Difference between revisions of "Irinotecan liposome (Onivyde)"

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==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Pancreatic cancer]]  
 
*[[Pancreatic cancer]]  
 
==Clinical trials==
 
*NAPOLI 1: [https://clinicaltrials.gov/ct2/show/NCT01494506 Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer (NAPOLI 1)]
 
  
 
==Patient drug information==
 
==Patient drug information==
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==Also known as==
 
==Also known as==
MM-398, MM398, PEP-02, PEP02.
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*'''Code names:''' MM-398, MM398, PEP-02, PEP02
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*'''Brand name:''' Onivyde
  
 
==References==
 
==References==
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[[Category:Drug index]]
 
[[Category:Drug index]]
[[Category:Chemotherapy]]
 
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
 +
[[Category:Liposomal chemotherapy]]
  
 
[[Category:Topoisomerase inhibitors]]
 
[[Category:Topoisomerase inhibitors]]
 
[[Category:Pancreatic cancer medications]]  
 
[[Category:Pancreatic cancer medications]]  
 
[[Category:Drugs FDA approved in 2015]]
 
[[Category:Drugs FDA approved in 2015]]

Revision as of 03:08, 27 October 2017

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

Patient drug information

History of changes in FDA indication

Also known as

  • Code names: MM-398, MM398, PEP-02, PEP02
  • Brand name: Onivyde

References

  1. 1.0 1.1 1.2 Irinotecan liposome (Onivyde) package insert
  2. Irinotecan liposome (Onivyde) package insert (locally hosted backup)
  3. Onivyde manufacturer's website
  4. 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
  5. 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
  6. Merrimack Pharmaceuticals's MM-398 website