Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
Erlotinib Hydrochloride (UNII: DA87705X9K) (Erlotinib - UNII:J4T82NDH7E)
Breckenridge Pharmaceutical, 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 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)] . None. Risk Summary Based on animal data and its mechanis
25 mg Tablets: Round, biconvex, white film-coated tablets debossed with "N 25" on one side and plain on the other side; supplied in: Bottles of 30: NDC 51991-890-33 100 mg Tablets: Round, biconvex, white film-coated tablets debossed with "N 100" on one side and plain on the other side; supplied in: Bottles of 30: NDC 51991-891-33 150 mg Tablets: Round, biconvex, white film-coated tablets debossed with "N 150" on one side and plain on the other side; supplied in: Bottles of 30: NDC 51991-892-33 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
Abbreviated New Drug Application
ERLOTINIB- ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED BRECKENRIDGE PHARMACEUTICAL, 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 RECENT MAJOR CHANGES Indications and Usage, Non-Small Cell Lung Cancer (NSCLC) (1.1) 10/2016 Dosage and Administration (2.1) 06/2016 Dosage and Administration, Dose Modifications (2.4) 05/2016 Warnings and Precautions, Cerebrovascular Accident (5.6) 10/2016 Warnings and Precautions, Embryo-fetal Toxicity (5.10) 10/2016 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) 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) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Interstitial lung disease (ILD): Occurs in 1.1% of patients. Withhold erlotinib tablets for acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever. Discontinue erlotinib tablets if ILD is di Perskaitykite visą dokumentą