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 or you are pregnant.

How to Use This Medicine:
Injectable

• 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 will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine is given slowly, so the needle will remain in place for about 90 minutes.
• 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.

• Some medicines can affect how irinotecan works. You may also need to stop taking certain medicines before you start taking irinotecan. Tell your doctor if you are using any of the following:
  
  • Gemfibrozil, nefazodone, St John's wort
  • Medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, rifabutin, rifampin, voriconazole)
  • Medicine to treat HIV infection (such as atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir)
  • Medicine to treat seizures (such as carbamazepine, phenytoin, phenobarbital)

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, Gilbert syndrome, lung problems, bone marrow disease, any type of infection, or an enzyme problem called reduced UGT1A1 activity.
• 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 cause the following problems:
  
  • Kidney problems
  • Lung problems
• This medicine often causes diarrhea. Diarrhea can begin while you are receiving a dose of medicine or shortly afterward, or it may occur more than 24 hours later. Your doctor may give you medicine to treat diarrhea. Follow instructions carefully.
• This medicine may make you dizzy or cause vision problems. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• 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
• Decrease in how much or how often you urinate, bloody urine, lower back or side pain
• Fever, chills, cough, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Runny nose, watery eyes, flushing, slow heartbeat
• Severe diarrhea, stomach pain or cramping, red or black stools
• Severe nausea or vomiting
• Swelling in your hands, ankles, or feet
• Trouble breathing, fever, or cough
• Unusual bleeding, bruising, or weakness
• Yellow skin or eyes

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

• Constipation, upset stomach, loss of appetite, weight loss
• Hair loss
• Redness, pain, or swelling where the needle is placed

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