Difference between revisions of "Irinotecan liposome (Onivyde)"
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==Patient drug information== | ==Patient drug information== | ||
*No information available | *No information available | ||
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| + | ==History of changes in FDA indication== | ||
| + | *10/22/2015: Initial approval "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== | ||
Revision as of 22:29, 22 October 2015
General information
Class/mechanism: Topoisomerase I inhibitor with irinotecan contained within a liposomal sphere. The liposomal formulation increases the duration of the drug and volume of distribution in the body.[1][2][3]
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.
Diseases for which it is used
- Being investigated for use in Pancreatic cancer
Clinical trials
Patient drug information
- No information available
History of changes in FDA indication
- 10/22/2015: Initial approval "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
- ↑ 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