Usual Adult Dose for Non-Small Cell Lung Cancer

40 mg orally once a day until disease progression or intolerance by the patient

Comments:

• Take on an empty stomach at least 1 hour before or 2 hours after a meal.
• Epidermal growth factor receptor (EGFR) mutation status should be established prior to therapy initiation.
• Do not take a missed dose within 12 hours of the next dose.

• EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer: For the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an approved test.
• Previously Treated, Metastatic Squamous NSCLC: For the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

Renal Dose Adjustments

• Mild to moderate renal impairment (CrCl 30 mL/min or greater): No adjustment recommended.
• Severe renal impairment (CrCl 15 to 29 mL/min): 30 mg orally once a day
• End stage renal disease (CrCl less than 15 mL/min) or dialysis: Data not available

Liver Dose Adjustments

• Mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment: No adjustment recommended.
• Severe (Child-Pugh C) hepatic impairment: Closely monitor patient and adjust dose if not tolerated.

Dose Adjustments

Dose Modifications for Adverse Reactions:
WITHHOLD THERAPY FOR:

• National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 or higher.
• Diarrhea Grade 2 or higher persisting for 2 or more consecutive days while taking antidiarrheal medication.
• Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable.
• Renal impairment Grade 2 or higher.

• Life-threatening bullous, blistering, or exfoliative skin lesions
• Confirmed interstitial lung disease (ILD)
• Severe drug-induced hepatic impairment
• Persistent ulcerative keratitis
• Symptomatic left ventricular dysfunction
• Severe or intolerable adverse reaction occurring at a dose of 20 mg per day

• P-gp Inhibitors: Reduce the 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.
• P-gp Inducers: Increase the 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.

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• Swallow tablets whole with water.
• In case of swallowing difficulties, the tablets may be dispersed (not crushed) in approximately 100 mL of noncarbonated water. The dispersion may also be given via a gastric tube.
• Take on an empty stomach.
• Do not take a missed dose within 12 hours of the next dose.

• Store in original container to protect from exposure to moisture and light.

• If P-glycoprotein (P-gp) inhibitors are required, they should be administered simultaneously with or after this drug.
• A well-validated test is recommended when determining EGFR mutation status.
• Limitation of use: The safety and efficacy of this drug have not been established in patients whose tumors have resistant EGFR mutations.

Frequently asked questions

• How long can I take Gilotrif (afatinib) for?
• Is Gilotrif (afatinib) a chemotherapy drug?
• How does Gilotrif (afatinib) work?