GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Afatinib - GILOTRIF tablets

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

GILOTRIF / afatinib

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

Cautions / source differences (1)
Review first - source-specific qualification

Indexed MDRD eGFR and diarrhea management are separate decisions

The starting-dose band uses indexed MDRD eGFR; new diarrhea-related renal injury follows the separate toxicity pathway.

Before applying: Confirm the source measure and reassess toxicity even after selecting the appropriate baseline renal dose.

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 (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.

Official source

DailyMed / GILOTRIF exact product label

Product / population
GILOTRIF tablets for its defined NSCLC indications. Baseline renal dosing and treatment-emergent toxicity modifications are distinct.
Renal measure
MDRD eGFR, mL/min/1.73 m2

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

Start at 30 mg orally once daily for pre-existing severe impairment, defined by MDRD eGFR 15-29 mL/min/1.73 m2. No starting adjustment is needed at 30-89. Patients below 15 or receiving dialysis were not studied.

Take at least one hour before or two hours after food. Grade 2 diarrhea lasting more than 48 hours or Grade 3 or higher diarrhea requires withholding until recovery to Grade 1 or less and resumption at the appropriate reduced dose. Do not treat a baseline renal adjustment as a substitute for toxicity management.

Source revision: 4/2022 | Retrieved: 2026-09-09. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fd638e5e-8032-e7ca-0179-95e96ab5d387

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 1 source difference / applicability notes

Official product label

DailyMed / GILOTRIF exact product label

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

GILOTRIF tablets for its defined NSCLC indications. Baseline renal dosing and treatment-emergent toxicity modifications are distinct.

Renal method: MDRD eGFR, mL/min/1.73 m2
Retrieved: 2026-09-09

Read local renal resultOpen original reference
GlobalRPh RX List

GlobalRPh RX List - GILOTRIF

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

GILOTRIF tablets for its defined NSCLC indications. Baseline renal dosing and treatment-emergent toxicity modifications are distinct.

Renal method: MDRD eGFR, mL/min/1.73 m2
Retrieved: 2026-09-09

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

Indexed MDRD eGFR and diarrhea management are separate decisions

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:

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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 1 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.

renal measure and toxicity

Indexed MDRD eGFR and diarrhea management are separate decisions

The starting-dose band uses indexed MDRD eGFR; new diarrhea-related renal injury follows the separate toxicity pathway.

How to use this: Confirm the source measure and reassess toxicity even after selecting the appropriate baseline renal dose.

GlobalRPh RX List - GILOTRIFDailyMed / GILOTRIF exact product label

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.

Original content / product scopeDailyMed / GILOTRIF exact product labelGlobalRPh RX List - GILOTRIF
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/gilotrif-drug/

Exact product and population

GILOTRIF tablets for its defined NSCLC indications. Baseline renal dosing and treatment-emergent toxicity modifications are distinct.

RDM55-SCOPE-afatinib-gilotrif · Source section: Selected source product scopeRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

DailyMed / GILOTRIF exact product label

Open original reference

Open / share this exact local source

DailyMed / Boehringer Ingelheim Pharmaceuticals, Inc. · GILOTRIF tablets for its defined NSCLC indications. Baseline renal dosing and treatment-emergent toxicity modifications are distinct.

Renal method: MDRD eGFR, mL/min/1.73 m2
Source date: 4/2022
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

Start at 30 mg orally once daily for pre-existing severe impairment, defined by MDRD eGFR 15-29 mL/min/1.73 m2. No starting adjustment is needed at 30-89. Patients below 15 or receiving dialysis were not studied.

Take at least one hour before or two hours after food. Grade 2 diarrhea lasting more than 48 hours or Grade 3 or higher diarrhea requires withholding until recovery to Grade 1 or less and resumption at the appropriate reduced dose. Do not treat a baseline renal adjustment as a substitute for toxicity management.

RDM55-official-afatinib-gilotrif-5b9b5a1628-C1 · Source locator: Sections 2.2-2.4, 5.1, 8.6 and 12.3

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/lookup.cfm?setid=fd638e5e-8032-e7ca-0179-95e96ab5d387
Retrieved
2026-09-09
Exact label title
GILOTRIF - afatinib tablet, film coated
DailyMed Set ID
fd638e5e-8032-e7ca-0179-95e96ab5d387
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
DailyMed page updated
2025-11-13
Label revision
4/2022
Renal-function method
MDRD eGFR, mL/min/1.73 m2
Source date/version
4/2022
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
cdd9b3aa110a413cd1b112cb85aa13924ee15084008f2d2348507db12890769e
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

GlobalRPh RX List - GILOTRIF

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · GILOTRIF tablets for its defined NSCLC indications. Baseline renal dosing and treatment-emergent toxicity modifications are distinct.

Renal method: MDRD eGFR, mL/min/1.73 m2
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

For pre-existing severe impairment, MDRD eGFR 15-29 mL/min/1.73 m2, the recommended starting dose is 30 mg orally once daily. Mild or moderate impairment, eGFR 30-89, requires no starting-dose adjustment. eGFR below 15 and dialysis have not been studied.

Diarrhea can cause dehydration and renal injury. These toxicity precautions are not replaced by selecting a baseline renal dose. The label's interruption and dose-reduction instructions must be applied separately when severe or persistent diarrhea occurs.

RDM55-rxlist-afatinib-gilotrif-e1b8818474-C1 · Source locator: Renal Impairment; selected Dosage, Pharmacokinetics and Warnings sections

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/gilotrif-drug/
Retrieved
2026-09-09
Renal-function method
MDRD eGFR, mL/min/1.73 m2
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
02c7587748b114414857dd5046547b4a84c9c14d659429236e9f5ea63a830b18

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://globalrph.com/rx-list/gilotrif-drug/
Source retrieval
2026-09-09. This is not the source publication or label revision date.
Original source type
rxlist summary
Local text SHA-256
c15503b22901bdf07e241ad990c82bd740ea0e6428ce74b13261797769eb7b65
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