GEMCITABINE- gemcitabine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp.

INN (International Name):

GEMCITABINE HYDROCHLORIDE

Composition:

GEMCITABINE 38 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gemcitabine 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 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 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 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 injection is indicated for patients previously treated with fluorouracil. Gemcitabine Injection is contraindicated in patients with

Product summary:

Gemcitabine injection is available in sterile single-use vials individually packaged in a carton as follows: Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Gemcitabine Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GEMCITABINE- GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GEMCITABINE INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GEMCITABINE
INJECTION.
GEMCITABINE INJECTION,
FOR INTRAVENOUS INFUSION USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Hemolytic Uremic Syndrome (5.4) 6/2019
INDICATIONS AND USAGE
Gemcitabine 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 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
200 mg/5.26 mL injection vial (3)
1 g/26.3 mL injection vial (3)
2 g/52.6 mL injection vial (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 more frequently
than once weekly. (5.1)
Myelosuppression: Monitor fo