Country: United States
Language: English
Source: NLM (National Library of Medicine)
GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R)
Gland Pharma Limited
GEMCITABINE HYDROCHLORIDE
GEMCITABINE 200 mg in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
Gemcitabine for Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. Gemcitabine for Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. Gemcitabine for Injection in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). Gemcitabine for Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine for Injection is indicated for patients previously treated with fluorouracil. Gemcitabine for Injection is contraind
Gemcitabine for Injection, USP is supplied as follows: Gemcitabine for Injection, USP is a sterile white to off-white lyophilized powder. Gemcitabine for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free, Lyophilized. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
GEMCITABINE HYDROCHLORIDE - GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLAND PHARMA LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GEMCITABINE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GEMCITABINE FOR INJECTION. GEMCITABINE FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1996 RECENT MAJOR CHANGES Warnings and Precautions, Hemolytic Uremic Syndrome (5.4) 5/2019 INDICATIONS AND USAGE Gemcitabine for Injection 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) DOSAGE AND ADMINISTRATION Gemcitabine for Injection is for intravenous use only. • Ovarian Cancer: 1000 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.1) • Breast Cancer: 1250 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.2) • Non-Small Cell Lung Cancer: 1000 mg/m over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1250 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.3) • Pancreatic Cancer: 1000 mg/m over 30 minutes once weekly for the first 7 weeks, then one week rest, then once weekly for 3 weeks of each 28-day cycle. (2.4) DOSAGE FORMS AND STRENGTHS Gemcitabine for Injection, USP is a white to off-white lyophilized powder available in sterile single-dose vials containing 200 mg or 1 gram gemcitabine. (3) CONTRAINDICATIONS Patients with a known hypersensitivity to gemcitabine. (4) WARNINGS AND PRECAUTIONS • Schedule-De Read the complete document