ial response.
Table 4 Objective Tumor Responses in Gilotrif-Treated Patients Based on Investigator Assessment in the “Other” (Uncommon) EGFR Mutation Subgroup
EGFR Mutations Number of Gilotrif-Treated Patients Number of Patients with Partial Responses Duration of Response
L858R and T790M 5 1 6.9 months
L858R and S768I 2 1 12.4+ months
S768I 1 1 16.5+ months
G719X 3 1 9.6 months
16 HOW SUPPLIED/STORAGE AND HANDLING
Gilotrif tablets are available as follows:
40 mg: 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.
Unit of use bottles of 30 NDC: 0597-0138-30
30 mg: dark blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T30” on one side and the Boehringer Ingelheim company symbol on the other side.
Unit of use bottles of 30 NDC: 0597-0137-30
20 mg: white to slightly yellowish, film-coated, round, biconvex, bevel-edged tablets debossed with “T20” on one side and the Boehringer Ingelheim company symbol on the other side.
Unit of use bottles of 30 NDC: 0597-0141-30
Storage
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense medication in the original container to protect from exposure to high humidity and light.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
•Diarrhea
Advise patients that diarrhea occurs in nearly all patients who receive Gilotrif. Inform patients that diarrhea may result in dehydration and renal impairment if not treated. Advise patients to notify their physician if diarrhea develops and to seek medical attention promptly for severe or persistent diarrhea [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
•Bullous and Exfoliative Skin Disorders
Advise patients to minimize sun exposure with protective clothing and use of sunscreen while taking Gilotrif [see Warnings and Precautions (5.2)].
•Interstitial Lung Disease
Advise patients to immediately report any new or worsening lung symptoms, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, fever [see Warnings and Precautions (5.3)].
•Hepatic Toxicity
Advise patients that they will need to undergo liver function monitoring periodically. Advise patients to immediately report any symptoms of a liver problem (e.g., skin or the whites of eyes turn yellow, urine turns dark or brown (tea colored), pain on the right side of stomach, bleed or bruise more easily than normal, lethargy) [see Warnings and |
