erlotinib 150 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 is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.5) ] .
Mylan Pharmaceuticals Inc.
ROUND WHITE M E 33
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16 HOW SUPPLIED/STORAGE AND HANDLING Erlotinib Tablets are available containing 27.3 mg, 109.3 mg or 163.9 mg of erlotinib hydrochloride equivalent to 25 mg, 100 mg or 150 mg of erlotinib (as the free base), respectively. The 25 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and E over 31 on the other side. They are available as follows: NDC 0378-7131-93 bottles of 30 tablets NDC 0378-7131-05 bottles of 500 tablets The 100 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and E over 32 on the other side. They are available as follows: NDC 0378-7132-93 bottles of 30 tablets NDC 0378-7132-05 bottles of 500 tablets The 150 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and E over 33 on the other side. They are available as follows: NDC 0378-7133-93 bottles of 30 tablets NDC 0378-7133-05 bottles of 500 tablets 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 using a child-resistant closure.
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