gemzar健择吉西他滨fda使用说明书.docVIP

1 ? 1 g/single-use vial (3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Gemzar safely and effectively. See full prescribing information for Gemzar. -------------------------------CONTRAINDICATIONS------------------------------ Patients with a known hypersensitivity to gemcitabine (4) GEMZAR (gemcitabine for injection) Powder, Lyophilized, For Solution For Intravenous Use Initial U.S. Approval: 1996 --------------------------- RECENT MAJOR CHANGES -------------------------- Warnings and Precautions, Capillary Leak Syndrome (5.8) 05/2013 ----------------------------INDICATIONS AND USAGE --------------------------- Gemzar ? is a nucleoside metabolic inhibitor indicated: ? in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum- based therapy (1.1) ? in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated (1.2) ? in combination with cisplatin for the treatment of non-small cell lung cancer (1.3) ? as a single agent for the treatment of pancreatic cancer (1.4) ------------------------WARNINGS AND PRECAUTIONS----------------------- ? Schedule-dependent toxicity: Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly. (5.1) ? Myelosuppression: Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression. (5.2, 5.7) ? Pulmonary Toxicity and Respiratory Failure: Discontinue Gemzar immediately for unexplained new or worsening dyspnea or evidence of severe pulmonary toxicity. (5.3) ? Hemolytic-Uremic Syndrome (HUS): Monitor renal function prior to initiation and during therapy. Discontinue Gemzar for HUS or severe renal impairment. (5.4) ? Hepatic Toxicity: Monitor hepati