Irinotecan liposome (Onivyde)
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
- 2015-10-22: 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)
- 2024-02-13: Approved with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma. (Based on NAPOLI 3)
History of changes in EMA indication
- 2016-10-14: Initial authorization
History of changes in Health Canada indication
- 2017-08-09: Initial notice of compliance (unclear details)
History of changes in PMDA indication
- 2020-03-25: Newly indicated for the treatment of unresectable pancreatic cancer that has progressed after cancer chemotherapy.
Also known as
- Code names: MM-398, PEP-02
- Brand name: Onivyde, Onivyde pegylated liposomal