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Irinotecan Liposome (Injection) (Injectable)

(ONIVYDE)
Irinotecan Liposome (By injection)
Irinotecan Liposome (eye-ri-noe-TEE-kan LYE-poh-some)Treats cancer of the pancreas.
Onivyde

When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to irinotecan liposome or irinotecan, or if you are pregnant.

How to Use This Medicine:
Injectable

  • 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.
  • Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
  • 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.
  • Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

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

  • Tell your doctor if you are using a medicine that contains irinotecan.
  • Some foods and medicines can affect how irinotecan liposome works. Tell your doctor if you are using any of the following:
    • Atazanavir, carbamazepine, clarithromycin, gemfibrozil, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, ritonavir, saquinavir, St John's wort, telaprevir, 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. Use an effective form of birth control during therapy and for 1 month after the last dose of this medicine. Men who are receiving irinotecan liposome should use condoms as a form of birth control during treatment and for 4 months after your final dose.
  • Do not breastfeed during treatment and for 1 month after the last dose of this medicine.
  • Tell your doctor if you have bowel blockage or lung disease.
  • This medicine may cause the following problems:
    • Severely low levels of white blood cells, which may lead to serious and life-threatening infection
    • Diarrhea that could be severe and life-threatening
    • Interstitial lung disease
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
  • 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.

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
  • Fever, chills, trouble breathing, cough, sore throat, and body aches
  • Severe or ongoing diarrhea, bloody or black, tarry stools

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

  • Decreased appetite, nausea, vomiting
  • 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