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Select patients for first-line treatment of metastatic NSCLC with Afatinib based on the presence of non-resistant EGFR mutations in tumor specimens.
The recommended dosage of Afatinib is 40 mg orally once daily until disease progression or no longer tolerated by the patient.
Take Afatinib at least 1 hour before or 2 hours after a meal.
Do not take a missed dose within 12 hours of the next dose.
Withhold Afatinib for:
Grade* 3 or higher adverse reactions
Diarrhea of Grade 2 persisting for 2 or more consecutive days while taking anti-diarrheal medication.
Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable
*National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v 3.0
Resume treatment when the adverse reaction fully resolves, returns to baseline, or improves to Grade 1.
Reinstitute Afatinib at a reduced dose, i.e., 10 mg per day less than the dose at which the adverse reaction occurred.
Permanently discontinue Afatinib for:
Life-threatening bullous, blistering, or exfoliating skin lesions.
Confirmed interstitial lung disease (ILD).
Severe drug-induced hepatic impairment.
Gastrointestinal perforation.
Persistent ulcerative keratitis.
Symptomatic left ventricular dysfunction.
Severe or intolerable adverse reaction occurring at a dose of 20 mg per day.
The recommended dosage of Afatinib in patients with pre-existing severe renal impairment (estimated glomerular filtration rate [eGFR* ]15 to 29 mL/min /1.73 m2 ) is 30 mg orally once daily.
* Use the Modification of Diet in Renal Disease [MDRD] formula to estimate eGFR.
Reduce Afatinib daily dose by 10 mg if not tolerated for patients who require therapy with a P-glycoprotein (P-gp) inhibitor. Resume the previous dose after discontinuation of the P-gp inhibitor as tolerated.
Increase Afatinib daily dose by 10 mg as tolerated for patients who require chronic therapy with a P-gp inducer. Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer.
from FDA，2022.04
