Gilotrif Dosage

Patient Selection for Non-Resistant EGFR Mutation-Positive Metastatic NSCLC

Select patients for first-line treatment of metastatic NSCLC with GILOTRIF based on the presence of non-resistant EGFR mutations in tumor specimens. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage

The recommended dosage 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.

Dosage Modifications for Adverse Reactions

Withhold GILOTRIF for:

• Grade* 3 or higher adverse reactions
• Diarrhea of Grade 2 persisting for 2 or more consecutive days while taking anti-diarrheal medication
• Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable

* National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), 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 exfoliating skin lesions
• Confirmed interstitial lung disease (ILD)
• Severe drug-induced hepatic impairment
• Gastrointestinal perforation
• Persistent ulcerative keratitis
• Symptomatic left ventricular dysfunction
• Severe or intolerable adverse reaction occurring at a dose of 20 mg per day

Dosage Modification for Pre-Existing Severe Renal Impairment

The recommended dosage of GILOTRIF in patients with pre-existing severe renal impairment (estimated glomerular filtration rate [eGFR*] 15 to 29 mL/min /1.73 m2) is 30 mg orally once daily.

* Use the Modification of Diet in Renal Disease [MDRD] formula to estimate eGFR.

Dosage Modifications for Drug Interactions