Difference between revisions of "Paclitaxel, nanoparticle albumin-bound (Abraxane)"
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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 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> | ||
| + | |||
| + | ==Diseases for which it is established== | ||
| + | *[[Breast cancer]] | ||
| + | *[[Non-small cell lung cancer]] | ||
| + | *[[Pancreatic cancer]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | |||
| − | |||
*[[Gallbladder cancer]] | *[[Gallbladder cancer]] | ||
*[[Gastric cancer]] | *[[Gastric cancer]] | ||
*[[Melanoma]] | *[[Melanoma]] | ||
| − | + | *[[Non-small cell lung cancer, nonsquamous]] | |
| − | + | *[[Non-small cell lung cancer, squamous]] | |
| − | |||
*[[Ovarian cancer]] | *[[Ovarian cancer]] | ||
| − | *[[ | + | *[[Urothelial carcinoma]] |
==Patient drug information== | ==Patient drug information== | ||
| Line 24: | Line 26: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *2005-01-07: FDA approved for metastatic [[ | + | *2005-01-07: FDA approved for metastatic [[breast cancer]], after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an [[Regimen_classes#Anthracycline-based_regimen|anthracycline]] unless clinically contraindicated. ''(Based on CA012-0 & Ibrahim et al. 2005)'' |
*2012-10-11: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm323668.htm FDA approved] for locally advanced or metastatic [[Non-small cell lung cancer | Non-Small Cell Lung Cancer (NSCLC)]], as first-line treatment in combination with [[Carboplatin (Paraplatin) | carboplatin]], in patients who are not candidates for curative surgery or radiation therapy. ''(Based on CA031)'' | *2012-10-11: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm323668.htm FDA approved] for locally advanced or metastatic [[Non-small cell lung cancer | Non-Small Cell Lung Cancer (NSCLC)]], as first-line treatment in combination with [[Carboplatin (Paraplatin) | carboplatin]], in patients who are not candidates for curative surgery or radiation therapy. ''(Based on CA031)'' | ||
*2013-09-06: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367442.htm FDA approved] for treatment of metastatic [[Pancreatic cancer | adenocarcinoma of the pancreas]] as first-line treatment, in combination with [[Gemcitabine (Gemzar) | gemcitabine]]. ''(Based on MPACT)'' | *2013-09-06: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367442.htm FDA approved] for treatment of metastatic [[Pancreatic cancer | adenocarcinoma of the pancreas]] as first-line treatment, in combination with [[Gemcitabine (Gemzar) | gemcitabine]]. ''(Based on MPACT)'' | ||
| Line 54: | Line 56: | ||
[[Category:Taxanes]] | [[Category:Taxanes]] | ||
| − | |||
[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
[[Category:Gallbladder cancer medications]] | [[Category:Gallbladder cancer medications]] | ||
| Line 64: | Line 65: | ||
[[Category:Ovarian cancer medications]] | [[Category:Ovarian cancer medications]] | ||
[[Category:Pancreatic cancer medications]] | [[Category:Pancreatic cancer medications]] | ||
| + | [[Category:Urothelial carcinoma medications]] | ||
[[Category:EMA approved in 2008]] | [[Category:EMA approved in 2008]] | ||
Revision as of 13:08, 9 September 2023
General information
Class/mechanism: Taxane, promotes assembly of microtubules, stablizes microtubules, preventing depolymerization. Paclitaxel interferes with the normal dynamic reorganization of microtubules that is necessary for regular interphase/mitosis processes. It also leads to creation of abnormal bundles of microtubules. The nanoparticle albumin bound characteristic of Abraxane eliminates the need for it to be dissolved in Cremophor EL (polyoxyethylated castor oil) like Paclitaxel (Taxol) and the risk of hypersensitivity infusion reactions related to Cremophor.[1][2][3]
Route: IV
Extravasation: irritant
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 established
Diseases for which it is used
- Gallbladder cancer
- Gastric cancer
- Melanoma
- Non-small cell lung cancer, nonsquamous
- Non-small cell lung cancer, squamous
- Ovarian cancer
- Urothelial carcinoma
Patient drug information
- Paclitaxel, nanoparticle albumin-bound (Abraxane) package insert[1]
- Paclitaxel, nanoparticle albumin-bound (Abraxane) patient drug information (Chemocare)[4]
- Paclitaxel, nanoparticle albumin-bound (Abraxane) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2005-01-07: FDA approved for metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. (Based on CA012-0 & Ibrahim et al. 2005)
- 2012-10-11: FDA approved for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. (Based on CA031)
- 2013-09-06: FDA approved for treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. (Based on MPACT)
History of changes in EMA indication
- 2008-01-11: Initial marketing authorization as Abraxane
History of changes in Health Canada indication
- 2006-06-07: Initial notice of compliance (unclear details)
- 2014-07-16: New indication for the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
History of changes in PMDA indication
- 2010-07-23: Initial approval in a new dosage form and with a new dosage indicated for the treatment of breast cancer.
- 2013-02-21: New additional indications and a new dosage for the treatment of gastric cancer and non-small cell lung cancer.
- 2014-12-18: New additional indication and a new dosage for the treatment of unresectable pancreatic cancer.
Also known as
- Code name: ABI-007
- Generic names: ab-pac, ab-paclitaxel, albumin-bound paclitaxel, nab-paclitaxel, paclitaxel protein-bound, paclitaxel protein-bound particles for injectable suspension (albumin-bound)
- Brand name: Abraxane
References
- ↑ 1.0 1.1 1.2 Paclitaxel, nanoparticle albumin-bound (Abraxane) package insert
- ↑ Paclitaxel, nanoparticle albumin-bound (Abraxane) package insert (locally hosted backup)
- ↑ Abraxane manufacturer's website
- ↑ Paclitaxel, nanoparticle albumin-bound (Abraxane) patient drug information (Chemocare)
- ↑ Paclitaxel, nanoparticle albumin-bound (Abraxane) patient drug information (UpToDate)
Categories:
- Drugs
- Intravenous medications
- Irritant
- Nanoparticle albumin bound chemotherapy
- Microtubule inhibitors
- Taxanes
- Breast cancer medications
- Gallbladder cancer medications
- Gastric cancer medications
- Melanoma medications
- Non-small cell lung cancer medications
- Non-small cell lung cancer, nonsquamous medications
- Non-small cell lung cancer, squamous medications
- Ovarian cancer medications
- Pancreatic cancer medications
- Urothelial carcinoma medications
- EMA approved in 2008
- FDA approved in 2005
- Health Canada approved in 2006
- PMDA approved in 2010