Difference between revisions of "Irinotecan liposome (Onivyde)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Topoisomerase I inhibitor with irinotecan contained within a liposomal sphere. | + | Class/mechanism: Topoisomerase I inhibitor with [[Irinotecan (Camptosar)|irinotecan]] contained within a liposomal sphere. Irinotecan interferes with topoisomerase I's normal action of relieving torsional strain in DNA by creating reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I & DNA complex and interfere with ligation of these single-strand breaks. Failure to repair these breaks eventually leads to double-strand DNA damage, which disrupts cell proliferation and leads to cell death. In mouse models, 5 times lower doses of liposomal irinotecan were able to achieve similar intratumoral exposure levels of SN-38 as compared to irinotecan HCl.<ref name="insert">[https://www.onivyde.com/_assets/pdf/ONIVYDE_USPI.pdf Irinotecan liposome (Onivyde) package insert]</ref><ref>[[Media:Irinotecanliposomal.pdf | Irinotecan liposome (Onivyde) package insert (locally hosted backup)]]</ref><ref>[https://www.onivyde.com/ Onivyde manufacturer's website]</ref><ref>Roy AC, Park SR, Cunningham D, Kang YK, Chao Y, Chen LT, Rees C, Lim HY, Tabernero J, Ramos FJ, Kujundzic M, Cardic MB, Yeh CG, de Gramont A. A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma. Ann Oncol. 2013 Jun;24(6):1567-73. [http://annonc.oxfordjournals.org/content/24/6/1567.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/23406728 PubMed]</ref><ref>Ko AH, Tempero MA, Shan YS, Su WC, Lin YL, Dito E, Ong A, Wang YW, Yeh CG, Chen LT. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br J Cancer. 2013 Aug 20;109(4):920-5. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3749576/ link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/23880820 PubMed]</ref><ref>[http://merrimackpharma.com/solutions/pipeline/mm-398 Merrimack Pharmaceuticals's MM-398 website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information available | <br>Extravasation: no information available | ||
| − | 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== | ==Diseases for which it is used== | ||
| − | * | + | *[[Pancreatic cancer]] |
==Clinical trials== | ==Clinical trials== | ||
| Line 13: | Line 13: | ||
==Patient drug information== | ==Patient drug information== | ||
| − | * | + | *Patient counseling information is available in the [https://www.onivyde.com/_assets/pdf/ONIVYDE_USPI.pdf Irinotecan liposome (Onivyde) package insert]<ref name="insert"></ref> |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *10/22/2015: | + | *10/22/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm468728.htm FDA approved] "in combination with [[Fluorouracil (5-FU)|fluorouracil (5FU)]] and [[Folinic acid (Leucovorin)|leucovorin (LV)]], for the treatment of patients with metastatic [[Pancreatic cancer|adenocarcinoma of the pancreas]] whose disease has progressed following [[Gemcitabine (Gemzar)|gemcitabine]]-based therapy." |
==Also known as== | ==Also known as== | ||
| Line 29: | Line 29: | ||
[[Category:Topoisomerase inhibitors]] | [[Category:Topoisomerase inhibitors]] | ||
| − | + | [[Category:Pancreatic cancer medications]] | |
| − | [[Category: | + | [[Category:Drugs FDA approved in 2015]] |
Revision as of 01:00, 23 October 2015
General information
Class/mechanism: Topoisomerase I inhibitor with irinotecan contained within a liposomal sphere. Irinotecan interferes with topoisomerase I's normal action of relieving torsional strain in DNA by creating reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I & DNA complex and interfere with ligation of these single-strand breaks. Failure to repair these breaks eventually leads to double-strand DNA damage, which disrupts cell proliferation and leads to cell death. In mouse models, 5 times lower doses of liposomal irinotecan were able to achieve similar intratumoral exposure levels of SN-38 as compared to irinotecan HCl.[1][2][3][4][5][6]
Route: IV
Extravasation: no information available
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
- Patient counseling information is available in the Irinotecan liposome (Onivyde) package insert[1]
History of changes in FDA indication
- 10/22/2015: FDA approved "in combination with fluorouracil (5FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy."
Also known as
MM-398, MM398, PEP-02, PEP02.
References
- ↑ 1.0 1.1 1.2 Irinotecan liposome (Onivyde) package insert
- ↑ Irinotecan liposome (Onivyde) package insert (locally hosted backup)
- ↑ Onivyde manufacturer's website
- ↑ Roy AC, Park SR, Cunningham D, Kang YK, Chao Y, Chen LT, Rees C, Lim HY, Tabernero J, Ramos FJ, Kujundzic M, Cardic MB, Yeh CG, de Gramont A. A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma. Ann Oncol. 2013 Jun;24(6):1567-73. link to original article contains protocol PubMed
- ↑ Ko AH, Tempero MA, Shan YS, Su WC, Lin YL, Dito E, Ong A, Wang YW, Yeh CG, Chen LT. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br J Cancer. 2013 Aug 20;109(4):920-5. link to original article contains protocol PubMed
- ↑ Merrimack Pharmaceuticals's MM-398 website