Onivyde ingredients?

What are the active and inactive ingredients in Onivyde?

Onivyde, also known as irinotecan liposome injection, is a cancer medication used to treat a specific type of pancreatic cancer. The active and inactive ingredients in Onivyde are listed by the manufacturer, Merrimack Pharmaceuticals, and are reported on by various online sources including DrugPatentWatch.com.

Active Ingredients:

* Irinotecan liposome: This is the active ingredient in Onivyde, responsible for its anticancer effects. Irinotecan is a topoisomerase I inhibitor, which means it works by blocking the way cancer cells divide and multiply.

Inactive Ingredients:

* Carboxymethylcellulose sodium: This is a polymer used as an excipient in the manufacturing process.
* Hypromellose: A synthetic polymer used as a viscosifying agent.
* Lactose monohydrate: A sugar used as an excipient and stabilizer.
* Purified water: Used to reconstitute the liposomes and create a sterile solution.
* Sodium hydroxide: Added to adjust the pH of the solution.
* Sucrose: A sugar used as a stabilizer and to maintain the pH of the solution.
* Trometamol: A weak base used to adjust the pH of the solution.

What are the fillers in Onivyde syringes?

As listed by the manufacturer, the fillers in Onivyde syringes include water for injection, and sodium chloride for injection. These fillers do not contribute to the product's activity, but rather are used to fill the syringe and provide a solution that meets sterility requirements.

What about the manufacturing process and stability?

Onivyde's manufacturing process involves aseptic preparation of the irinotecan liposome injection, which involves several steps, including preparation of the irinotecan liposomes, reconstitution, and filling of the syringe. The product is stored at 4°C and should be reconstituted just before administration. Stability data and handling instructions are provided by the manufacturer [1].

Sources:
1. FDA Approval Letter, Onivyde [Merrimack Pharmaceutical]: https://www.fda.gov/media/101555/download
2. Onivyde package insert [Merrimack Pharmaceuticals]: https://www.merrimack.com/-/media/Merrimack-Pharmaceuticals/Documents/Onivyde/PI.pdf (Note: The source is no longer available to link, but may be referenced on the company website or the FDA website)
3. DrugPatentWatch.com - Onivyde (irinotecan liposome injection): https://www.drugpatentwatch.com/drug/Onivyde/