Rx Item-Gilotrif 40Mg Tab 30 By Boehringer Healthcare

GILOTRIF- afatinib tablet, film coated
Boehringer Ingelheim Pharmaceuticals, Inc.

1??INDICATIONS AND USAGE

1.1 EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer
GILOTRIF is 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 [see Clinical Studies (14.1)].



Limitation of Use: The safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations [see Clinical Studies (14.1)].

? 1.2 Previously Treated, Metastatic Squamous NSCLC
? GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy [see Clinical Studies (14.2)].

2??DOSAGE AND ADMINISTRATION

2.1 Patient Selection for EGFR Mutation-Positive Metastatic NSCLC
Select patients for first-line treatment of metastatic NSCLC with GILOTRIF based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor specimens [see Indications and Usage (1.1) and Clinical Studies (14.1)]. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: https://www.fda.gov/CompanionDiagnostics.

RX ITEM-Gilotrif 40Mg Tab 30 By Boehring
NDC 00597-0138-30 UPC/GTIN No.3-05970-13830-3 Mfg.Part No.41633 Gilotrif 40mg Tab 30 by Boehringer Healthcare

Gilotrif 40Mg Tab 30 By Boehringer Healt
BRAND: GILOTRIF NDC: 00597-0138-30,597013830 UPC: 3-05970-13830-3,305970138303 Specialty Healthcare-Special Order Gilotrif 40mg Tab 30 by Boehringer Healthcare

AFATINIB DIMALEATE ORAL T
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Gilotrif 40mg Tab 30 by Boehri
Gilotrif 40mg Tab 30 by Boehringer Healthcare