Irinotecan Intravenous

In the U.S.

• Camptosar
• Novaplus Irinotecan Hydrochloride

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Topoisomerase I Inhibitor

Irinotecan injection is given together with other medicines to treat patients with metastatic cancer (a cancer that has already spread) of the colon or rectum.

Irinotecan belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may occur after treatment with irinotecan has been stopped. Be sure that you have discussed with your doctor the possible side effects of irinotecan as well as the good it can do.

irinotecan is available only with your doctor's prescription.

A doctor or other trained health professional will give you irinotecan in a hospital or cancer treatment center. irinotecan is given through a needle placed in one of your veins.

Irinotecan often causes nausea and vomiting. However, it is very important that you continue to receive irinotecan even if you begin to feel ill. You may receive other medicines to help with the nausea and vomiting. Ask your doctor for other ways to lessen these effects.

It is very important that your doctor check your progress at regular visits to make sure that irinotecan is working properly. Blood tests may be needed to check for unwanted effects.

Make sure your doctor knows if you are pregnant before you receive irinotecan. Using irinotecan while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

irinotecan may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have chills; fever; hives; hoarseness; itching; rash; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

While you are being treated with irinotecan, and after you stop treatment, do not have any immunizations (vaccinations) without your doctor's approval. Irinotecan may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not get live vaccines (e.g., nasal influenza or flu vaccine). Try to avoid persons who have taken live vaccines. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should wear a protective face mask that covers the nose and mouth.

Irinotecan may cause diarrhea, which can last long enough and be severe enough to cause serious medical problems. If diarrhea occurs while you are being treated with irinotecan:

• Check with your doctor immediately. Be sure to let your doctor know if the diarrhea started during an irinotecan injection or less than 24 hours afterwards. Also, be sure to tell your doctor if you had any other symptoms, such as stomach cramps or sweating, before the diarrhea started. This means that you are having a certain kind of diarrhea that may need to be treated by your doctor.
• If diarrhea first occurs more than 24 hours after a dose of irinotecan, start taking loperamide (Imodium A-D®) as soon as you notice that your bowel movements are occurring more often or are more loose than usual. Loperamide is available without a prescription. Buy some of it ahead of time, so that you will have it on hand in case it is needed. Unless otherwise directed by your doctor, take 4 milligrams (mg) of loperamide (2 capsules or tablets, or 4 teaspoonfuls of the oral solution dosage form) for the first dose, then 2 mg (1 capsule or tablet, or 2 teaspoonfuls of the oral solution dosage form) every two hours. To interrupt your sleep less often, you may take 4 mg of loperamide every four hours during the night. Continue taking loperamide, day and night, until you have not had any diarrhea for twelve hours. It is very important that you follow these (or your doctor's) directions, even though they are different from the directions on the nonprescription (over-the-counter [OTC]) loperamide package label. The largest amount of loperamide recommended on the package label for use in a twenty-four-hour period (8 mg) is not enough for treating diarrhea caused by irinotecan. Notify your doctor if the diarrhea is not controlled within 24 hours.
• Diarrhea causes loss of body fluid, which can lead to dehydration, a serious medical problem. To prevent this, it is very important that you replace the lost fluid. While you have diarrhea, and for a day or two after the diarrhea has stopped, drink plenty of clear liquids, such as ginger ale, caffeine-free cola, decaffeinated tea, and broth. Ask your doctor about the amount of liquid you should be drinking every day. Also, ask your doctor whether you should use a sports drink (e.g., Gatorade®), which contains other substances, such as sodium and potassium, that may be lost along with body fluid. Follow your doctor's directions very carefully.
• Because alcohol and caffeine can increase fluid loss, you should not drink beverages or take any medicines that contain them while you have diarrhea. Also, avoid eating foods that may make diarrhea worse, such as bran, raw fruits or vegetables, or fatty, fried, or spicy foods.
• Vomiting can also increase the amount of fluid lost by the body and increase the risk of dehydration. If vomiting occurs at the same time as diarrhea, check with your doctor right away.
• Signs of too much fluid loss (dehydration) include decreased urination, dizziness or light-headedness, dryness of the mouth, fainting, increased thirst, and wrinkled skin. If any of these occur, check with your doctor immediately.

Irinotecan can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are needed for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Also, check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Call your doctor right away if you have an unexplained fever, cough, shortness of breath, trouble with breathing, or wheezing after receiving irinotecan. These may be symptoms of a serious lung problem.

irinotecan may increase your risk of having blood clots. Tell your doctor right away if you start having a sudden and severe headache, trouble with breathing, or problems with vision, speech, or walking.

irinotecan may cause some people to become dizzy, drowsy, or less alert than they are normally. irinotecan may also cause blurred vision or other vision problems. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well. If these reactions are especially bothersome, check with your doctor.

Ketoconazole (Nizoral®) and St. John's wort should not be used while you are receiving irinotecan. If you are using St. John's Wort, it should be discontinued at least 2 weeks before the first cycle of irinotecan. If you are using ketoconazole, it should be discontinued at least 1 week before starting irinotecan treatment.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

See also Warning section.

Nausea, vomiting, loss of appetite, constipation, cough, drowsiness, mouth sores, weakness, or trouble sleeping may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, or if you are unable to drink/eat because of nausea/vomiting, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: pain/redness/swelling at the injection site or arms/legs, numbness/tingling/burning of arms/legs, black/bloody stools, signs of kidney problems (such as change in the amount of urine), lung problems (such as shortness of breath, cough).

Get medical help right away if you have any very serious side effects, including: chest pain, weakness on one side of the body, slurred speech, confusion, trouble breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Irinotecan can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.