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 use
Initial U.S. Approval: 1996
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Gemcitabine Injection is a nucleoside metabolic inhibitor indicated:
DOSAGE AND ADMINISTRATION
Gemcitabine Injection is for intravenous use only.
DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/5.26 mL (38 mg/mL), 1 g/26.3 mL (38 mg/mL), or 2 g/52.6 mL (38 mg/mL) in a single-dose vial. (3)
Patients with a known hypersensitivity to gemcitabine. (4)
WARNINGS AND PRECAUTIONS
The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or [email protected], or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
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