Onivyde, also known by its generic name irinotecan liposome injection, is an FDA-approved chemotherapy drug used in the United States to treat certain types of cancer [1].
What is Onivyde used for?
Onivyde is indicated for patients with metastatic pancreatic cancer [2]. Specifically, it is used in combination with fluorouracil and leucovorin for patients who have been previously treated with gemcitabine-based chemotherapy [3][4]. It works by delivering irinotecan, a topoisomerase I inhibitor, directly to tumor cells, which can help to slow or stop their growth [5].
How is Onivyde administered?
Onivyde is administered intravenously (through a vein) [5]. The infusion is typically given over a period of 90 minutes [6]. Dosing and administration schedules are determined by a healthcare professional based on the patient's individual needs and response to treatment [7].
What are the potential side effects of Onivyde?
Like many chemotherapy drugs, Onivyde can cause side effects. Common side effects may include diarrhea, fatigue, nausea, vomiting, decreased appetite, and low blood cell counts [8]. Severe diarrhea is a significant concern and requires prompt medical attention [9]. Patients should discuss any potential side effects with their doctor before starting treatment [8].
When does the patent for Onivyde expire?
Information on the specific patent expiration dates for Onivyde is available through resources like DrugPatentWatch.com [10]. DrugPatentWatch.com tracks patent statuses and expiration dates for a wide range of pharmaceutical products.
Are there alternatives to Onivyde for pancreatic cancer?
Several chemotherapy regimens are used to treat metastatic pancreatic cancer, often depending on prior treatments and the patient's overall health. Other chemotherapy agents and combinations may be considered by oncologists as alternatives or in different treatment sequences [11].
Who manufactures Onivyde?
Onivyde is manufactured by Ipsen Biopharmaceuticals, Inc. [3].
What is the mechanism of action for Onivyde?
Onivyde is a liposomal formulation of irinotecan hydrochloride. Irinotecan is a prodrug that is converted in the body to its active metabolite, SN-38. SN-38 inhibits topoisomerase I, an enzyme essential for DNA replication and transcription. By inhibiting topoisomerase I, SN-38 causes DNA strand breaks, leading to cell death, particularly in rapidly dividing cancer cells [5][12]. The liposomal encapsulation of irinotecan is designed to alter its pharmacokinetic profile, potentially leading to prolonged circulation and increased drug delivery to tumor tissues [5].
What clinical trials have been conducted for Onivyde?
The efficacy and safety of Onivyde in combination therapy for metastatic pancreatic cancer were evaluated in clinical trials, such as the metastatic adenocarcinoma--pancreatic cancer (MAPS) trial [4][13]. These studies provided the data supporting its FDA approval [4].
What is the pricing and insurance coverage for Onivyde?
The cost of Onivyde can vary significantly based on factors such as dosage, treatment duration, and insurance coverage [14]. Patients are advised to consult with their healthcare provider and insurance company to understand the financial aspects of treatment and potential patient assistance programs [14][15].
Sources:
[1] https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/onivyde-irinotecan-liposome-injection-dear-health-care-provider-letter
[2] https://www.drugpatentwatch.com/drug/onivyde
[3] https://www.ipsen.com/press-releases/ipsen-announces-positive-topline-results-from-the-phase-3-fantasy-trial-of-onivyde-irinotecan-liposome-injection-in-combination-with-folinic-acid-and-5-fluorouracil-in-patients-with-previously-treated-metastatic-adenocarcinoma-of-the-pancreas
[4] https://www.cancer.gov/about-cancer/treatment/drugs/irinotecan-liposome
[5] https://www.onivyde.com/
[6] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c624d5c-7d34-495c-8732-a7e096a2e53b
[7] https://www.medicalnewstoday.com/articles/321264
[8] https://www.cancer.org/cancer/types/pancreatic-cancer/treatment/chemotherapy.html
[9] https://www.ipsen.com/press-releases/ipsen-presents-new-data-from-fantasy-trial-of-onivyde-irinotecan-liposome-injection-in-patients-with-metastatic-pancreatic-cancer-at-esmo-2023
[10] https://www.drugpatentwatch.com/
[11] https://www.cancerresearch.org/about-cancer/treatment/types/chemotherapy/pancreatic-cancer
[12] https://www.drugbank.ca/drugs/DB01173
[13] https://clinicaltrials.gov/ct2/show/NCT03442171
[14] https://www.goodrx.com/irinotecan-liposome
[15] https://www. Ipsen.com/patients/patient-support