Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E)
Avera McKennan Hospital
ERLOTINIB HYDROCHLORIDE
ERLOTINIB 100 mg
PRESCRIPTION DRUG
New Drug Application
TARCEVA- ERLOTINIB HYDROCHLORIDE TABLET AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TARCEVA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TARCEVA. TARCEVA (ERLOTINIB) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE TARCEVA is a kinase inhibitor indicated for: • • • • Limitations of Use: • • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • • • • • ® 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. (1.1) Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1) Treatment of locally advanced or metastatic NSCLC after failure of 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) TARCEVA is not recommended for use in combination with platinum-based chemotherapy. Safety and efficacy of TARCEVA have not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution. 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) Tablets: 25 mg, 100 mg, and 150 mg. (3) None. (4) Interstitial Lung Disease (ILD): Occurs in 1.1% of patients. Withhold TARCEVA for acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever. Discontinue TARCEVA if ILD is diagnosed. (5.1) Renal Failure: Monitor renal function and electrolytes, particularly in Läs hela dokumentet