Difference between revisions of "Irinotecan liposome (Onivyde)"
m |
m |
||
| Line 17: | Line 17: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*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. ''(Based on NAPOLI-1)'' | *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. ''(Based on NAPOLI-1)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *10/14/2016: Initial authorization | ||
==Also known as== | ==Also known as== | ||
*'''Code names:''' MM-398, MM398, PEP-02, PEP02 | *'''Code names:''' MM-398, MM398, PEP-02, PEP02 | ||
| − | *'''Brand name:''' Onivyde | + | *'''Brand name:''' Onivyde, Onivyde pegylated liposomal |
==References== | ==References== | ||
| Line 35: | Line 36: | ||
[[Category:Pancreatic cancer medications]] | [[Category:Pancreatic cancer medications]] | ||
[[Category:FDA approved in 2015]] | [[Category:FDA approved in 2015]] | ||
| + | [[Category:EMA approved in 2016]] | ||
Revision as of 12:30, 31 December 2022
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]
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
- 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. (Based on NAPOLI-1)
History of changes in EMA indication
- 10/14/2016: Initial authorization
Also known as
- Code names: MM-398, MM398, PEP-02, PEP02
- Brand name: Onivyde, Onivyde pegylated liposomal