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|Xeloda

CAPECITABINE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Xeloda

In Canada—

• Xeloda

Category

• Antineoplastic

Description

Capecitabine (ka-pe-SITE-a-been) belongs to the group of medicines called antimetabolites. It is used to treat breast cancer and colorectal cancer.

Capecitabine 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 will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For capecitabine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to capecitabine or to fluorouracil. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—It is best to avoid pregnancy during treatment with this medicine. Studies in animals have found that capecitabine causes birth defects and death of the fetus. Be sure that you have discussed this with your doctor before starting treatment with this medicine. Also, tell your doctor right away if you think you have become pregnant while taking this medicine.

Breast-feeding—It is not known whether capecitabine passes into human breast milk. However, because this medicine may cause serious side effects, breast-feeding generally is not recommended while you are taking it.

Children—There is no specific information comparing use of capecitabine in children with use in other age groups.

Older adults—Patients 80 years of age or older may be more sensitive to the effects of capecitabine. Severe diarrhea, nausea, or vomiting may be more likely to occur in these patients. Patients 60 years of age and older and/or who are also taking an anticoagulant (blood thinner), may be more likely to have blood clotting problems.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking capecitabine, it is especially important that your health care professional knows if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir)
• If you have ever been treated with radiation or cancer medicines—Capecitabine may increase the effects of these medicines or radiation therapy on the blood

• Anticoagulants, coumarin-type (blood thinners)—These medicines can cause increased risk of bleeding and alter blood clotting

• Vaccines, live virus—Extreme caution should be used. A live virus vaccine could cause the side effects of the vaccine to be worse or may cause the vaccine to not work as well.

Other medical problems—The presence of other medical problems may affect the use of capecitabine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to capecitabine or to any ingredients in this medicine or
• Allergy to 5-fluorouracil or
• Shortage of an enzyme called dihydropyrimidine dehydrogenase that your body needs—Capecitabine should not be used

• Bone marrow depression or
• Cancer—May increase risk of blood clotting problems

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body
• Heart disease—The risk of a side effect that affects the heart may be increased
• Kidney disease, moderate or severe—The risk of side effects that affect the kidneys may be increased. Capecitabine should not be used in patients with severe kidney disease.
• Liver disease—The amount of capecitabine in the body may be increased in patients with liver disease. Also, the risk of a side effect that affects the liver may be increased
• Infection—Capecitabine decreases your body"s ability to fight infection

Proper Use of This Medicine

Each dose of this medicine should be taken within 30 minutes after the end of a meal.

Swallow the tablets with water.

Dosing—The dose of capecitabine will be different for different patients. The dose that is used depends on a number of things, including the patient"s body size. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of capecitabine. If your dose is different, do not change it unless your doctor tells you to do so. If you have any questions about the proper dose of capecitabine, ask your doctor.

• For oral dosage form (tablets):
  • For breast cancer:
    • Adults—The starting dose is usually 2500 milligrams (mg) per square meter of body surface area a day, divided into two doses and taken about twelve hours apart within 30 minutes after the end of a meal. However, the dose may have to be decreased if certain side effects occur.
    • Children—Use and dose must be determined by your doctor.
  • In combination with docetaxel to treat breast cancer:
    • The starting dose of capecitabine is usually 2500 milligrams (mg) per square meter of body surface area a day, divided into two doses and taken about twelve hours apart within 30 minutes after the end of a meal combined with docetaxel at 75 mg per square meter of body surface area as a 1 hour infusion every 3 weeks.
    • Children—Use and dose must be determined by your doctor.
  • For colorectal cancer:
    • Adults—The starting dose is usually 2500 milligrams (mg) per square meter of body surface area a day, divided into two doses and taken about twelve hours apart within 30 minutes after the end of a meal. However, the dose may have to be decreased if certain side effects occur.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, do not take the missed dose at all and do not double the next one. Instead, go back to your regular dosing schedule and check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Your health care professional may request that you have a test to determine if your blood is clotting properly and may preform this test frequently, if you are also taking an anticoagulant (blood thinner).

Check with your doctor immediately if you develop a fever of 100.5 °F or higher, or if you notice any other signs of a possible infection. These signs include cough or hoarseness, lower back or side pain, painful or difficult urination, sneezing, sore throat, stuffy nose, and white spots inside the mouth or throat.

Stop taking this medicine and check with your doctor immediately if any of the following occur:

• Diarrhea, moderately severe (four to six stools a day more than usual, or during the night).
• Pain, blistering, peeling, redness, or swelling of the palms of your hands and/or the bottoms of your feet that is severe enough to interfere with your normal activities.
• Nausea that is severe enough to cause you to eat less than usual.
• Vomiting that occurs two times, or more, in a 24-hour period.
• Pain and redness, swelling, or sores or ulcers in your mouth or on your lips that are severe enough to interfere with eating.

If vomiting occurs less often than mentioned above, or if nausea does not cause you to eat less than usual, it is not necessary for you to stop taking the medicine or to check with your doctor (unless these effects are particularly bothersome). Also, you do not need to stop taking the medicine if diarrhea occurs less often than mentioned above or if the other side effects listed are not severe enough to interfere with eating or other daily activities. However, check with your doctor as soon as possible if they occur.

While you are being treated with capecitabine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor"s approval . Capecitabine 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 take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. 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 consider wearing a protective face mask that covers the nose and mouth.

Capecitabine 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 necessary 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 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. 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.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 08/14/1998
Revised: 08/11/2005

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