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
INDICATIONS AND USAGE
Gemcitabine is a nucleoside metabolic inhibitor indicated:
DOSAGE AND ADMINISTRATION
Gemcitabine for injection, USP is for intravenous use only.
DOSAGE FORMS AND STRENGTHS
For injection: 2 gram lyophilized powder in single-dose vials for reconstitution. (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 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.
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
gemcitabine injection powder 2GM Highlights
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Contact Medical Information.
Submit a medical question for Pfizer prescription products.
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at