Difference between revisions of "Paclitaxel (Taxol)"

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==General information==
 
==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.  Paclitaxel is highly lipophilic/insoluble in water and needs to be dissolved in Cremophor EL (polyoxyethylated castor oil), which may cause hypersensitivity infusion reactions.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf Paclitaxel (Taxol) package insert]</ref><ref>[[Media:Paclitaxel.pdf | Paclitaxel (Taxol) package insert (locally hosted backup)]]</ref>
+
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.  Paclitaxel is highly lipophilic/insoluble in water and needs to be dissolved in Cremophor EL (polyoxyethylated castor oil), which may cause hypersensitivity infusion reactions.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf Paclitaxel (Taxol) package insert]</ref><ref>[[:File:Paclitaxel.pdf | Paclitaxel (Taxol) package insert (locally hosted backup)]]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: [[irritant]] (usually), [[vesicant]] (rare)  
 
<br>Extravasation: [[irritant]] (usually), [[vesicant]] (rare)  
  
 
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 ''(work in progress)''==
 +
*[[Breast cancer]]
 +
*[[Kaposi sarcoma]]
 +
*[[Non-small cell lung cancer]]
 +
**[[Non-small cell lung cancer, nonsquamous]]
 +
**[[Non-small cell lung cancer, squamous]]
 +
*[[Ovarian cancer]]
 +
**[[Low-grade serous ovarian cancer]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
 
<div style="column-count:3;-moz-column-count:3;-webkit-column-count:3">
 
<div style="column-count:3;-moz-column-count:3;-webkit-column-count:3">
−
*[[Adenocarcinoma of unknown primary]]
+
*[[Anal cancer]]
 +
*[[Angiosarcoma]]
 +
*[[Carcinoma of unknown primary]]
 +
*[[Cervical cancer]]
 
*[[Cutaneous basal cell carcinoma]]
 
*[[Cutaneous basal cell carcinoma]]
−
*[[Bladder cancer]]
 
−
*[[Breast cancer]]
 
−
*[[Cervical cancer]]
 
 
*[[Diffuse large B-cell lymphoma]]
 
*[[Diffuse large B-cell lymphoma]]
 +
*[[Endometrial cancer]]
 
*[[Esophageal cancer]]
 
*[[Esophageal cancer]]
 +
**[[Esophageal adenocarcinoma]]
 +
**[[Esophageal squamous cell carcinoma]]
 
*[[Gastric cancer]]
 
*[[Gastric cancer]]
 
*[[Head and neck cancer]]
 
*[[Head and neck cancer]]
−
*[[Kaposi sarcoma]]
+
*[[Melanoma]]
−
*[[Melanoma]]  
+
*[[Nasopharyngeal carcinoma]]
−
*[[Non-small cell lung cancer]]
 
−
*[[Ovarian cancer]]
 
−
**[[Low-grade serous ovarian cancer]]
 
 
*[[Penile cancer]]
 
*[[Penile cancer]]
 
*[[Prostate cancer]]
 
*[[Prostate cancer]]
−
*[[SCC of unknown primary]]
 
 
*[[Small cell lung cancer]]
 
*[[Small cell lung cancer]]
 
*[[Testicular cancer]]
 
*[[Testicular cancer]]
 
*[[Thymoma]]
 
*[[Thymoma]]
−
*[[Endometrial cancer]]
+
*[[Urothelial carcinoma]]
−
*[[Vascular sarcoma]]
+
**[[Bladder cancer]]
 
*[[Vulvar cancer]]
 
*[[Vulvar cancer]]
 
</div>
 
</div>
 
==Patient drug information==
 
==Patient drug information==
 
*[http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf Paclitaxel (Taxol) package insert]<ref name="insert"></ref>
 
