GEMCITABINE HYDROCHLORIDE injection powder lyophilized for solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Watson Laboratories, Inc.

Designació comuna internacional (DCI):

GEMCITABINE HYDROCHLORIDE

Composición:

GEMCITABINE 200 mg in 5 mL

tipo de receta:

PRESCRIPTION DRUG

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

GEMCITABINE HYDROCHLORIDE- GEMCITABINE HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
WATSON LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GEMCITABINE FOR INJECTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GEMCITABINE FOR
INJECTION, USP.
GEMCITABINE FOR INJECTION, USP, POWDER, LYOPHILIZED, FOR SOLUTION FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Gemcitabine for injection is a nucleoside metabolic inhibitor
indicated for:
Ovarian cancer in combination with carboplatin (1.1)
Breast cancer in combination with paclitaxel (1.2)
Non-small cell lung cancer in combination with cisplatin (1.3)
Pancreatic cancer as a single-agent (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: 4-week schedule, 1000 mg/m over 30 minutes
on Days 1, 8, and 15 of each 28-day cycle:
3-week schedule; 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 up to 7
weeks (or until toxicity necessitates reducing
or holding a dose), followed by a week of rest from treatment.
Subsequent cycles should consist of infusions once
weekly for 3 consecutive weeks out of every 4 weeks (2.4)
Dose reductions or discontinuation may be needed based on toxicities
(2.1 to 2.4)
DOSAGE FORMS AND STRENGTHS
200 mg vial for injection (3)
1 g vial for injection (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to gemcitabine (4)
WARNINGS AND PRECAUTIONS
Infusion time and dose frequency: Increased toxicity with infusion
time >60 minutes or dosing more frequently than
once weekly. (5.1)
Hematology: Monitor for myelosuppression, which can be dose-limiting.
(5.2, 5.7)
Pulmonary toxicity: Discontinue gemcitabine