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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.
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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 method
MDRD eGFR, mL/min/1.73 m2
Source revision
4/2022
Retrieved
2026-09-09
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.
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.
What to reconcile: Confirm the source measure and reassess toxicity even after selecting the appropriate baseline renal dose.
DailyMed / Boehringer Ingelheim Pharmaceuticals, Inc. · GILOTRIF tablets for its defined NSCLC indications. Baseline renal dosing and treatment-emergent toxicity modifications are distinct.
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.
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.