*[http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf Paclitaxel (Taxol) package insert]<ref name="insert"></ref>
−
*[http://chemocare.com/chemotherapy/drug-info/Paclitaxel.aspx Paclitaxel (Taxol) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/Paclitaxel.aspx Paclitaxel (Taxol) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/Paclitaxel.aspx Paclitaxel (Taxol) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/Paclitaxel.aspx Paclitaxel (Taxol) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/paclitaxel-patient-drug-information Paclitaxel (Taxol) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/paclitaxel-patient-drug-information Paclitaxel (Taxol) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/paclitaxel-patient-drug-information Paclitaxel (Taxol) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/paclitaxel-patient-drug-information Paclitaxel (Taxol) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
* 12/29/1992: Initial FDA approval for treatment of patients with metastatic [[Ovarian cancer|carcinoma of the ovary]] after failure of first-line or subsequent chemotherapy
+
===[[Breast cancer]]===
−
* 4/9/1998 (earliest label available on Drugs @ FDA): Indicated for:
+
* 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the treatment of [[Breast cancer | breast cancer]] after failure of combination therapy for metastatic disease. Prior therapy should have included an [[:Category:Anthracyclines|anthracycline]] unless clinically contraindicated. ''(Based on Nabholtz et al. 1996)''
−
# First-line and subsequent therapy for the treatment of advanced [[Ovarian cancer | carcinoma of the ovary]]. As first-line therapy, Taxol is indicated in combination with [[Cisplatin (Platinol) | cisplatin]].
+
* 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the treatment of [[Breast cancer | breast cancer]] relapsed within 6 months of adjuvant chemotherapy. Prior therapy should have included an [[:Category:Anthracyclines|anthracycline]] unless clinically contraindicated. ''(Based on Nabholtz et al. 1996)''
−
# The treatment of [[Breast cancer | breast cancer]] after failure of combination therapy for metastatic disease or relapsed within 6 months of adjuvant chemotherapy. Prior therapy should have included an [[:Category:Anthracyclines|anthracycline]] unless clinically contraindicated.
+
* 1999-10-25: New indication for the adjuvant treatment of node-positive [[Breast cancer | breast cancer]] administered sequentially to standard [[Doxorubicin (Adriamycin) | doxorubicin]]-containing combination chemotherapy. ''(Based on INT 0148/CALGB 9344)''
−
# The second-line treatment of [[Kaposi sarcoma | AIDS-related Kaposi's sarcoma]].
+
===[[Ovarian cancer]]===
−
* 6/30/1998: New indication added: in combination with [[Cisplatin (Platinol) | cisplatin]], is indicated for the first-line treatment of [[Non-small cell lung cancer | non-small cell lung cancer]] in patients who are not candidates for potentially curative surgery and/or radiation therapy.
+
* 1992-12-29: Initial FDA approval for treatment of patients with metastatic [[Ovarian cancer|carcinoma of the ovary]] after failure of first-line or subsequent chemotherapy. ''(Based on Eisenhauer et al. 1994)''
−
* 10/25/1999: New indication for the adjuvant treatment of node-positive [[Breast cancer | breast cancer]] administered sequentially to standard [[Doxorubicin (Adriamycin) | doxorubicin]]-containing combination chemotherapy.
+
* 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for first-line therapy in combination with [[Cisplatin (Platinol) | cisplatin]] for the treatment of advanced [[Ovarian cancer | carcinoma of the ovary]]. ''(Based on GOG 111 & OV10)''
 +
* 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for subsequent therapy for the treatment of advanced [[Ovarian cancer | carcinoma of the ovary]]. ''(Based on GOG 111 & OV10)''
 +
===[[Kaposi sarcoma]]===
 +
* 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the second-line treatment of [[Kaposi sarcoma | AIDS-related Kaposi's sarcoma]]. ''(Based on CA139-174 & CA139-281)''
 +
===[[Non-small cell lung cancer]]===
 +
* 1998-06-30: New indication added: in combination with [[Cisplatin (Platinol) | cisplatin]], is indicated for the first-line treatment of [[non-small cell lung cancer]] in patients who are not candidates for potentially curative surgery and/or radiation therapy. ''(Based on ECOG E5592)''
 +
==History of changes in EMA indication==
 +
*1992-12-29: EURD
 +
==History of changes in PMDA indication==
 +
*2005-05-31: New indication for the treatment of [[endometrial cancer|cancer of the uterus body]].
 +
*2012-03-21: New additional indications and new dosages for the treatment of relapsed or metastatic [[head and neck cancer]].
 +
*2012-03-21: New additional indications and new dosages for the treatment of relapsed or metastatic [[Esophageal cancer|esophagus cancer]].
 +
*2012-03-21: New additional indications and new dosages for the treatment of [[angiosarcoma]].
 +
*2012-03-21: New additional indications and new dosages for the treatment of advanced or relapsed [[cervical cancer]].
 +
*2013-02-21: New additional indications and a new dosage for the treatment of relapsed or refractory germ cell tumors (testicular tumors, ovarian tumors, extragonadal tumors).
  
