Difference between revisions of "Vincristine liposomal (Marqibo)"

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'''FDA approved 8/9/2012.'''
 
 
 
==General information==
 
==General information==
Class/mechanism: Vinca alkaloid which causes cell cycle arrest in metaphase and inhibits mitosis.  Vincristine stabilizes the spindle apparatus by binding to tubulin, alters microtubule structure and function, and inhibits chromosome separation.  Marqibo is a formulation of vincristine sulfate that is encapsulated in sphingomyelin/cholesterol liposomes (Optisomes), which are hypothesized to provide improved tissue drug penetration and reduced toxicity.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202497s000lbl.pdf Vincristine liposomal (Marqibo) package insert]</ref><ref>[[Media:Vincristineliposomal.pdf|Vincristine liposomal (Marqibo) package insert (locally hosted backup)]]</ref><ref>[http://www.marqibo.com/ Marqibo manufacturer's website]</ref><ref>[http://www.talontx.com/pipeline.php?divid=marqibo Talon Therapeutics's Marqibo site]</ref><ref>Jeffrey A. Silverman, Walter Aulitzky, John Lister, Lori Maness, Gary Schiller, Karen Seiter, Scott E. Smith, Wendy Stock, Dina Ben Yehuda, Steven R. Deitcher. Marqibo® (vincristine sulfate liposomes injection; VSLI) Optimizes the Dosing, Delivery, and Pharmacokinetic (PK) Profile of Vincristine Sulfate (VCR) in Adults with Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL). ASH 2010 abstract 2142. [http://files.shareholder.com/downloads/HNAB/0x0x425987/5F5A45E3-D917-4B1D-88CF-299164BE3344/ASH_PK_poster_2010_Final.pdf link to abstract]</ref>
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Class/mechanism: Vinca alkaloid which causes cell cycle arrest in metaphase and inhibits mitosis.  Vincristine stabilizes the spindle apparatus by binding to tubulin, alters microtubule structure and function, and inhibits chromosome separation.  Marqibo is a formulation of vincristine sulfate that is encapsulated in sphingomyelin/cholesterol liposomes (Optisomes), which are hypothesized to provide improved tissue drug penetration and reduced toxicity.<ref name="insert">[http://www.marqibo.com/pi/ Vincristine liposomal (Marqibo) package insert]</ref><ref>[[Media:Vincristineliposomal.pdf|Vincristine liposomal (Marqibo) package insert (locally hosted backup)]]</ref><ref>[http://www.marqibo.com/ Marqibo manufacturer's website]</ref><ref>Jeffrey A. Silverman, Walter Aulitzky, John Lister, Lori Maness, Gary Schiller, Karen Seiter, Scott E. Smith, Wendy Stock, Dina Ben Yehuda, Steven R. Deitcher. Marqibo® (vincristine sulfate liposomes injection; VSLI) Optimizes the Dosing, Delivery, and Pharmacokinetic (PK) Profile of Vincristine Sulfate (VCR) in Adults with Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL). ASH 2010 abstract 2142. [http://files.shareholder.com/downloads/HNAB/0x0x425987/5F5A45E3-D917-4B1D-88CF-299164BE3344/ASH_PK_poster_2010_Final.pdf link to abstract]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: [[irritant]]/[[vesicant]] (depending on reference)
 
<br>Extravasation: [[irritant]]/[[vesicant]] (depending on reference)
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==Patient drug information==
 
==Patient drug information==
*Patient counseling information is available on [http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202497s000lbl.pdf#page=17 pages 17-20 of the package insert].<ref name="insert"></ref>
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*Brief patient counseling information is available in [http://www.marqibo.com/pi/ the Vincristine liposomal (Marqibo) package insert].<ref name="insert"></ref>
*[http://chemocare.com/bio/vincristine.asp Vincristine patient drug information - note: this is for the non-liposomal formulation (Chemocare)]<ref>[http://chemocare.com/bio/vincristine.asp Vincristine patient drug information - note: this is for the non-liposomal formulation (Chemocare)]</ref>
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*[http://www.chemocare.com/chemotherapy/drug-info/vincristine-liposomal.aspx Vincristine liposomal (Marqibo) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/chemotherapy/drug-info/vincristine-liposomal.aspx Vincristine liposomal (Marqibo) patient drug information (Chemocare)]</ref>
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==History of changes in FDA indication==
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*8/9/2012: FDA approved "for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) [[B-cell acute lymphoblastic leukemia|acute lymphoblastic leukemia (ALL)]] in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies."<ref name="insert"></ref>
  
 
==Also known as==
 
==Also known as==

Revision as of 04:58, 27 April 2017

General information

Class/mechanism: Vinca alkaloid which causes cell cycle arrest in metaphase and inhibits mitosis. Vincristine stabilizes the spindle apparatus by binding to tubulin, alters microtubule structure and function, and inhibits chromosome separation. Marqibo is a formulation of vincristine sulfate that is encapsulated in sphingomyelin/cholesterol liposomes (Optisomes), which are hypothesized to provide improved tissue drug penetration and reduced toxicity.[1][2][3][4]
Route: IV
Extravasation: irritant/vesicant (depending on reference)

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

Clinical trials

Patient drug information

History of changes in FDA indication

  • 8/9/2012: FDA approved "for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies."[1]

Also known as

Vincristine sulfate liposome injection, VSLI.

References

  1. 1.0 1.1 1.2 1.3 Vincristine liposomal (Marqibo) package insert
  2. Vincristine liposomal (Marqibo) package insert (locally hosted backup)
  3. Marqibo manufacturer's website
  4. Jeffrey A. Silverman, Walter Aulitzky, John Lister, Lori Maness, Gary Schiller, Karen Seiter, Scott E. Smith, Wendy Stock, Dina Ben Yehuda, Steven R. Deitcher. Marqibo® (vincristine sulfate liposomes injection; VSLI) Optimizes the Dosing, Delivery, and Pharmacokinetic (PK) Profile of Vincristine Sulfate (VCR) in Adults with Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL). ASH 2010 abstract 2142. link to abstract
  5. Vincristine liposomal (Marqibo) patient drug information (Chemocare)