Difference between revisions of "Eribulin (Halaven)"

Latest revision as of 01:05, 29 June 2024

General information

Class/mechanism: Non-taxane microtubule dynamics inhibitor. Inhibits the growth phase of microtubules and aggregates tubulin into inactive aggregates. Does not affect the shortening phase. Disruption of mitotic spindles interferes with mitosis, leads to G2/M cell-cycle block, and apoptotic cell death.^[1]^[2]^[3]
Route: IV
Extravasation: no information

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 or the prescribing information.^[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

2010-11-15: Initial approval for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. (Based on EMBRACE)
2016-01-28: Approved for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (Based on E7389-G000-309)

History of changes in EMA indication

2011-03-17: Initial marketing authorization as Halaven.

History of changes in Health Canada indication

2011-12-14: Initial notice of compliance for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane administered in either the adjuvant or metastatic setting.
2017-08-04: New indication for the treatment of adult patients with an unresectable advanced or metastatic liposarcoma subtype of soft tissue sarcoma. Prior therapy should have included an anthracycline-containing regimen, unless not clinically appropriate.

History of changes in PMDA indication

2011-04-22: Initial approval for the treatment of inoperable or recurrent breast cancer.
2016-02-29: New additional indication for the treatment of soft tissue sarcoma.

Also known as

Code names: E-7389, ER-086526, NSC-707389
Generic name: eribulin mesylate
Brand name: Brutravon, Ebunat, Epbriv, Halaven, Mitobulin, Rayldeima, Teceris

References

[insert-1] 1.0 ^1.1 ^1.2 Eribulin (Halaven) package insert

[2] Eribulin (Halaven) package insert (locally hosted backup)

[3] Halaven manufacturer's website

[4] Eribulin (Halaven) patient drug information (Chemocare)

[5] Eribulin (Halaven) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]

@@ Line 1: / Line 1: @@
 ==General information==
-Class/mechanism: Non-taxane microtubule dynamics inhibitor.  Inhibits the growth phase of microtubules and aggregates tubulin into inactive aggregates.  Does not affect the shortening phase.  Disruption of mitotic spindles interferes with mitosis, leads to G2/M cell-cycle block, and apoptotic cell death.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf Eribulin (Halaven) package insert]</ref><ref>[[:File:Eribulin.pdf | Eribulin (Halaven) package insert (locally hosted backup)]]</ref><ref>[http://halaven.com Halaven manufacturer's website]</ref>
+Class/mechanism: Non-taxane microtubule dynamics inhibitor. Inhibits the growth phase of microtubules and aggregates tubulin into inactive aggregates. Does not affect the shortening phase. Disruption of mitotic spindles interferes with mitosis, leads to G2/M cell-cycle block, and apoptotic cell death.<ref name="insert">[https://halaven.com/-/media/Files/Halaven/HALAVEN-Full-Prescribing-Information.pdf Eribulin (Halaven) package insert]</ref><ref>[[:File:Eribulin.pdf | Eribulin (Halaven) package insert (locally hosted backup)]]</ref><ref>[http://halaven.com Halaven manufacturer's website]</ref>
 <br>Route: IV
 <br>Extravasation: no information
-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 or the prescribing information.<ref name="insert"></ref>
 ==Diseases for which it is used==
 *[[Breast cancer]]
-*[[Leiomyosarcoma]]
+*[[Soft tissue sarcoma]]
-*[[Liposarcoma]]
+**[[Leiomyosarcoma]]
+**[[Liposarcoma]]
 ==Patient drug information==
-*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf#page=13 Eribulin (Halaven) package insert pages 13-16]<ref name="insert"></ref>
+*[https://halaven.com/-/media/Files/Halaven/HALAVEN-Full-Prescribing-Information.pdf Eribulin (Halaven) package insert]<ref name="insert"></ref>
-*[https://chemocare.com/chemotherapy/drug-info/eribulin.aspx Eribulin (Halaven) patient drug information (Chemocare)]<ref>[https://chemocare.com/chemotherapy/drug-info/eribulin.aspx Eribulin (Halaven) patient drug information (Chemocare)]</ref>
+*[https://chemocare.com/druginfo/eribulin.aspx Eribulin (Halaven) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/eribulin.aspx Eribulin (Halaven) patient drug information (Chemocare)]</ref>
 *[http://www.uptodate.com/contents/eribulin-patient-drug-information Eribulin (Halaven) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/eribulin-patient-drug-information Eribulin (Halaven) patient drug information (UpToDate)]</ref>
 ==History of changes in FDA indication==
-* 11/15/2010: Initial FDA approval for the treatment of patients with metastatic [[Breast cancer | breast cancer]] who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an [[Regimen_classes#Anthracycline-based_regimen|anthracycline]] and a [[Regimen_classes#Taxane-based_regimen|taxane]] in either the adjuvant or metastatic setting. ''(Based on EMBRACE)''
+* 2010-11-15: Initial approval for the treatment of patients with metastatic [[Breast cancer | breast cancer]] who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an [[Regimen_classes#Anthracycline-based_regimen|anthracycline]] and a [[Regimen_classes#Taxane-based_regimen|taxane]] in either the adjuvant or metastatic setting. ''(Based on EMBRACE)''
-* 1/28/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm483795.htm FDA approved] for the treatment of patients with unresectable or metastatic [[liposarcoma]] who have received a prior [[Regimen_classes#Anthracycline-based_regimen|anthracycline-containing regimen]]. ''(Based on E7389-G000-309)''
+* 2016-01-28: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm483795.htm Approved] for the treatment of patients with unresectable or metastatic [[liposarcoma]] who have received a prior [[Regimen_classes#Anthracycline-based_regimen|anthracycline-containing regimen]]. ''(Based on E7389-G000-309)''
 ==History of changes in EMA indication==
-*3/17/2011: Initial marketing authorization as Halaven.
+*2011-03-17: Initial marketing authorization as Halaven.
+==History of changes in Health Canada indication==
+*2011-12-14: Initial notice of compliance for the treatment of patients with metastatic [[breast cancer]] who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane administered in either the adjuvant or metastatic setting.
+*2017-08-04: New indication for the treatment of adult patients with an unresectable advanced or metastatic [[liposarcoma]] subtype of soft tissue sarcoma. Prior therapy should have included an anthracycline-containing regimen, unless not clinically appropriate.
+==History of changes in PMDA indication==
+*2011-04-22: Initial approval for the treatment of inoperable or recurrent [[breast cancer]].
+*2016-02-29: New additional indication for the treatment of [[soft tissue sarcoma]].
 ==Also known as==
-*'''Code names:''' E7389, ER-086526, NSC-707389
+*'''Code names:''' E-7389, ER-086526, NSC-707389
 *'''Generic name:''' eribulin mesylate
 *'''Brand name:''' Brutravon, Ebunat, Epbriv, Halaven, Mitobulin, Rayldeima, Teceris
@@ Line 38: / Line 44: @@
 [[Category:Leiomyosarcoma medications]]
 [[Category:Liposarcoma medications]]
+[[Category:Soft tissue sarcoma medications]]
 [[Category:EMA approved in 2011]]
 [[Category:FDA approved in 2010]]
+[[Category:Health Canada approved in 2011]]
+[[Category:PMDA approved in 2011]]