Difference between revisions of "Irinotecan (Camptosar)"

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==General information==
 
==General information==
−
Class/mechanism: Topoisomerase I inhibitor; derivative of camptothecin, which interferes with topoisomerase I's normal action of relieving torsional strain in DNA by creating reversible
+
Class/mechanism: Topoisomerase I inhibitor; derivative of camptothecin, which interferes with topoisomerase I's normal action of relieving torsional strain in DNA by creating reversible single-strand breaks.  Irinotecan and its active metabolite SN-38 bind to the topoisomerase I & DNA complex and interfere with ligation of these single-strand breaks. Failure to repair these breaks eventually leads to double-strand DNA damage, which disrupts cell proliferation and leads to cell death.<ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=533 Irinotecan (Camptosar) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/irinotecan.pdf Irinotecan (Camptosar) package insert (locally hosted backup)]</ref>
−
single-strand breaks.  Irinotecan and its active metabolite SN-38 bind to the topoisomerase
 
−
I & DNA complex and interfere with ligation of these single-strand breaks. Failure to repair these breaks eventually leads to double-strand DNA damage, which disrupts cell proliferation and leads to cell death.<ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=533 Irinotecan (Camptosar) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/irinotecan.pdf Irinotecan (Camptosar) package insert (locally hosted backup)]</ref>
 
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: [[irritant]]
 
<br>Extravasation: [[irritant]]
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*[[Anaplastic glioma]]
 
*[[Anaplastic glioma]]
 
*[[Cervical cancer]]
 
*[[Cervical cancer]]
−
*[[Colon cancer]]
+
*[[Colorectal cancer]]
 +
**[[Rectal cancer]]
 
*[[Esophageal cancer]]
 
*[[Esophageal cancer]]
 +
**[[Esophageal adenocarcinoma]]
 +
**[[Esophageal squamous cell carcinoma]]
 
*[[Ewing sarcoma]]
 
*[[Ewing sarcoma]]
 +
*[[Gallbladder cancer]]
 
*[[Gastric cancer]]
 
*[[Gastric cancer]]
 
*[[Glioblastoma]]
 
*[[Glioblastoma]]
 +
*[[Hepatoblastoma]]
 
*[[Neuroblastoma]]
 
*[[Neuroblastoma]]
 
*[[Non-small cell lung cancer]]
 
*[[Non-small cell lung cancer]]
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==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
* 6/14/1996: Initial accelerated approval for the treatment of patients with metastatic carcinoma of the [[Colon cancer | colon]] or [[Rectal cancer | rectum]] whose disease has recurred or progressed following [[Fluorouracil (5-FU) | 5-FU-based]] therapy.
+
* 1996-06-14: Initial accelerated approval for the treatment of patients with metastatic [[Colorectal cancer|carcinoma of the colon or rectum]] whose disease has recurred or progressed following [[Fluorouracil (5-FU) | 5-FU-based]] therapy. ''(Based on Rothenberg et al. 1996, Pitot et al. 1997, Rougier et al. 1997, and Rothenberg et al. 1999)''
−
**10/22/1998: Converted to regular approval.
+
**1998-10-22: Converted to regular approval for the treatment of patients with metastatic [[Colorectal cancer|carcinoma of the colon or rectum]] whose disease has recurred or progressed following [[Fluorouracil (5-FU) | 5-FU-based]] therapy. ''(Based on V301 & V302)''
−
* 4/20/2000: Indicated as a component of first-line therapy in combination with [[Fluorouracil (5-FU) | 5-fluorouracil]] and [[Folinic acid (Leucovorin) | leucovorin]] for patients with metastatic carcinoma of the [[Colon cancer | colon]] or [[Rectal cancer | rectum]].
+
* 2000-04-20: Indicated as a component of first-line therapy in combination with [[Fluorouracil (5-FU) | 5-fluorouracil]] and [[Leucovorin (Folinic acid) | leucovorin]] for patients with metastatic [[Colorectal cancer|carcinoma of the colon or rectum]]. ''(Based on Douillard et al. 2000 & Saltz et al. 2000)''
−
* 4/20/2000: Also indicated for patients with metastatic carcinoma of the [[Colon cancer | colon]] or [[Rectal cancer | rectum]] whose disease has recurred or progressed following initial [[Fluorouracil (5-FU) | fluorouracil-based]] therapy.
+
==History of changes in EMA indication==
 +
*1995-05-05: EURD
 +
==History of changes in PMDA indication==
 +
*2013-03-25: New additional indication and a new dosage for the treatment of pediatric [[:Category:Malignant solid neoplasm|malignant solid tumor]].
 +
*2013-12-20: New additional indication and a new dosage for the treatment of unresectable [[pancreatic cancer]].
  
