GEMCITABINE HYDROCHLORIDE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R)

Available from:

Actavis Pharma, Inc.

INN (International Name):

GEMCITABINE HYDROCHLORIDE

Composition:

GEMCITABINE 200 mg in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindi

Product summary:

Gemcitabine for Injection, USP is a white to off-white lyophilized powder and is supplied as follows: Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Unopened vials of Gemcitabine for Injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature] [see Dosage and Administration (2.5 and 2.6)] .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GEMCITABINE HYDROCHLORIDE- GEMCITABINE HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
ACTAVIS PHARMA, INC.
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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
For injection: 200 mg, 1 gram, or 2 gram lyophilized powder in
single-dose vials for reconstitution. (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to gemcitabine. (4)
WARNINGS AND PRECAUTIONS
Schedule-Dependent Toxicity: Increased toxicity with infusion time
greater than 60 minutes or dosing