 
==Also known as==
 
==Also known as==
Line 55: Line 77:
 
|Anzatax
 
|Anzatax
 
|Anzatec
 
|Anzatec
 +
|Apealea
 
|Asotax
 
|Asotax
 
|Betaxel
 
|Betaxel
 
|Bristaxol
 
|Bristaxol
 +
|-
 
|Britaxol
 
|Britaxol
−
|-
 
 
|Clitaxel
 
|Clitaxel
 
|Cytax
 
|Cytax
Line 67: Line 90:
 
|Ebetaxel
 
|Ebetaxel
 
|Formoxol
 
|Formoxol
 +
|-
 
|Genexol
 
|Genexol
−
|-
 
 
|Genetaxyl
 
|Genetaxyl
 
|Gros
 
|Gros
Line 76: Line 99:
 
|Medixel
 
|Medixel
 
|Mitotax
 
|Mitotax
 +
|-
 
|Neotacs
 
|Neotacs
−
|-
 
 
|Neotaxan
 
|Neotaxan
 
|Neotaxl
 
|Neotaxl
Line 85: Line 108:
 
|Paclitax
 
|Paclitax
 
|Paclitaxin
 
|Paclitaxin
 +
|-
 
|Pacliteva
 
|Pacliteva
−
|-
 
 
|Pacxel
 
|Pacxel
 
|Padexol
 
|Padexol
Line 94: Line 117:
 
|Paxene
 
|Paxene
 
|Paxenor
 
|Paxenor
 +
|-
 
|Paxus
 
|Paxus
−
|-
+
|Pazenir
 
|Petaxel
 
|Petaxel
 
|Phyxol
 
|Phyxol
Line 102: Line 126:
 
|Ribotax
 
|Ribotax
 
|Sindaxel
 
|Sindaxel
 +
|-
 
|Taclipaxol
 
|Taclipaxol
 
|Tarvexol
 
|Tarvexol
−
|-
 
 
|Taxocris
 
|Taxocris
 
|Taxodiol
 
|Taxodiol
Line 111: Line 135:
 
|Taycovit
 
|Taycovit
 
|Unitaxel
 
|Unitaxel
 +
|-
 
|Yewtaxan
 
|Yewtaxan
 +
|Naveruclif
 
|-
 
|-
 
|}
 
|}
Line 127: Line 153:
 
[[Category:Microtubule inhibitors]]
 
[[Category:Microtubule inhibitors]]
  
−
[[Category:Adenocarcinoma of unknown primary medications]]  
+
[[Category:Anal cancer medications]]
−
[[Category:Cutaneous basal cell carcinoma medications]]
+
[[Category:Angiosarcoma medications]]  
 
[[Category:Bladder cancer medications]]
 
[[Category:Bladder cancer medications]]
 
[[Category:Breast cancer medications]]
 
[[Category:Breast cancer medications]]
 +
[[Category:Carcinoma of unknown primary medications]]
 
[[Category:Cervical cancer medications]]
 
[[Category:Cervical cancer medications]]
 +
[[Category:Cutaneous basal cell carcinoma medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Endometrial cancer medications]]
 
[[Category:Endometrial cancer medications]]
 +
[[Category:Esophageal adenocarcinoma medications]]
 
[[Category:Esophageal cancer medications]]
 
[[Category:Esophageal cancer medications]]
 +
[[Category:Esophageal squamous cell carcinoma medications]]
 
[[Category:Gastric cancer medications]]
 
[[Category:Gastric cancer medications]]
 
[[Category:Head and neck cancer medications]]
 
[[Category:Head and neck cancer medications]]
Line 140: Line 170:
 
[[Category:Low-grade serous ovarian cancer medications]]
 
[[Category:Low-grade serous ovarian cancer medications]]
 
[[Category:Melanoma medications]]  
 
[[Category:Melanoma medications]]  
 +
[[Category:Nasopharyngeal carcinoma medications]]
 
