Onivyde® is the commercial brand name of Irinotecan Hydrochloride Liposome Injection, a liposomal formulation of irinotecan. It inhibits topoisomerase I to interfere with tumour DNA replication and transcription.
Main Indications
In combination with 5-fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have progressed following gemcitabine-based chemotherapy.
Clinical Research
The pivotal global Phase III trial demonstrated that Onivyde plus 5-FU/LV significantly improved overall survival compared with 5-FU/LV alone. Liposomal encapsulation increases drug concentration within tumour tissue and extends circulation time. The treatment-related adverse events were predictable and manageable.
Common Side Effects
Diarrhoea, neutropenia, fatigue, nausea;
Other common reactions: vomiting, decreased appetite, anaemia. Rare serious adverse events include febrile neutropenia, severe myelosuppression and sepsis.
Approval Status in China
Original drug Onivyde® (Irinotecan Hydrochloride Liposome Injection) was officially approved for marketing in China in April 2022, with the specification of 10ml:43mg. It is currently a prescription drug.
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