Generic Name: irinotecan liposome injection
Trade Name: Onivyde™
For which conditions is this drug approved? Onivyde in combination with fluorouracil and leucovorin is indicated for the treatment of patients with metastatic pancreatic cancer whose cancer has progressed after gemcitabine-based therapy.
What is the mechanism of action? Onivyde is thought to work by blocking the action of an enzyme in cells called topoisomerase I. Cells need this enzyme to keep their DNA in the proper shape when they are dividing. Blocking this enzyme leads to breaks in the DNA, which leads to cell death. Because cancer cells divide faster than normal cells, they are more likely than normal cells to be affected by liposomal irinotecan. And because Onivyde is formulated as a nanoliposomal encapsulation of the drug irinotecan, it can stay in circulation in the body longer than standard irinotecan. This allows greater drug take-up within the tumor cells and converts it to its active form, SN38, which promotes cancer cell death.
How is Onivyde typically given (administered)? Onivyde is given as in infusion into a vein.
What are the most common side effects of treatment with Onivyde?
- Nausea and vomiting
- Decreased appetite
- Inflammation of the mouth
- Low white blood cell levels – increases the risk of infection
What are some of the more serious but less common side effects of Onivyde?
- Severe diarrhea
- Severe neutropenia (low counts of white blood cells)
- Severe interstitial lung disease
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What should patients be aware of after treatment with Onivyde? Patients should contact their healthcare provider immediately if any severe reaction should occur.
Are there any special precautions patients should be aware of before starting treatment?
- Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should avoid laxatives because these may make diarrhea worse.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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