[[Category:Non-small cell lung cancer 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:Ovarian cancer medications]]
 
[[Category:Ovarian cancer medications]]
 
[[Category:Penile cancer medications]]  
 
[[Category:Penile cancer medications]]  
 
[[Category:Prostate cancer medications]]
 
[[Category:Prostate cancer medications]]
−
[[Category:SCC of unknown primary medications]]
 
 
[[Category:Small cell lung cancer medications]]
 
[[Category:Small cell lung cancer medications]]
 
[[Category:Testicular cancer medications]]
 
[[Category:Testicular cancer medications]]
 
[[Category:Thymoma medications]]
 
[[Category:Thymoma medications]]
−
[[Category:Vascular sarcoma medications]]  
+
[[Category:Urothelial carcinoma medications]]
 
[[Category:Vulvar cancer medications]]
 
[[Category:Vulvar cancer medications]]
  
 
[[Category:FDA approved in 1992]]
 
[[Category:FDA approved in 1992]]
 +
[[Category:EMA approved in 1992]]
 
[[Category:PMDA approved drugs]]
 
[[Category:PMDA approved drugs]]
 
[[Category:WHO Essential Cancer Medicine]]
 
[[Category:WHO Essential Cancer Medicine]]

Latest revision as of 17:50, 19 November 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. Paclitaxel is highly lipophilic/insoluble in water and needs to be dissolved in Cremophor EL (polyoxyethylated castor oil), which may cause hypersensitivity infusion reactions.[1][2]
Route: IV
Extravasation: irritant (usually), vesicant (rare)

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 (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Breast cancer

  • 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the treatment of breast cancer after failure of combination therapy for metastatic disease. Prior therapy should have included an anthracycline unless clinically contraindicated. (Based on Nabholtz et al. 1996)
  • 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the treatment of breast cancer relapsed within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. (Based on Nabholtz et al. 1996)
  • 1999-10-25: New indication for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. (Based on INT 0148/CALGB 9344)

Ovarian cancer

  • 1992-12-29: Initial FDA approval for treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. (Based on Eisenhauer et al. 1994)
  • 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for first-line therapy in combination with cisplatin for the treatment of advanced carcinoma of the ovary. (Based on GOG 111 & OV10)
  • 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for subsequent therapy for the treatment of advanced carcinoma of the ovary. (Based on GOG 111 & OV10)

Kaposi sarcoma

  • 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the second-line treatment of AIDS-related Kaposi's sarcoma. (Based on CA139-174 & CA139-281)

Non-small cell lung cancer

  • 1998-06-30: New indication added: in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. (Based on ECOG E5592)

History of changes in EMA indication

  • 1992-12-29: EURD

History of changes in PMDA indication

  • 2005-05-31: New indication for the treatment of cancer of the uterus body.
  • 2012-03-21: New additional indications and new dosages for the treatment of relapsed or metastatic head and neck cancer.
  • 2012-03-21: New additional indications and new dosages for the treatment of relapsed or metastatic esophagus cancer.
  • 2012-03-21: New additional indications and new dosages for the treatment of angiosarcoma.
  • 2012-03-21: New additional indications and new dosages for the treatment of advanced or relapsed cervical cancer.
  • 2013-02-21: New additional indications and a new dosage for the treatment of relapsed or refractory germ cell tumors (testicular tumors, ovarian tumors, extragonadal tumors).

Also known as

  • Brand names:
Synonyms
Abitaxel Altaxel Anzatax Anzatec Apealea Asotax Betaxel Bristaxol
Britaxol Clitaxel Cytax Daburex Dalys Drifen Ebetaxel Formoxol
Genexol Genetaxyl Gros Ifaxol Intaxel Magytax Medixel Mitotax
Neotacs Neotaxan Neotaxl Ofoxel Oncotaxel Onxol Paclitax Paclitaxin
Pacliteva Pacxel Padexol Paklitaxfil Panataxel Parexel Paxene Paxenor
Paxus Pazenir Petaxel Phyxol Poltaxel Praxel Ribotax Sindaxel
Taclipaxol Tarvexol Taxocris Taxodiol Taxol Taxomedac Taycovit Unitaxel
Yewtaxan Naveruclif

References

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