Difference between revisions of "Trabectedin (Yondelis)"

Latest revision as of 12:11, 29 June 2024

General information

Class/mechanism: Alkylator, binds to the minor groove of DNA, which distorts the DNA helix and its major groove. This binding interrupts normal cell function and interferes with the expression of several several transcription factors, DNA binding proteins, and DNA repair mechanisms, which interrupts cell cycle and leads to tumor death.^[1]^[2]^[3]
Route: IV
Extravasation: vesicant

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

2015-10-23: Approved for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have received a prior anthracycline-containing regimen. (Based on ET743-SAR-3007)

History of changes in EMA indication

2007-09-17: Initial authorization

History of changes in Health Canada indication

2010-05-13: Initial notice of compliance

History of changes in PMDA indication

2015-09-28: Initial approval for the treatment of patients with soft tissue sarcoma.

Also known as

Code name: ET-743
Brand name: Yondelis

References

[insert-1] 1.0 ^1.1 ^1.2 Trabectedin (Yondelis) package insert

[2] Trabectedin (Yondelis) package insert (locally hosted backup)

[3] Yondelis manufacturer's website

[4] Trabectedin (Yondelis) patient drug information from manufacturer

[5] Trabectedin (Yondelis) patient drug information (Chemocare)

[6] Trabectedin (Yondelis) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]

[6]

@@ Line 1: / Line 1: @@
 ==General information==
-Class/mechanism: Binds to the minor groove of DNA, which distorts the DNA helix and its major groove.  This binding interrupts normal cell function and interferes with the expression of several several transcription factors, DNA binding proteins, and DNA repair mechanisms, which interrupts cell cycle and leads to tumor death.<ref name="insert">[http://www.yondelis.com/prescribing-information.pdf Trabectedin (Yondelis) package insert]</ref><ref>[[Media:Trabectedin.pdf|Trabectedin (Yondelis) package insert (locally hosted backup)]]</ref><ref>[https://www.yondelis.com/ Yondelis manufacturer's website]</ref>
+Class/mechanism: Alkylator, binds to the minor groove of DNA, which distorts the DNA helix and its major groove.  This binding interrupts normal cell function and interferes with the expression of several several transcription factors, DNA binding proteins, and DNA repair mechanisms, which interrupts cell cycle and leads to tumor death.<ref name="insert">[https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/YONDELIS-pi.pdf Trabectedin (Yondelis) package insert]</ref><ref>[[:File:Trabectedin.pdf|Trabectedin (Yondelis) package insert (locally hosted backup)]]</ref><ref>[https://www.yondelis.com/ Yondelis manufacturer's website]</ref>
 <br>Route: IV
 <br>Extravasation: [[vesicant]]
-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 Micromedex, 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==
+*[[Leiomyosarcoma]]
+*[[Liposarcoma]]
 *[[Ovarian cancer]]
 *[[Soft tissue sarcoma]]
 ==Patient drug information==
-*[http://www.yondelis.com/prescribing-information.pdf Trabectedin (Yondelis) package insert]<ref name="insert"></ref>
+*[https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/YONDELIS-pi.pdf Trabectedin (Yondelis) package insert]<ref name="insert"></ref>
-*[https://www.yondelis.com/patients Trabectedin (Yondelis) patient drug information from manufacturer]<ref>[https://www.yondelis.com/patients Trabectedin (Yondelis) patient drug information from manufacturer]</ref>
+*[https://www.yondelis.com/patient Trabectedin (Yondelis) patient drug information from manufacturer]<ref>[https://www.yondelis.com/patient Trabectedin (Yondelis) patient drug information from manufacturer]</ref>
-*[http://chemocare.com/chemotherapy/drug-info/trabectedin.aspx Trabectedin (Yondelis) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/trabectedin.aspx Trabectedin (Yondelis) patient drug information (Chemocare)]</ref>
+*[https://chemocare.com/druginfo/trabectedin.aspx Trabectedin (Yondelis) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/trabectedin.aspx Trabectedin (Yondelis) patient drug information (Chemocare)]</ref>
 *[http://www.uptodate.com/contents/trabectedin-patient-drug-information Trabectedin (Yondelis) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/trabectedin-patient-drug-information Trabectedin (Yondelis) patient drug information (UpToDate)]</ref>
 ==History of changes in FDA indication==
-* 9/30/2004: Granted orphan status for treatment of [[Soft tissue sarcoma | soft tissue sarcoma]].
+* 2015-10-23: [https://pubmed.ncbi.nlm.nih.gov/28774898/ Approved] for the treatment of patients with unresectable or metastatic [[liposarcoma]] or [[leiomyosarcoma]] who have received a prior [[Regimen_classes#Anthracycline-based_regimen|anthracycline-containing regimen]]. ''(Based on ET743-SAR-3007)''
-* 3/29/2005: Granted orphan status for treatment of patients with [[Ovarian cancer | ovarian cancer]].
+==History of changes in EMA indication==
-* 10/23/2015: FDA approved "for the treatment of patients with unresectable or metastatic [[Soft tissue sarcoma|liposarcoma or leiomyosarcoma]] who have received a prior [[:Category:Anthracyclines|anthracycline-]]containing regimen"
+*2007-09-17: Initial authorization
+==History of changes in Health Canada indication==
+*2010-05-13: Initial notice of compliance
+==History of changes in PMDA indication==
+*2015-09-28: Initial approval for the treatment of patients with [[soft tissue sarcoma]].
 ==Also known as==
 *'''Code name:''' ET-743
@@ Line 31: / Line 36: @@
 [[Category:Intravenous medications]]
 [[Category:Vesicant]]
-[[Category:Orphan drug]]
+[[Category:Alkylating agents]]
+[[Category:Leiomyosarcoma medications]]
+[[Category:Liposarcoma medications]]
 [[Category:Ovarian cancer medications]]
 [[Category:Soft tissue sarcoma medications]]
+[[Category:EMA approved in 2007]]
 [[Category:FDA approved in 2015]]
+[[Category:Health Canada approved in 2010]]
+[[Category:PMDA approved in 2015]]