Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E)
Alembic Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
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)]. Erlotinib tablet 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)]. None. Risk Summary Based on animal data and its mechanism of
Erlotinib tablets 25 mg are round, biconvex, white film-coated tablet debossed with “L55” on one side and plain on other side. Bottle of 30 tablets with child resistant closure, NDC 62332-565-30 Bottle of 90 tablets with child resistant closure, NDC 62332-565-90 Erlotinib tablets 100 mg are round, biconvex, white film-coated tablet debossed with “L630” on one side and plain on other side. Bottle of 30 tablets with child resistant closure, NDC 62332-566-30 Bottle of 90 tablets with child resistant closure, NDC 62332-566-90 Erlotinib tablets 150 mg are round, biconvex, white film-coated tablet debossed with “L631” on one side and plain on other side. Bottle of 30 tablets with child resistant closure, NDC 62332-567-30 Bottle of 90 tablets with child resistant closure, NDC 62332-567-90 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). See USP Controlled Room Temperature.
Abbreviated New Drug Application
ERLOTINIB HYDROCHLORIDE - ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED ALEMBIC PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ERLOTINIB TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ERLOTINIB TABLETS. ERLOTINIB TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE Erlotinib tablets are a kinase inhibitor indicated for: (1) 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: (1) Safety and efficacy of erlotinib tablets has 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) DOSAGE AND ADMINISTRATION NSCLC: 150 mg orally, on an empty stomach, once daily. (2.2) Pancreatic cancer: 100 mg orally, on an empty stomach, once daily. (2.3) DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 100 mg, and 150 mg (3) (3) CONTRAINDICATIONS None. (4) (4) WARNINGS AND PRECAUTIONS Interstitial lung disease (ILD): Occurs in 1.1% of patients. Withhold erlotinib for acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever. Discontinue erlotinib if ILD is diagnosed. (5.1) Renal failure: Monitor renal function and electrolytes, particularly in patients at risk of dehydration. Withhold erlotinib for severe renal toxicity. (5.2) Hepatotoxicity: Occurs with or without hepatic impairment, including hepatic failure and hepatorenal syndrome: Monitor periodic liver test Læs hele dokumentet