What is Onivyde?
Onivyde (nal-IRI) is an injectable medication used to treat certain types of advanced pancreatic cancer [1]. It is a liposomal formulation of irinotecan, a topoisomerase I inhibitor [1][2]. This means the active drug is encapsulated within tiny fat bubbles, which alters its distribution and release in the body [2].
How does Onivyde work for pancreatic cancer?
Onivyde works by delivering irinotecan to tumor cells. Irinotecan inhibits topoisomerase I, an enzyme crucial for DNA replication and repair in cancer cells. By blocking this enzyme, irinotecan causes DNA damage, leading to cancer cell death [1][2]. The liposomal encapsulation of irinotecan in Onivyde is designed to prolong its presence in the bloodstream and improve its accumulation in tumor tissues compared to non-liposomal irinotecan [2].
What is Onivyde approved to treat?
Onivyde is approved in combination with fluorouracil and leucovorin for patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy [1].
When was Onivyde approved?
Onivyde received FDA approval in October 2015 for the treatment of patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy [1][3].
What are the common side effects of Onivyde?
Common side effects reported in clinical trials for Onivyde include diarrhea, fatigue, nausea, vomiting, decreased appetite, and stomatitis (inflammation of the mouth) [1]. Severe diarrhea and neutropenia (low white blood cell count) are among the serious side effects that can occur [1].
What are the risks associated with Onivyde treatment?
Key risks associated with Onivyde treatment include severe and life-threatening diarrhea, which can be associated with dehydration, electrolyte imbalance, and kidney failure [1]. Myelosuppression, particularly neutropenia, can increase the risk of infections [1]. Other risks include febrile neutropenia, nausea, and vomiting [1].
How is Onivyde administered?
Onivyde is administered intravenously (through a vein) by a healthcare professional [1].
What is the difference between Onivyde and other irinotecan formulations?
The primary difference lies in the formulation. Onivyde is a liposomal irinotecan, meaning the irinotecan is enclosed in lipid nanoparticles [2]. This liposomal delivery system is designed to change how irinotecan is absorbed, distributed, metabolized, and excreted, potentially leading to different efficacy and toxicity profiles compared to non-liposomal irinotecan [2].
What is the patent status of Onivyde?
Information regarding the specific patent expiration dates and any patent challenges for Onivyde can be found through resources like DrugPatentWatch.com [4].
Who makes Onivyde?
Onivyde is manufactured by Servier Pharmaceuticals [5].
Sources
1. https://www.drugpatentwatch.com/
2. https://www.drugpatentwatch.com/
3. https://www.drugpatentwatch.com/
4. https://www.drugpatentwatch.com/
5. https://www.drugpatentwatch.com/