GILOTRIF- afatinib tablet, film coated
Boehringer Ingelheim Pharmaceuticals, Inc.
1  INDICATIONS AND USAGEGILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14)].
Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations [see Clinical Studies (14)].
2  DOSAGE AND ADMINISTRATION2.1 Patient SelectionSelect 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.
2.2 Recommended Dose
The recommended dose of GILOTRIF is 40 mg orally once daily until disease progression or no longer tolerated by the patient. Take GILOTRIF at least 1 hour before or 2 hours after a meal.
Do not take a missed dose within 12 hours of the next dose.
2.3 Dose ModificationWithhold GILOTRIF for any drug-related adverse reactions of:
◦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
*National Cancer Institute Common Terminology Criteria for Adverse Events, v 3.0
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.
Permanently discontinue GILOTRIF for:
◦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
P-gp Inhibitors
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)].
P-gp Inducers
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)].
3  DOSAGE FORMS AND STRENGTHSGILOTRIF is available as:
40 mg tablets: light blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T40” on one side and the Boehringer Ingelheim company symbol on the other side.
30 mg tablets: dark blue, f