Uses of Irinotecan:

• It is used to treat colorectal cancer.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Irinotecan?

• If you have an allergy to irinotecan or any other part of irinotecan (conventional).
• If you are allergic to irinotecan (conventional); any part of irinotecan (conventional); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are on dialysis, talk with your doctor.
• If you take any other drugs (prescription or OTC, natural products, vitamins). There are many drugs that interact with irinotecan (conventional), like certain drugs that are used for HIV, infections, or seizures.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with irinotecan (conventional).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take irinotecan (conventional) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Irinotecan?

• Tell all of your health care providers that you take irinotecan (conventional). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how irinotecan (conventional) affects you.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Talk with your doctor before getting any vaccines. Use of some vaccines with irinotecan (conventional) may either raise the chance of an infection or make the vaccine not work as well.
• This medicine may irritate the vein. If the drug leaks from the vein, it may also cause irritation around that area. Tell your nurse if you have any redness, burning, pain, swelling, or leaking of fluid where the drug is going into your body.
• Blood clots have happened with irinotecan (conventional). Tell your doctor if you have ever had a blood clot. Talk with your doctor.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
• If you are 65 or older, use irinotecan (conventional) with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking irinotecan (conventional).
• If you are pregnant or you get pregnant while taking irinotecan (conventional), call your doctor right away.

How is this medicine (Irinotecan) best taken?

Use irinotecan (conventional) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Other drugs may be given before irinotecan (conventional) to help avoid side effects.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Feeling very tired or weak.
• Very bad dizziness or passing out.
• Redness or irritation of the palms of hands or soles of feet.
• Some people have had lung problems with irinotecan (conventional). Sometimes, this has been deadly. Call your doctor right away if you have signs of lung problems like shortness of breath or other trouble breathing, cough that is new or worse, or fever.

What are some other side effects of Irinotecan?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hair loss.
• Upset stomach or throwing up.
• Dizziness.
• Trouble sleeping.
• Headache.
• Mouth irritation or mouth sores.
• Belly pain.
• Not hungry.
• Constipation.
• Feeling tired or weak.
• Back pain.
• Sweating a lot.
• Weight loss.
• Gas.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Irinotecan?

• If you need to store irinotecan (conventional) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about irinotecan (conventional), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.