Onivyde is used to treat pancreatic cancer that has spread to other parts of the body (metastatic). This medicine is usually given in combination with other cancer medicines.

Onivyde may also be used for purposes not listed in this medication guide.

Onivyde can cause severe diarrhea, which can be life-threatening. Call your doctor whenever you have diarrhea during your treatment with Onivyde.

Onivyde is given as an infusion into a vein. A healthcare provider will give you this injection.

Onivyde must be given slowly, and the infusion can take up to 90 minutes to complete.

Onivyde can cause severe diarrhea, which can be life-threatening if it leads to dehydration.

Your doctor may recommend keeping anti-diarrhea medicine on hand at all times (such as loperamide or Imodium). Take this medicine at the first sign of loose or frequent bowel movements. Do not take loperamide for longer than 2 full days without your doctor's advice.

Call your doctor whenever you have diarrhea during your treatment with Onivyde.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

You should not use this medicine if you are allergic to irinotecan.

Tell your doctor if you have ever had:

• liver or kidney disease;

• lung disease; or

• an intestinal disorder or obstruction.

Onivyde can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.

• If you are a man, use condoms if your sex partner is able to get pregnant. Keep using condoms for at least 4 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Onivyde.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Call your doctor for instructions if you miss an appointment for your Onivyde.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how Onivyde will affect you. Your reactions could be impaired.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have signs of an allergic reaction: hives; chest tightness, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Onivyde may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing vomiting or diarrhea;

• black or bloody stools;

• sores or white patches in or around your mouth;

• new or worsening cough or shortness of breath;

• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• low blood cell counts--fever, tiredness, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed; or

• symptoms of sepsis--confusion, fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill.

Common side effects of Onivyde may include:

• fever, mouth sores, or other signs of infection;

• diarrhea;

• nausea, vomiting, loss of appetite; or

• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect Onivyde. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.