Difference between revisions of "Vincristine liposomal (Marqibo)"
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==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://marqibo.com/wp-content/uploads/2019/11/MARQIBO-PI-06-2020-REF-0081.pdf Vincristine liposomal (Marqibo) package insert]</ref><ref>[[:File: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: | + | <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. | + | 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, or the prescribing information.<ref name="insert"></ref> |
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| + | ==Diseases for which it was used== | ||
| + | *[[B-cell acute lymphoblastic leukemia - historical|B-cell acute lymphoblastic leukemia]] | ||
| + | *[[Diffuse large B-cell lymphoma - historical|Diffuse large B-cell lymphoma]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[http://chemocare.com/ | + | *Brief patient counseling information is available in [http://www.marqibo.com/pi/ the Vincristine liposomal (Marqibo) package insert].<ref name="insert"></ref> |
| + | *[https://chemocare.com/druginfo/vincristine-liposomal.aspx Vincristine liposomal (Marqibo) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/vincristine-liposomal.aspx Vincristine liposomal (Marqibo) patient drug information (Chemocare)]</ref> | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *2012-08-09: Accelerated approval 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. ''(Based on RALLY)'' | ||
| + | **2022-05-02: Accelerated approval 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 withdrawn at request of manufacturer ''(Based on Hallmarq)'' | ||
| + | |||
| + | ==Also known as== | ||
| + | *'''Generic names:''' vincristine sulfate liposome injection, VSLI | ||
| + | *'''Brand name:''' Marqibo | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| + | |||
| + | [[Category:Drugs]] | ||
| + | [[Category:Intravenous medications]] | ||
| + | [[Category:Irritant]] | ||
| + | [[Category:Vesicant]] | ||
| + | [[Category:Liposomal chemotherapy]] | ||
| + | |||
| + | [[Category:Microtubule inhibitors]] | ||
| + | [[Category:Vinca alkaloids]] | ||
| + | |||
| + | [[Category:B-cell acute lymphoblastic leukemia medications (historic)]] | ||
| + | [[Category:Diffuse large B-cell lymphoma medications (historic)]] | ||
| + | |||
| + | [[Category:FDA approved in 2012]] | ||
| + | |||
| + | [[Category:Discontinued drugs]] | ||
| + | [[Category:FDA withdrawn in 2022]] | ||
Latest revision as of 00:15, 6 July 2024
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, or the prescribing information.[1]
Diseases for which it was used
Patient drug information
- Brief patient counseling information is available in the Vincristine liposomal (Marqibo) package insert.[1]
- Vincristine liposomal (Marqibo) patient drug information (Chemocare)[5]
History of changes in FDA indication
- 2012-08-09: Accelerated approval 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. (Based on RALLY)
- 2022-05-02: Accelerated approval 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 withdrawn at request of manufacturer (Based on Hallmarq)
Also known as
- Generic names: vincristine sulfate liposome injection, VSLI
- Brand name: Marqibo
References
- ↑ 1.0 1.1 1.2 Vincristine liposomal (Marqibo) package insert
- ↑ Vincristine liposomal (Marqibo) package insert (locally hosted backup)
- ↑ Marqibo manufacturer's website
- ↑ 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 liposomal (Marqibo) patient drug information (Chemocare)