Drug Information



Brand Name:Gemzar Trade Name:gemcitabine
FDA Approved For:Therapeutic Indications Non-Small Cell Lung Cancer -Gemzar is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer. Pancreatic Cancer -Gemzar 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. Gemzar is indicated for patients previously treated with 5-FU. Pediatric Use:Gemzar has not been studied in pediatric patients. Safety and effectiveness in pediatric patients have not been established.
Carcinogen:Long-term animal studies to evaluate the carcinogenic potential of Gemzar have not been conducted. Mutagen:Gemcitabine induced forward mutations in vitro in a mouse lymphoma (L5178Y) assay and was clastogenic in an in vivo mouse micronucleus assay. Gemcitabine was negative when tested using the Ames, in vivo sister chromatid exchange, and in vitro chromosomal aberration assays, and did not cause unscheduled DNA synthesis in vitro.
Manufacturer and/or Distributor:Eli Lilly

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