Difference between revisions of "Topotecan (Hycamtin)"
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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 ''(work in progress)''== | ||
| + | *[[Cervical cancer]] | ||
| + | *[[Ovarian cancer]] | ||
| + | **[[Low-grade serous ovarian cancer]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | |||
*[[CNS lymphoma]] | *[[CNS lymphoma]] | ||
*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
*[[Ewing sarcoma]] | *[[Ewing sarcoma]] | ||
| + | *[[Medulloblastoma]] | ||
| + | *[[Neuroblastoma]] | ||
*[[Osteosarcoma]] | *[[Osteosarcoma]] | ||
| − | |||
| − | |||
*[[Small cell lung cancer]] | *[[Small cell lung cancer]] | ||
*[[Endometrial cancer]] | *[[Endometrial cancer]] | ||
| Line 22: | Line 26: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | * 1996-05-28: Initial FDA approval for metastatic [[Ovarian cancer | carcinoma of the ovary]] after failure of initial or subsequent chemotherapy. ''(Based on Bookman et al. 1996 & ten Bokkel Huinink et al. 1997)'' |
| − | * 11 | + | * 1998-11-30: Indication expanded to include [[Small cell lung cancer | small cell lung cancer]] sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy. ''(Based on von Pawel et al. 1999)'' |
| − | * | + | * 2006-06-14: Indication expanded to include stage IV-B, recurrent, or persistent [[Cervical cancer | carcinoma of the cervix]] which is not amenable to curative treatment with surgery and/or radiation therapy. ''(Based on GOG 179)'' |
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | * 1996-11-12: Initial marketing authorization as Hycamtin. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2011-02-23: New additional indication and a new dosage for the treatment of [[ovarian cancer]] which has progressed after cancer chemotherapy. | ||
| + | *2013-06-14: New additional indication and a new dosage for the treatment of pediatric [[:Category:Malignant solid neoplasm|malignant solid tumors]]. | ||
| + | *2015-11-20: New additional indication and a new dosage for the treatment of advanced or recurrent [[cervical cancer]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' SKF S-104864-A | *'''Code name:''' SKF S-104864-A | ||
| − | *'''Brand names:''' Hycamtin, Topecan, Topotec | + | *'''Generic name:''' nogitecan hydrochloride |
| + | *'''Brand names:''' Evotopin, Hycamtin, Potactasol, Topecan, Topotec | ||
==References== | ==References== | ||
| Line 37: | Line 49: | ||
[[Category:Irritant]] | [[Category:Irritant]] | ||
| − | [[Category:Topoisomerase inhibitors]] | + | [[Category:Topoisomerase I inhibitors]] |
[[Category:CNS lymphoma medications]] | [[Category:CNS lymphoma medications]] | ||
| Line 44: | Line 56: | ||
[[Category:Endometrial cancer medications]] | [[Category:Endometrial cancer medications]] | ||
[[Category:Ewing sarcoma medications]] | [[Category:Ewing sarcoma medications]] | ||
| − | [[Category:Low-grade serous ovarian cancer]] | + | [[Category:Low-grade serous ovarian cancer medications]] |
| + | [[Category:Medulloblastoma medications]] | ||
| + | [[Category:Neuroblastoma medications]] | ||
[[Category:Osteosarcoma medications]] | [[Category:Osteosarcoma medications]] | ||
[[Category:Ovarian cancer medications]] | [[Category:Ovarian cancer medications]] | ||
[[Category:Small cell lung cancer medications]] | [[Category:Small cell lung cancer medications]] | ||
| + | [[Category:EMA approved in 1996]] | ||
[[Category:FDA approved in 1996]] | [[Category:FDA approved in 1996]] | ||
Revision as of 00:28, 7 November 2023
General information
Class/mechanism: Topoisomerase I inhibitor. Topotecan binds to the topoisomerase I-DNA complex and prevents the religation of single strand breaks that were originally created by topoisomerase I. This leads to double strand DNA damage, which results in cell damage and 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 established (work in progress)
Diseases for which it is used
- CNS lymphoma
- Diffuse large B-cell lymphoma
- Ewing sarcoma
- Medulloblastoma
- Neuroblastoma
- Osteosarcoma
- Small cell lung cancer
- Endometrial cancer
Patient drug information
- Topotecan (Hycamtin) patient drug information (Chemocare)[3]
- Topotecan (Hycamtin) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 1996-05-28: Initial FDA approval for metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. (Based on Bookman et al. 1996 & ten Bokkel Huinink et al. 1997)
- 1998-11-30: Indication expanded to include small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy. (Based on von Pawel et al. 1999)
- 2006-06-14: Indication expanded to include stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. (Based on GOG 179)
History of changes in EMA indication
- 1996-11-12: Initial marketing authorization as Hycamtin.
History of changes in PMDA indication
- 2011-02-23: New additional indication and a new dosage for the treatment of ovarian cancer which has progressed after cancer chemotherapy.
- 2013-06-14: New additional indication and a new dosage for the treatment of pediatric malignant solid tumors.
- 2015-11-20: New additional indication and a new dosage for the treatment of advanced or recurrent cervical cancer.
Also known as
- Code name: SKF S-104864-A
- Generic name: nogitecan hydrochloride
- Brand names: Evotopin, Hycamtin, Potactasol, Topecan, Topotec
References
Categories:
- Drugs
- Intravenous medications
- Irritant
- Topoisomerase I inhibitors
- CNS lymphoma medications
- Cervical cancer medications
- Diffuse large B-cell lymphoma medications
- Endometrial cancer medications
- Ewing sarcoma medications
- Low-grade serous ovarian cancer medications
- Medulloblastoma medications
- Neuroblastoma medications
- Osteosarcoma medications
- Ovarian cancer medications
- Small cell lung cancer medications
- EMA approved in 1996
- FDA approved in 1996