erlotinib 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 have not been established in patients with NSCLC whose tumors have other EGFR mutations. ( 1.1 ) Erlotinib is 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 )] .
zydus pharmaceuticals (usa) inc.
ROUND WHITE 915
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16 HOW SUPPLIED/STORAGE AND HANDLING
ERLOTINIB Tablets equivalent to 25 mg of
ERLOTINIB are white to off-white, round, film-coated tablets, debossed with '913' on one side and plain on other side and are supplied as follows: NDC 68382-913-06 in bottles of 30 tablets with child-resistant closure NDC 68382-913-16 in bottles of 90 tablets with child-resistant closure NDC 68382-913-84 in unit-dose blister cartons of 30 tablets (3 x 10 unit-dose)
ERLOTINIB Tablets equivalent to 100 mg of
ERLOTINIB are white to off-white, round, film-coated tablets, debossed with '914' on one side and plain on other side and are supplied as follows: NDC 68382-914-06 in bottles of 30 tablets with child-resistant closure NDC 68382-914-16 in bottles of 90 tablets with child-resistant closure NDC 68382-914-84 in unit-dose blister cartons of 30 tablets (3 x 10 unit-dose)
ERLOTINIB Tablets equivalent to 150 mg of
ERLOTINIB are white to off-white, round, film-coated tablets, debossed with '915' on one side and plain on other side and are supplied as follows: NDC 68382-915-06 in bottles of 30 tablets with child-resistant closure NDC 68382-915-16 in bottles of 90 tablets with child-resistant closure NDC 68382-915-84 in unit-dose blister cartons of 30 tablets (3 x 10 unit-dose) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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