GEFTINAT吉非替尼片剂说明书全文(中英对照翻译)

GEFTINAT吉非替尼片剂说明书全文（中英对照翻译）Hepatic Impairment: The influence of hepatic metastases with elevation Table 1: Demographic and Disease Characteristics INDICATIONS AND USAGE For the use only of a Cancer Specialist or a Hospital or an Institution of serum aspartate aminotransferase (AST/SGOT), alkaline phosphatase, Gefitinib Dose GEFITINAT is indicated as monotherapy for the treatment of patients GEFTINAT* and bilirubin has been evaluated in patients with normal (14 patients), 250 mg/day 500 mg/day with locally advanced or metastatic non-small cell lung cancer after (Gefitinib Tablets IP) moderately elevated (13 patients) and severely elevated (4 patients) Characteristic N=66(%) N=76(%) failure of both platinum-based and docetaxel chemotherapies. levels of one or more of these biochemical parameters. Patients with --------------------------------------------------------------------------- The effectiveness of Gefitinib is based on objective response rates (see Composition moderately and severely elevated biochemical liver abnormalities had Age Group CLINICAL PHARMACOLOGY - Clinical Studies section). There are no Each film coated tablet contains: Gefitinib IP 250 mg gefitinib pharmacokinetics similar to individuals without liver 18-64controlled trials demonstrating a clinical benefit, such as improvement years 43 (65) 43 (57) abnormalities (see PRECAUTIONS section). in disease-related symptoms or increased survival. 64-74 years 19 (29) 30 (39) DESCRIPTION Results from two large, controlled, randomized trials in first- line 75 years and

above 4 (6) 3 (4) GEFTINAT (gefitinib tablets IP) contain 250 mg of gefitinib IP and are Renal Impairment: No clinical studies were conducted with Gefitinib in Sex treatment of non-small cell lung cancer showed no benefit from adding available as reddish brown film-coated tablets engraved with GEFTINAT patients with severely compromised renal function (see PRECAUTIONS Male 38 (58) 41 (54) GEFTINAT to doublet, platinum-based chemotherapy. Therefore, on one side and 250 on another side tor daily oral administration. section). Gefitinib and its metabolites are not significantly excreted via GEFTINAT is not indicated for use in this setting. Female 28 (42) 35(46) Gefitinib is an anilinoquinazoline with the chemical name 4-Quinazolin the kidney(<4%). Race amine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-4-morpholin] CONTRAINDICATIONS White 61 (92) 68(89) propoxy]. It has the molecular formula C22H24C1F4O3,a relative Drug-Drug Interactions: In human liver microsome studies, gefitinib had Black 1 (2) 2 (3) GEFTINAT is contraindicated in patients with severe hypersensitivity to molecular mass of 446.9 and is a white-colored powder. Gefitinib is a no

inhibitory effect on CYPIA2, CYP2C9, and CYP3A4 activities at

Asian/Oriental 1 (2) 2 (3) gefitinib or to any other component of GEFTINAT. free base. concentrations ranging from 2-5000 ng/ mL. At the highest concentration Hispanic 0 (0) 3 (4) studied (5000 ng/mL),

gefitinib inhibited CYP2C19 by 24% and WARNINGS Other 3 (5) 1 (1) CLINICAL PHARMACOLOGY CYP2D6 by 43%. Exposure to metoprolol, a substrate of CYP2D6, was Pulmonary Toxicity Smoking History Mechanism of Action: