Difference between revisions of "Irinotecan (Camptosar)"

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)
- 1998-10-22: Converted to regular 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 V301 & V302)
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

[insert-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)

[1]

[2]

[3]

[4]

@@ Line 1: / Line 1: @@
 ==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>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 [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 used==
-*[[Bone cancer]]
+*[[Carcinoma of unknown primary]]
-*[[Central nervous system (CNS) cancer]]
+*[[Anaplastic glioma]]
 *[[Cervical cancer]]
-*[[Colon cancer]]
+*[[Colorectal cancer]]
+**[[Rectal cancer]]
 *[[Esophageal cancer]]
+**[[Esophageal adenocarcinoma]]
+**[[Esophageal squamous cell carcinoma]]
+*[[Ewing sarcoma]]
+*[[Gallbladder cancer]]
+*[[Gastric cancer]]
+*[[Glioblastoma]]
+*[[Hepatoblastoma]]
+*[[Neuroblastoma]]
+*[[Non-small cell lung cancer]]
 *[[Pancreatic cancer]]
 *[[Penile cancer]]
+*[[Rhabdomyosarcoma]]
 *[[Small cell lung cancer]]
-*[[Unknown primary]]
 ==Patient drug information==
+*[http://labeling.pfizer.com/ShowLabeling.aspx?id=533 Irinotecan (Camptosar) package insert]<ref name="insert"></ref>
 *[http://chemocare.com/bio/irinotecan.asp Irinotecan (Camptosar) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/irinotecan.asp Irinotecan (Camptosar) patient drug information (Chemocare)]</ref>
 *[http://www.uptodate.com/contents/irinotecan-patient-drug-information Irinotecan (Camptosar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/irinotecan-patient-drug-information Irinotecan (Camptosar) patient drug information (UpToDate)]</ref>
 ==History of changes in FDA indication==
-* 6/14/1996: Initial FDA 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)''
-* 4/20/2000: Colon cancer indication revised:
+**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)''
-** 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)''
-** 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==
+*'''Generic name:''' irinotecan hydrochloride trihydrote
-{| border="1" style="text-align:center;"
+*'''Code names:''' Camptothecin-11, CPT-11, U-101440E
-!colspan="5" align="center" style="background-color:#0066FF"| '''Synonyms'''
+*'''Brand names:''' Axinotecan, Biotecan, Biskam, Campto, Campostar, Camptosar, Elinatecan, Faultenocan, Irenax, Irinogen, Irinomedac, Irinotel, Irinotesin, Irnocam, Itoxaril, Linatecan, Satigene, Tecnotecan, Tekamen, Toptecin, Trinotecan, Winol
-|-
-|Campto Conc
-|Camptosar
-|Cloridrato DE Irinotecano
-|CPT-11
-|Elinatecan
-|-
-|Faultenocan
-|Irenax
-|Irinogen
-|Irinotecan Hydrochloride
-|Irinotecan Mayne
-|-
-|Irinotecan Rovi
-|Irinotel
-|Irnocam
-|Itoxaril
-|Linatecan
-|-
-|Satigene
-|Tecnotecan
-|Topotecin
-|Trinotecan
-|Winol
-|}
 ==References==
 <references/>
-[[Category:Drug index]]
+[[Category:Drugs]]
-[[Category:Chemotherapy]]
+[[Category:Intravenous medications]]
-[[Category:Intravenous chemotherapy]]
+[[Category:Irritant]]
-[[Category:Irritant chemotherapy]]
-[[Category:Topoisomerase inhibitors]]
+[[Category:Topoisomerase I inhibitors]]
-[[Category:Bone cancer medications]]
+[[Category:Carcinoma of unknown primary medications]]
-[[Category:Cancer of unknown primary medications]]
+[[Category:Anaplastic glioma medications]]
-[[Category:Central nervous system (CNS) cancer medications]]
 [[Category:Cervical cancer medications]]
-[[Category:Colon cancer medications]]
+[[Category:Colorectal cancer medications]]
+[[Category:Esophageal adenocarcinoma medications]]
 [[Category:Esophageal cancer medications]]
+[[Category:Esophageal squamous cell carcinoma medications]]
+[[Category:Ewing sarcoma medications]]
+[[Category:Gallbladder cancer medications]]
+[[Category:Gastric cancer medications]]
+[[Category:Glioblastoma medications]]
+[[Category:Hepatoblastoma medications]]
+[[Category:Neuroblastoma medications]]
+[[Category:Neuroendocrine carcinoma medications]]
+[[Category:Non-small cell lung cancer medications]]
 [[Category:Pancreatic cancer medications]]
 [[Category:Penile cancer medications]]
+[[Category:Rectal cancer medications]]
+[[Category:Rhabdomyosarcoma medications]]
 [[Category:Small cell lung cancer medications]]
-[[Category:Drugs FDA approved in 1996]]
+[[Category:FDA approved in 1996]]
+[[Category:EMA approved in 1995]]
+[[Category:WHO Essential Cancer Medicine]]