erlotinib 100 MG Oral Tablet
1 INDICATIONS AND USAGE Erlotinib tablets are a kinase inhibitor indicated for: The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. ( 1.1 ) First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. ( 1.2 ) Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. ( 1.1 ) Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. ( 1.1 ) 1.1 Non-Small Cell Lung Cancer (NSCLC) Erlotinib tablets are indicated for: The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see Clinical Studies ( 14.1 , 14.3 )] . Limitations of use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies ( 14.1 , 14.2 )]. Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies ( 14.4 )] . 1.2 Pancreatic Cancer Erlotinib tablets in combination with gemcitabine are indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [ see Clinical Studies ( 14.5 ) ].
teva pharmaceuticals usa, inc.
ROUND WHITE Teva 7663
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erlotinib 150 MG Oral Tablet
teva pharmaceuticals usa, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
ERLOTINIB Tablets are available as follows: 25 mg: round, biconvex, unscored, white film-coated tablets, debossed TEVA on one side and E2 on the other side; supplied in bottles of 30 (NDC 0093-7662-56). 100 mg: round, biconvex, unscored, white film-coated tablets, debossed TEVA on one side and 7663 on the other side; supplied in bottles of 30 (NDC 0093-7663-56). 150 mg: round, biconvex, unscored, white film-coated tablets, debossed TEVA on one side and 7664 on the other side; supplied in bottles of 30 (NDC 0093-7664-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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