9ab05865-C1 · Source locator: Recommended Dosage in Patients with Renal Impairment: HRR Gene-Mutated mCRPC

Source-specific limits

Selected sections only; not a complete prescribing monograph or independent clinician approval.

The hosted label mirror is not independent corroboration of its underlying label. Official-label confirmation of this new card remains pending unless a separate official card is shown.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/talzenna-drug/
Retrieved
2026-09-10
Renal-function method
CrCl, mL/min; indication and partner drug required
Source date/version
2/2024 (printed mirror revision)
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
d5bcb4c0145a298f04000a973189ae1ead3f3ae47d7c5e55ef8d1801eab7ae96

Provenance and preservation

Additional summaries stored on this page: 3 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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f2423edd-6d24-495c-aec1-c2f457f08d9a
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
af863135065fbd6a12259e8b29641dfb1595461252bcebb57dc1a61b47bd7ddc
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