afely and effectively. See full prescribing information for GILOTRIF.
GILOTRIF™ (afatinib) tablets, for oral use
Initial U.S. Approval: 2013
INDICATIONS AND USAG
GILOTRIF is a kinase inhibitor 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 (1)
Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations (1)
DOSAGE AND ADMINISTRATION
Recommended dose: 40 mg orally, once daily (2.2)
Instruct patients to take GILOTRIF at least 1 hour before or 2 hours after a meal (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg, 30 mg, and 20 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Diarrhea: Diarrhea may result in dehydration and renal failure. Withhold GILOTRIF for severe and prolonged diarrhea not responsive to anti-diarrheal agents. (2.3, 5.1)
Bullous and Exfoliative Skin Disorders: Severe bullous, blistering, and exfoliating lesions occurred in 0.15% of patients. Discontinue for life-threatening cutaneous reactions. Withhold GILOTRIF for severe and prolonged cutaneous reactions. (2.3, 5.2)
Interstitial lung disease (ILD): Occurs in 1.5% of patients. Withhold GILOTRIF for acute onset or worsening of pulmonary symptoms. Discontinue GILOTRIF if ILD is diagnosed. (2.3, 5.3)
Hepatic toxicity: Fatal hepatic impairment occurs in 0.18% of patients. Monitor with periodic liver testing. Withhold or discontinue GILOTRIF for severe or worsening liver tests. (2.3, 5.4)
Keratitis: Occurs in 0.8% of patients. Withhold GILOTRIF for keratitis eva luation. Withhold or discontinue GILOTRIF for confirmed ulcerative keratitis. (2.3, 5.5)
Embryofetal toxicity: Can cause fetal harm. Advise females of the potential hazard to the fetus and to use highly effective contraception. (5.6)
ADVERSE REACTIONS
Most common adverse reactions (≥20%) are diarrhea, rash/dermatitis acneiform, stomatitis, paronychia, dry skin, decreased appetite, pruritus (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Co-administration of P-gp inhibitors can increase afatinib exposure. Reduce GILOTRIF by 10 mg per day if not tolerated. Co-administration of chronic P-gp inducers orally can decrease afatinib exposure. Increase GILOTRIF by 10 mg per day as tolerated. (2.3, 7)
USE IN SPECIFIC POPULATIONS
Nursing mothers: Discontinue drug or nursing (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 07/2013
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
2.2 Recommended Dose
2.3 Dose Modification
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Diarrhea
5.2 Bullous and Exfoliative Skin Disorders
5.3 Interstitial Lung Disease (ILD)
5.4 Hepatic Toxicity
5.5 Keratitis
5.6 Embryofetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7&ems |
