Generic name: afatinib
Dosage form: tablet, film coated
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Select patients for the first-line treatment of metastatic NSCLC with GILOTRIF based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor specimens [see Indications and Usage (1) and Clinical Studies (14)]. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.
- NCI CTCAE* Grade 3 or higher
- Diarrhea of Grade 2 or higher persisting for 2 or more consecutive days while taking anti-diarrheal medication [see Warnings and Precautions (5.1)]
- Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable [see Warnings and Precautions (5.2)]
- Renal dysfunction of Grade 2 or higher
Resume treatment when the adverse reaction fully resolves, returns to baseline, or improves to Grade 1. Reinstitute GILOTRIF at a reduced dose, i.e., 10 mg per day less than the dose at which the adverse reaction occurred.
- Life-threatening bullous, blistering, or exfoliative skin lesions [see Warnings and Precautions (5.2)]
- Confirmed interstitial lung disease (ILD) [see Warnings and Precautions (5.3)]
- Severe drug-induced hepatic impairment [see Warnings and Precautions (5.4)]
- Persistent ulcerative keratitis [see Warnings and Precautions (5.5)]
- Symptomatic left ventricular dysfunction
- Severe or intolerable adverse reaction occurring at a dose of 20 mg per day
For patients who require therapy with a P-glycoprotein (P-gp) inhibitor, reduce GILOTRIF daily dose by 10 mg if not tolerated. Resume the previous dose after discontinuation of the P-gp inhibitor as tolerated [see Drug Interactions (7) and Clinical Pharmacology (12.3)].
For patients who require chronic therapy with a P-gp inducer, increase GILOTRIF daily dose by 10 mg as tolerated. Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer [see Drug Interactions (7) and Clinical Pharmacology (12.3)].