What is ONIVYDE® (irinotecan liposome injection)?
ONIVYDE® is a prescription medicine used to treat pancreatic cancer which has spread to other parts of the body. ONIVYDE® is given in combination with 2 other medicines, fluorouracil (also known as 5-FU) and leucovorin (which is often abbreviated as LV), and is not given alone.
ONIVYDE® contains a chemotherapy drug called irinotecan, which in its active form interrupts cell reproduction. Irinotecan can be built into a container called a liposome. These liposomes are designed to release the medicine slowly over time.
In the clinical trial that led to FDA approval, ONIVYDE® was studied in combination with 2 other drugs called fluorouracil and leucovorin. This combination is referred to as ONIVYDE® + 5-FU/LV.
How ONIVYDE® was studied
Your doctor may recommend ONIVYDE® to treat your metastatic pancreatic cancer. The effectiveness of ONIVYDE® + 5-FU/LV was demonstrated in a clinical trial. Patients were split into 3 groups receiving ONIVYDE® + 5-FU/LV, 5-FU/LV alone, or ONIVYDE® alone.
In this trial, ONIVYDE® + 5-FU/LV demonstrated an improvement in median overall survival (OS). An improvement in median OS means patients receiving ONIVYDE® + 5-FU/LV had a greater chance of living longer when compared with the 5-FU/LV alone group (6.1 months [4.8–8.5] median OS vs 4.2 months [3.3–5.3]).
ONIVYDE® may not work for every patient. Individual results may vary.
The OS data from this study supported the approval of ONIVYDE® + 5-FU/LV for use in patients with metastatic pancreatic cancer whose disease has progressed following treatment with gemcitabine or gemcitabine in combination with another therapy. ONIVYDE® is not approved for use as a single drug without 5-FU/LV.
Selected Safety Information
The most common side effects which were seen in people with pancreatic cancer treated with ONIVYDE include: diarrhea, feeling tired, vomiting, nausea, loss of appetite, inflammation in the mouth, fever, and dehydration. When taking ONIVYDE, you may also have abnormal blood test results. The most common blood cell count change seen in ONIVYDE-treated pancreatic cancer patients is a reduction in the number of white blood cells, specifically lower lymphocytes and neutrophils (types of white blood cells), which are important for fighting infections.
The most common serious side effects of ONIVYDE were diarrhea, vomiting, fever and infection associated with low white blood cell count (also known as neutropenic fever or neutropenic sepsis), nausea, fever, sepsis (a complication of an infection), dehydration, septic shock (a severe complication of infection in which blood pressure drops dramatically), pneumonia, acute renal failure, and thrombocytopenia (also known as a low platelet count).
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