Gemcitabine
- Atc Codes:L01BC05
- CAS Codes:122111-03-9
- PHARMGKB ID:122111-03-9
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Toxicological Effects
- Caution and personalized dose adjustment in patients with the following genotypes
- Other genes that may be involved
- Drug Interactions
- Nutrition/Nutraceutical Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Cytogembin, Ebegemcit, Gemcapyr, Gemcitabin, Gemcitara, Gemzar, Tabinell; Belgium: Gemzar; Bulgaria: Gemcitabine, Gemzar; Cyprus: Gemcitabine, Gemzar; Czech Republic: Citegin, Gemcirena, Gemcitabin, Gemcitabine, Gemstad, Gemzar, Naruyd; Denmark: Gemzar; Estonia: Gemcitabine, Gemzar, Nallian; Finland: Gemcitabin, Gemzar; France: Gemcitabine, Gemzar; Germany: Axigem, Citagem, Gembaris, Gemci, Gemcinovine, Gemcit, Gemcitabin, Gemcitabine, Gemcitan, Gemcitelb, Gemedac, Gemzar, Ribozar; Greece: Demozar, Gemcipen, Gemcit, Gemcitabine, Santabin, Tamcibin, Tkemzap; Hungary: Dercin, Gemcitabin, Gemcitabine, Gemstad, Gemzar, Nallian; Ireland: Gemabin, Gemcitabine, Gemzar; Italy: Gemcitabina, Gemzar, Jemta; Latvia: Gemcistad, Gemcit, Gemcitabin, Gemcitabine, Gemzar, Nallian; Lithuania: Gemcit, Gemcitabin, Gemcitabine, Gemzar, Nallian; Luxembourg: Gemzar; Malta: Gemcitabin, Gemzar; Netherlands: Gembaris, Gemcirena, Gemcitabine, Gemzar, Jemta; Poland: Dercin, Gemcitabin, Gemcitabine, Gemstad, Gemzar, Gitrabin, Nallian; Portugal: Gemcit, Gemcitabina, Gemzar; Romania: Daplax, Dercin, Gemcirena, Gemcitabin, Gemcitabina, Gemcitabine, Gemtex, Gemzar, Gitrabin, Nallian; Slovakia: Acytabin, Citegin, Gemcirena, Gemcitabin, Gemcitabine, Gemzar, Naruyd; Slovenia: Gemcitabin, Gemzar; Spain: Gemcitabina, Gemzar; Sweden: Gemcitabin, Gemcitabine, Gemzar; UK: Gemcitabine, Gemzar.
North America
Canada: Gemcitabine, Gemzar; USA: Gemcitabine, Gemzar.
Latin America
Argentina: Abine, Antoril, Eriogem, Gemcitabina, Gemofas, Gemtro, Gezt, Gramagen, Nabigem; Brazil: Gemzar; Mexico: Gemzar.
Asia
Japan: Gemzar.
Drug combinations
Chemistry
Gemcitabine Hydrochloride: C~9~H~11~F~2~N~3~O~4~ HCl. Mw: 299.66. (1) Cytidine, 2′-deoxy-2′,2′-difluoro-, monohydrochloride; (2) 2′-Deoxy-2′,2′-difluorocytidine monohydrochloride (β-isomer). CAS-122111-03-9 (1990).
Pharmacologic Category
Antineoplastic Agents; Antimetabolites; Pyrimidine Analog. (ATC-Code: L01BC05).
Mechanism of action
A pyrimidine antimetabolite which inhibits DNA synthesis by inhibition of DNA polymerase and ribonucleotide reductase, specific for S-phase of the cycle. Gemcitabine diphosphate inhibits DNA synthesis by inhibiting ribonucleotide reductase. Gemcitabine triphosphate incorporates into DNA and inhibits DNA polymerase.
Therapeutic use
Treatment of metastatic breast cancer. Locally-advanced or metastatic non-small cell lung cancer or pancreatic cancer. Advanced, relapsed ovarian cancer.
Pregnancy and lactiation implications
Embryotoxicity and fetal malformations (cleft palate, incomplete ossification, fused pulmonary artery, absence of gallbladder) reported in animal studies. There are no adequate, well-controlled studies in pregnant women. Not recommended during lactation.
Unlabeled use
Treatment of bladder cancer, acute leukemia.
Contraindications
Hypersensitivity to gemcitabine or any component of the formulation. Pregnancy.
Warnings and precautions
Hazardous agent. May cause bone marrow suppression (leukopenia, thrombocytopenia, and anemia). Might cause fever. Hemolytic uremic syndrome reported. Serious hepatotoxicity reported (use caution with hepatic impairment or in hepatic metastases). Pulmonary toxicity occurred. Use with caution in pre-existing renal impairment. Use with caution in the elderly (clearance is affected by age). Use with caution with concurrent radiation therapy (radiation toxicity reported with concurrent and nonconcurrent administration). Increased toxicity with prolongation of infusion time >60 minutes and more frequent than weekly dosing.