Difference between revisions of "Vincristine liposomal (Marqibo)"
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| − | '''FDA approved 8/9/2012.''' | + | '''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> | 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> | ||
<br>Route: IV | <br>Route: IV | ||
| − | <br>Extravasation: [[irritant]] | + | <br>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 [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> | ||
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*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> | *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> | ||
*[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> | *[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> | ||
| + | |||
| + | ==Also known as== | ||
| + | Vincristine sulfate liposome injection, VSLI. | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| + | |||
| + | [[Category:Drug index]] | ||
| + | [[Category:Chemotherapy]] | ||
| + | |||
| + | [[Category:Irritant chemotherapy]] | ||
| + | [[Category:Vesicant chemotherapy]] | ||
| + | |||
| + | [[Category:Microtubule inhibitors]] | ||
| + | [[Category:Vinca alkaloids]] | ||
| + | [[Category:Acute lymphocytic leukemia medications]] | ||
| + | [[Category:Drugs FDA approved in 2012]] | ||
Revision as of 03:12, 16 August 2013
FDA approved 8/9/2012.
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][5]
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
- Marqibo completed trials summary at Talon Therapeutics
- HALLMARQ, A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL
- HBS407, Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia
- VSLI-06, Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Patient drug information
- Patient counseling information is available on pages 17-20 of the package insert.[1]
- Vincristine patient drug information - note: this is for the non-liposomal formulation (Chemocare)[6]
Also known as
Vincristine sulfate liposome injection, VSLI.
References
- ↑ 1.0 1.1 1.2 Vincristine liposomal (Marqibo) package insert
- ↑ Vincristine liposomal (Marqibo) package insert (locally hosted backup)
- ↑ Marqibo manufacturer's website
- ↑ Talon Therapeutics's Marqibo site
- ↑ 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
- ↑ Vincristine patient drug information - note: this is for the non-liposomal formulation (Chemocare)