Generic name: afatinib
Dosage form: afatinib tablet, film coated
This dosage information does not include all the information needed to use Gilotrif safely and effectively. See full prescribing information for Gilotrif.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
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)].