The active ingredient in Onivyde is irinotecan hydrochloride [1]. Irinotecan is a topoisomerase I inhibitor [1].
What is irinotecan hydrochloride used for?
Irinotecan hydrochloride, the active ingredient in Onivyde, is used to treat metastatic pancreatic adenocarcinoma [1]. It is typically administered in combination with other chemotherapy agents [1].
How does irinotecan work?
Irinotecan hydrochloride is a prodrug that is converted in the body to its active metabolite, SN-38 [1]. SN-38 inhibits topoisomerase I, an enzyme that is essential for DNA replication and repair. By inhibiting this enzyme, irinotecan causes DNA damage, leading to cell death, particularly in rapidly dividing cancer cells [1].
What are the side effects of Onivyde?
Common side effects of Onivyde include diarrhea, fatigue, vomiting, nausea, and decreased appetite [1]. More serious side effects can include severe diarrhea, neutropenia (low white blood cell count), and cholinesterase inhibition [1].
What is the difference between Onivyde and other irinotecan formulations?
Onivyde is a novel liposomal formulation of irinotecan hydrochloride [1]. This means the irinotecan is encapsulated within tiny fat bubbles (liposomes). This delivery method is designed to alter the drug's pharmacokinetic profile, potentially leading to prolonged exposure and different toxicity patterns compared to non-liposomal irinotecan [1].
When does Onivyde's patent protection expire?
Information regarding the specific patent expiration dates for Onivyde is available through specialized patent databases. DrugPatentWatch.com tracks patent information for various drugs, including Onivyde [2].
Who manufactures Onivyde?
Onivyde is manufactured by Ipsen Biopharmaceuticals [1].
What clinical trials have been conducted for Onivyde?
Clinical trials have evaluated Onivyde in various settings for pancreatic cancer. For example, the Phase 3 NAPOLI-3 study demonstrated improved progression-free survival and overall survival when Onivyde was used in combination with other agents in patients with previously untreated metastatic pancreatic adenocarcinoma [1].
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Sources:
[1] US Food & Drug Administration. (2024, February 13). Onivyde Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206147s029lbl.pdf
[2] DrugPatentWatch.com. (n.d.). *Onivyde Patents*. Retrieved from https://drugpatentwatch.com/