Difference between revisions of "Gemcitabine (Gemzar)"

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==General information==
 
==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.<ref name="insert">[http://pi.lilly.com/us/gemzar.pdf Gemcitabine (Gemzar) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/gemcitabine.pdf Gemcitabine (Gemzar) package insert (locally hosted backup)]</ref>
+
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.<ref name="insert">[http://pi.lilly.com/us/gemzar.pdf Gemcitabine (Gemzar) package insert]</ref><ref>[[:File:Gemcitabine.pdf|Gemcitabine (Gemzar) package insert (locally hosted backup)]]</ref>
 
<br>Route: IV
 
<br>Route: IV
−
<br>Extravasation: [[irritant]]
+
<br>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 such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>  
+
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.<ref name="insert"></ref>
 +
 
 +
==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==
 +
<div style="column-count:3;-moz-column-count:3;-webkit-column-count:3">
 +
*[[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]]
 +
</div>
  
 
==Patient drug information==
 
==Patient drug information==
 +
*[http://pi.lilly.com/us/gemzar.pdf Gemcitabine (Gemzar) package insert]<ref name="insert"></ref>
 
*[http://chemocare.com/bio/gemcitabine.asp Gemcitabine (Gemzar) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/gemcitabine.asp Gemcitabine (Gemzar) patient drug information (Chemocare)]</ref>
 
*[http://chemocare.com/bio/gemcitabine.asp Gemcitabine (Gemzar) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/gemcitabine.asp Gemcitabine (Gemzar) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/gemcitabine-patient-drug-information Gemcitabine (Gemzar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/gemcitabine-patient-drug-information Gemcitabine (Gemzar) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/gemcitabine-patient-drug-information Gemcitabine (Gemzar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/gemcitabine-patient-drug-information Gemcitabine (Gemzar) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
* 5/15/1996: Initial FDA approval
+
 
 +
===[[Breast cancer]]===
 +
* 2004-05-19: New FDA indication in combination with [[Paclitaxel (Taxol) | paclitaxel]] is indicated for the first-line treatment of patients with metastatic [[breast cancer]] after failure of prior [[Regimen_classes#Anthracycline-based_regimen|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 (Platinol) | 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 | 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 [[Regimen_classes#Platinum-based_regimen|platinum based therapy]]. ''(Based on AGO-OVAR 2.5)''
 +
* 2010-03-19: New FDA indication for [[ovarian cancer]] in combination with [[Carboplatin (Paraplatin) | carboplatin]]. ''(Prior exposure requirement removed; no supporting studies are cited)''
 +
* 2013-05-07: FDA indication revised: in combination with [[Carboplatin (Paraplatin) | carboplatin]], for the treatment of advanced [[Ovarian cancer | ovarian cancer]] that has relapsed at least 6 months after completion of [[Regimen_classes#Platinum-based_regimen|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) [[Pancreatic cancer | adenocarcinoma of the pancreas]]. ''(Based on Burris et al. 1997)''
 +
* 1996-05-15: Initial FDA approval for patients with [[Pancreatic cancer | adenocarcinoma of the pancreas]] previously treated with [[Regimen_classes#5-FU-based_regimen| 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 [[:Category:Biliary tract cancers|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 [[:Category:Lymphomas|malignant lymphoma]].
 +
 
 +
==Also known as==
 +
*'''Code name:''' LY-188011
 +
*'''Generic name:''' difluorodeoxycytidine hydrochloride, gemcitabine hydrochloride
 +
*'''Brand names:''' Gemcite, Gemzar, Infugem
  
 
==References==
 
==References==
 
<references/>
 
<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]]

Latest revision as of 00:59, 29 June 2024

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.[1][2]
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.[1]

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient drug information

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

  1. ↑ 1.0 1.1 1.2 Gemcitabine (Gemzar) package insert
  2. ↑ Gemcitabine (Gemzar) package insert (locally hosted backup)
  3. ↑ Gemcitabine (Gemzar) patient drug information (Chemocare)
  4. ↑ Gemcitabine (Gemzar) patient drug information (UpToDate)
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