Difference between revisions of "Vincristine liposomal (Marqibo)"
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| − | ''' | + | '''FDA approved 8/9/2012.''' Also known as vincristine sulfate liposome injection. |
==General information== | ==General information== | ||
| − | Class/mechanism: Vinca alkaloid | + | 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> |
<br>Route: IV | <br>Route: IV | ||
| − | <br>Extravasation: | + | <br>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 [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. | + | 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 used== | ||
| + | *[[Acute lymphocytic leukemia]] | ||
| + | |||
| + | ==Clinical trials== | ||
| + | *[http://www.talontx.com/pipeline.php?divid=trialsummary Marqibo completed trials summary at Talon Therapeutics] | ||
| + | *[http://www.clinicaltrials.gov/ct2/show/NCT01439347 HALLMARQ, A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL] | ||
| + | *[http://www.clinicaltrials.gov/ct2/show/NCT00495079 HBS407, Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia] | ||
| + | *[http://www.clinicaltrials.gov/ct2/show/NCT00144963 VSLI-06, Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia] | ||
==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> | ||
*[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> | ||
==References== | ==References== | ||
<references/> | <references/> | ||
Revision as of 04:13, 13 August 2012
FDA approved 8/9/2012. Also known as vincristine sulfate liposome injection.
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
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)[5]
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
- ↑ Vincristine patient drug information - note: this is for the non-liposomal formulation (Chemocare)