Generic name: afatinib 20mg
Dosage form: tablet, film coated
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Patient Selection for EGFR Mutation-Positive Metastatic NSCLC
Select patients for 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 (1.1) and Clinical Studies (14.1)]. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.
The recommended dose of GILOTRIF is 40 mg orally, once daily until disease progression or no longer tolerated by the patient.
Severe Renal Impairment
The recommended dose of GILOTRIF in patients with severe renal impairment (estimated glomerular filtration rate [eGFR*] 15 to 29 mL/min /1.73 m2) is 30 mg orally, once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Dose Modifications for Adverse Reactions
- 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 impairment of Grade 2 or higher [see Warnings and Precautions (5.1)]
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 [see Adverse Reactions (6.1)]
- Severe or intolerable adverse reaction occurring at a dose of 20 mg per day
Dose Modifications for Drug Interactions
Reduce GILOTRIF 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 [see Drug Interactions (7) and Clinical Pharmacology (12.3)].
Increase GILOTRIF 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 [see Drug Interactions (7) and Clinical Pharmacology (12.3)].