Difference between revisions of "Gemcitabine (Gemzar)"

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===[[Breast cancer]]===
 
===[[Breast cancer]]===
* 5/15/1996: Initial FDA approval (original label not available on Drugs @ FDA) 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.
 
 
* 5/19/2004: New FDA indication in combination with [[Paclitaxel (Taxol) | paclitaxel]] is indicated for the first-line treatment of patients with metastatic [[Breast cancer | breast cancer]] after failure of prior [[Regimen_classes#Anthracycline-based_regimen|anthracycline-containing]] adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
 
* 5/19/2004: New FDA indication in combination with [[Paclitaxel (Taxol) | paclitaxel]] is indicated for the first-line treatment of patients with metastatic [[Breast cancer | breast cancer]] after failure of prior [[Regimen_classes#Anthracycline-based_regimen|anthracycline-containing]] adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
 
===[[Non-small cell lung cancer]]===
 
===[[Non-small cell lung cancer]]===
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* 5/7/2013: 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)''
 
* 5/7/2013: 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)''
 
===[[Pancreatic cancer]]===
 
===[[Pancreatic cancer]]===
* 8/25/1998: Indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) [[Pancreatic cancer | adenocarcinoma of the pancreas]]. Gemzar is indicated for patients previously treated with [[Regimen_classes#5-FU-based_regimen| 5-FU]].
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* 5/15/1996: 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]]; also indicated for patients previously treated with [[Regimen_classes#5-FU-based_regimen| 5-FU]].
  
 
==Also known as==
 
==Also known as==

Revision as of 01:01, 23 September 2020

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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Breast cancer

  • 5/19/2004: 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.

Non-small cell lung cancer

  • 8/25/1998: 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.

Ovarian cancer

Pancreatic cancer

  • 5/15/1996: 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; also indicated for patients previously treated with 5-FU.

Also known as

  • Code name: LY-188011
  • Generic name: difluorodeoxycytidine hydrochloride, gemcitabine hydrochloride
  • Brand names: Gemcite, Gemzar

References