Gemcitabine (Gemzar)

==General information==
Class/mechanism: Pyrimidine analog; metabolized within cells to the active nucleoside forms: diphosphate (dFdCDP) and triphosphate (dFdCTP). Gemcitabine diphosphate inhibits ribonucleotide reductase, which catalyzes reactions that produce deoxynucleoside triphosphates for DNA synthesis. This inhibition of deoxynucleoside triphosphates helps gemcitabine triphosphate to compete with deoxycytidine triphosphate (dCTP) to be incorporated into DNA. DNA synthesis is halted, since only one additional nucleotide can be added to a DNA strand after gemcitabine is incorporated.Gemcitabine (Gemzar) package insertGemcitabine (Gemzar) package insert (locally hosted backup)
Route: IV
Extravasation: irritant or neutral, depending on reference
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information. 
==Diseases for which it is established (work in progress)==
*Breast cancer
*Non-small cell lung cancer
**Non-small cell lung cancer, nonsquamous
**Non-small cell lung cancer, squamous
*Ovarian cancer
*Pancreatic cancer
*Peripheral T-cell lymphoma
*Urothelial carcinoma
==Diseases for which it is used==
*Carcinoma of unknown primary
*Anaplastic large cell lymphoma
*Bladder cancer
*Cervical cancer
*Cholangiocarcinoma
*Diffuse large B-cell lymphoma
*Esophageal cancer
*Ewing sarcoma
*Extranodal NK- and T-cell lymphoma, nasal type
*Gallbladder cancer
*Hepatocellular carcinoma
*Classical Hodgkin lymphoma
*Leiomyosarcoma
*Malignant pleural mesothelioma
*Mantle cell lymphoma
*Nasopharyngeal carcinoma
*NK- and T-cell lymphoma
*Osteosarcoma
*Primary mediastinal B-cell lymphoma
*Renal cell carcinoma
**Sarcomatoid renal cell carcinoma
*Small cell lung cancer
*Soft tissue sarcoma
*Testicular cancer
*Thymoma
*Transformed lymphoma
*Upper tract urothelial carcinoma
==Patient drug information==
*Gemcitabine (Gemzar) package insert
*Gemcitabine (Gemzar) patient drug information (Chemocare)Gemcitabine (Gemzar) patient drug information (Chemocare)
*Gemcitabine (Gemzar) patient drug information (UpToDate)Gemcitabine (Gemzar) patient drug information (UpToDate)
==History of changes in FDA indication==
===Breast cancer===
* 2004-05-19: New FDA indication in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (Based on Albain et al. 2008)
===Non-small cell lung cancer===
* 1998-08-25: 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. (Based on Cardenal et al. 1999 & Sandler et al. 2000)
===Ovarian cancer===
* 2006-07-14: FDA approved in combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy. (Based on AGO-OVAR 2.5)
* 2010-03-19: New FDA indication for ovarian cancer in combination with carboplatin. (Prior exposure requirement removed; no supporting studies are cited)
* 2013-05-07: FDA indication revised: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (Prior exposure requirement restored; no supporting studies are cited)
===Pancreatic cancer===
* 1996-05-15: Initial FDA approval for first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. (Based on Burris et al. 1997)
* 1996-05-15: Initial FDA approval for patients with adenocarcinoma of the pancreas previously treated with 5-FU. (Based on Rothenberg et al. 1996a)
==History of changes in EMA indication==
The approval of this drug pre-dates the EMA.
*1995-12-01: EURD
==History of changes in PMDA indication==
*2006-06-15: New additional indication for biliary tract cancer.
*2008-11-25: New additional indication for the treatment of urothelial carcinoma.
*2010-02-05: New additional indication and a new dosage for the treatment of inoperable or recurrent breast cancer.
*2011-02-23: New additional indication and a new dosage for the treatment of ovarian cancer which has progressed after cancer chemotherapy.
*2013-02-21: New additional indication and a new dosage for the treatment of relapsed or refractory malignant lymphoma.
==Also known as==
*Code name: LY-188011
*Generic name: difluorodeoxycytidine hydrochloride, gemcitabine hydrochloride
*Brand names: Gemcite, Gemzar, Infugem
==References==
Category:Drugs
Category:Intravenous medications
Category:Intravesical medications
Category:Irritant
Category:Neutral
Category:Antimetabolites
Category:Pyrimidine analogs
Category:Carcinoma of unknown primary medications
Category:Anaplastic large cell lymphoma medications
Category:Bladder cancer medications
Category:Breast cancer medications
Category:Cervical cancer medications
Category:Cholangiocarcinoma medications
Category:Diffuse large B-cell lymphoma medications
Category:Esophageal cancer medications
Category:Ewing sarcoma medications
Category:Extranodal NK- and T-cell lymphoma, nasal type medications
Category:Gallbladder cancer medications
Category:Hepatocellular carcinoma medications
Category:Classical Hodgkin lymphoma medications
Category:Leiomyosarcoma medications
Category:Malignant pleural mesothelioma medications
Category:Mantle cell lymphoma medications
Category:Nasopharyngeal carcinoma medications
Category:NK- and T-cell lymphoma medications
Category:Non-small cell lung cancer medications
Category:Non-small cell lung cancer, nonsquamous medications
Category:Non-small cell lung cancer, squamous medications
Category:Osteosarcoma medications
Category:Ovarian cancer medications
Category:Pancreatic cancer medications 
Category:Peripheral T-cell lymphoma medications
Category:Primary mediastinal B-cell lymphoma medications
Category:Renal_cell_carcinoma medications
Category:Sarcomatoid renal cell carcinoma medications
Category:Small cell lung cancer medications
Category:Soft tissue sarcoma medications 
Category:Testicular cancer medications
Category:Thymoma medications
Category:Transformed lymphoma medications
Category:Upper tract urothelial carcinoma medications
Category:Urothelial carcinoma medications
Category:FDA approved in 1996
Category:EMA approved in 1995
Category:WHO Essential Cancer Medicine