HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 USAGEGemcitabine Injection is a nucleoside metabolic inhibitor indicated:
DOSAGE AND ADMINISTRATIONGemcitabine Injection is for intravenous use only.
DOSAGE FORMS AND STRENGTHSInjection: 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) CONTRAINDICATIONSPatients with a known hypersensitivity to gemcitabine. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThe 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 POPULATIONSLactation: Advise not to breastfeed. (8.2) See 17 for PATIENT COUNSELING INFORMATION. Revised: 6/2019 |

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