Adult Dosing
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
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Diarrhea resulting in dehydration with or without renal impairment has occured in patients treated with afatinib
- In patients who develop prolonged Grade 2 diarrhea lasting more than 48 hours or greater than or equal to Grade 3 diarrhea, withhold therapy until diarrhea resolves to Grade 1 or less, and resume therapy with appropriate dose reduction
- Administer an anti-diarrheal agent (e.g., loperamide) for self-administration at the onset of diarrhea and instruct patients to continue anti-diarrheal therapy until loose bowel movements cease for 12 hours
- Grade 3 cutaneous reactions characterized by bullous, blistering, and exfoliating lesions have occurred in patients who received therapy. Discontinue therapy in patients who develop life-threatening bullous, blistering, or exfoliating lesions. For patients who develop prolonged Grade 2 cutaneous adverse reactions lasting more than 7 days, intolerable Grade 2, or Grade 3 cutaneous reactions, withhold therapy until the adverse reaction resolves to Grade 1 or less, and resume with appropriate dose reduction
- Interstitial lung disease (ILD) presented as lung infiltration, pneumonitis, acute respiratory distress syndrome, or alveolitis allergic have been reported with afatinib therapy. Interrupt the therapy if there is an acute onset or worsening of pulmonary symptoms and discontinue the treatment once ILD is confirmed and provide appropriate therapy
- Obtain periodic liver testing in patients during therapy. Withhold therapy in patients who develop worsening of liver function. In patients who develop severe hepatic impairment therapy should be discontinued
- Keratitis, characterized as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye may occur. Discontinue therapy on confirmed ulcerative keratitis.
- Afatinib causes fetal harm when administered to a pregnant woman, women of childbearing potential should be advised to avoid becoming pregnant by using highly effective contraception and if become pregnant while on therapy, she should be apprised of the potential hazard to the fetus or potential risk for loss of the pregnancy
Supplemental Patient Information
- Instruct patients to take GILOTRIF at least 1 hour before or 2 hours after a meal
Pregnancy Category:D
Breastfeeding: Safety unknown; as per manufacturer's data high levels of afatinib and its metabolites are excreted in rat milk. It is unknown whether excreted in human milk, as many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should be advised against breast-feeding while receiving therapy.