 
==Also known as==
 
==Also known as==
 +
*'''Generic name:''' irinotecan hydrochloride trihydrote
 
*'''Code names:''' Camptothecin-11, CPT-11, U-101440E
 
*'''Code names:''' Camptothecin-11, CPT-11, U-101440E
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*'''Brand names:''' Axinotecan, Biotecan, Biskam, Campto, Campostar, Camptosar, Elinatecan, Faultenocan, Irenax, Irinogen, Irinomedac, Irinotel, Irinotesin, Irnocam, Itoxaril, Linatecan, Onivyde, Satigene, Tecnotecan, Tekamen, Toptecin, Trinotecan, Winol
+
*'''Brand names:''' Axinotecan, Biotecan, Biskam, Campto, Campostar, Camptosar, Elinatecan, Faultenocan, Irenax, Irinogen, Irinomedac, Irinotel, Irinotesin, Irnocam, Itoxaril, Linatecan, Satigene, Tecnotecan, Tekamen, Toptecin, Trinotecan, Winol
  
 
==References==
 
==References==
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[[Category:Irritant]]
 
[[Category:Irritant]]
  
−
[[Category:Topoisomerase inhibitors]]
+
[[Category:Topoisomerase I inhibitors]]
  
 
[[Category:Carcinoma of unknown primary medications]]  
 
[[Category:Carcinoma of unknown primary medications]]  
 
[[Category:Anaplastic glioma medications]]  
 
[[Category:Anaplastic glioma medications]]  
 
[[Category:Cervical cancer medications]]
 
[[Category:Cervical cancer medications]]
−
[[Category:Colon cancer medications]]
+
[[Category:Colorectal cancer medications]]
 +
[[Category:Esophageal adenocarcinoma medications]]
 
[[Category:Esophageal cancer medications]]
 
[[Category:Esophageal cancer medications]]
 +
[[Category:Esophageal squamous cell carcinoma medications]]
 
[[Category:Ewing sarcoma medications]]
 
[[Category:Ewing sarcoma medications]]
 +
[[Category:Gallbladder cancer medications]]
 
[[Category:Gastric cancer medications]]
 
[[Category:Gastric cancer medications]]
 
[[Category:Glioblastoma medications]]
 
[[Category:Glioblastoma medications]]
 +
[[Category:Hepatoblastoma medications]]
 
[[Category:Neuroblastoma medications]]
 
[[Category:Neuroblastoma medications]]
 +
[[Category:Neuroendocrine carcinoma medications]]
 
[[Category:Non-small cell lung cancer medications]]
 
[[Category:Non-small cell lung cancer medications]]
 
[[Category:Pancreatic cancer medications]]  
 
[[Category:Pancreatic cancer medications]]  
−
[[Category:Penile cancer medications]]  
+
[[Category:Penile cancer medications]]
 +
[[Category:Rectal cancer medications]]
 
[[Category:Rhabdomyosarcoma medications]]
 
[[Category:Rhabdomyosarcoma medications]]
 
[[Category:Small cell lung cancer medications]]
 
[[Category:Small cell lung cancer medications]]
  
 
[[Category:FDA approved in 1996]]
 
[[Category:FDA approved in 1996]]
 +
[[Category:EMA approved in 1995]]
 
[[Category:WHO Essential Cancer Medicine]]
 
[[Category:WHO Essential Cancer Medicine]]

Revision as of 00:41, 7 November 2023

General information

Class/mechanism: Topoisomerase I inhibitor; derivative of camptothecin, which interferes with topoisomerase I's normal action of relieving torsional strain in DNA by creating reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I & DNA complex and interfere with ligation of these single-strand breaks. Failure to repair these breaks eventually leads to double-strand DNA damage, which disrupts cell proliferation and leads to cell death.[1][2]
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 used

Patient drug information

History of changes in FDA indication

  • 1996-06-14: Initial accelerated approval for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. (Based on Rothenberg et al. 1996, Pitot et al. 1997, Rougier et al. 1997, and Rothenberg et al. 1999)
  • 2000-04-20: Indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. (Based on Douillard et al. 2000 & Saltz et al. 2000)

History of changes in EMA indication

  • 1995-05-05: EURD

History of changes in PMDA indication

  • 2013-03-25: New additional indication and a new dosage for the treatment of pediatric malignant solid tumor.
  • 2013-12-20: New additional indication and a new dosage for the treatment of unresectable pancreatic cancer.

Also known as

  • Generic name: irinotecan hydrochloride trihydrote
  • Code names: Camptothecin-11, CPT-11, U-101440E
  • Brand names: Axinotecan, Biotecan, Biskam, Campto, Campostar, Camptosar, Elinatecan, Faultenocan, Irenax, Irinogen, Irinomedac, Irinotel, Irinotesin, Irnocam, Itoxaril, Linatecan, Satigene, Tecnotecan, Tekamen, Toptecin, Trinotecan, Winol

References

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