Irinotecan Liposome (eye-ri-noe-TEE-kan LYE-poh-some)

Treats cancer of the pancreas.

Brand Name(s):

Onivyde

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the IV will need to stay in place for at least 90 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor may give you other medicines (including steroid medicine, medicine to prevent nausea and vomiting) 30 minutes before receiving this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how irinotecan liposome works. Tell your doctor if you are using atazanavir, carbamazepine, clarithromycin, gemfibrozil, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, ritonavir, saquinavir, St John's wort, telaprevir, or voriconazole.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Female patients should use effective birth control during treatment and for 7 months after the last dose. Male patients who have female partners should use effective birth control (including condoms) during treatment and for 4 months after the last dose.
• Do not breastfeed during treatment and for 1 month after the last dose.
• Tell your doctor if you have kidney disease, liver disease, or lung disease.
• This medicine may cause the following problems:
  • Severe diarrhea which can be life-threatening
  • Serious lung or breathing problems, including interstitial lung disease
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, cough
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Fever, chills, sore throat, body aches
• Severe or ongoing diarrhea, bloody or black, tarry stools

If you notice these less serious side effects, talk with your doctor:

• Constipation, stomach pain
• Decreased appetite
• Sores or white patches on your lips, mouth, or throat
• Tiredness or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088