Indication and Important Safety Information about ONIVYDE® (irinotecan liposome injection)
What is ONIVYDE used for?
ONIVYDE is a prescription medicine used to treat pancreatic cancer which has spread to other parts of the body. ONIVYDE can be used in patients who have already received gemcitabine treatment for their pancreatic cancer. 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.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ONIVYDE?
ONIVYDE can cause problems that can sometimes become serious or life threatening and can lead to death. Serious side effects may include fever and infection associated with a low white blood count (severe neutropenic fever or neutropenic sepsis) and severe diarrhea.
Call your doctor or get medical help right away if you experience these problems after treatment with ONIVYDE.
Before receiving ONIVYDE, tell your healthcare provider if you:
- have had a severe allergic reaction to ONIVYDE or irinotecan HCl,
- have a problem in your bowel that prevents food, fluids or gas from moving through your intestines,
- are pregnant or planning to become pregnant. Females who are able to become pregnant should use effective birth control (contraception) during treatment with ONIVYDE and for 7 months following the last dose of ONIVYDE due to potential risk to the fetus,
- are a man, you should not father a child during your treatment with ONIVYDE. ONIVYDE can harm the unborn baby of your partner. You should use an effective method of birth control during and for at least 4 months after the last dose of ONIVYDE,
- are breastfeeding or plan to breastfeed. Patients should not breastfeed during treatment with ONIVYDE and for 1 month after the last dose.
What are possible side effects of ONIVYDE?
ONIVYDE can cause serious side effects, including:
- Infections (particularly if your white blood cells are low). Symptoms of infection may include fever, chills, dizziness, or shortness of breath. Blood cell counts will be monitored periodically by your healthcare provider during treatment.
- Diarrhea. Symptoms of severe diarrhea may include persistent diarrhea; discolored stools (black, green or bloody); or symptoms of dehydration such as lightheadedness, dizziness, or faintness. Your healthcare provider may treat diarrhea with anti-diarrhea medicines (loperamide or atropine).
- Lung problems (interstitial lung disease). Symptoms of interstitial lung disease include new onset of cough or difficulty breathing and fever.
- Allergic reaction (hypersensitivity). Seek immediate medical attention for signs of severe reaction such as chest tightness; shortness of breath; wheezing; dizziness or faintness; or swelling of the face, eyelids, or lips when receiving or during the 24 hours after receiving ONIVYDE.
Your healthcare provider will check you for these problems during treatment with ONIVYDE. Your healthcare provider may also need to delay or completely stop treatment with ONIVYDE, if you have severe side effects.
What are the most common side effects of ONIVYDE?
- 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.
- The most frequent side effects resulting in discontinuation of ONIVYDE were diarrhea, vomiting, and infection caused by low white blood cells (neutropenic sepsis).
- The most frequent side effects requiring dose reductions of ONIVYDE were neutropenia, diarrhea, nausea, and low red blood cell count (anemia).
- The most frequent side effects requiring dose interruptions or delays of ONIVYDE were neutropenia, diarrhea, fatigue, vomiting, and low platelet counts called thrombocytopenia (platelets are important for clotting to stop bleeding).
Tell your healthcare provider about all the medicines you take, including:
- prescriptions
- over-the-counter medicines
- vitamins
- herbal supplements
These are not all the possible side effects of ONIVYDE.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. To learn more, talk to your healthcare provider. You can ask your doctor or pharmacist for information about ONIVYDE that is written for health professionals, and it can be found at ONIVYDE.com.
If you think you or someone you know has experienced an adverse event related to an Ipsen product or has a product complaint, please contact Ipsen Biopharmaceuticals, Inc., at 1-855-463-5127. You are encouraged to report side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
