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 eventuallydestroyed. 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 reportedto your doctor. Other effects may not be serious but may cause concern.

This medicine is available only with your doctor's prescription, in thefollowing 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 willdo. This is a decision you and your doctor will make. For capecitabine, thefollowing should be considered:

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

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

Breast-feeding?It is not known whether capecitabine passes intohuman 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 ofcapecitabine in children with use in other age groups.

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingcapecitabine, it is especially important that your health care professionalknows 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?Capecitabinemay increase the effects of these medicines or radiation therapy on the blood

• Anticoagulants, coumarin-type (blood thinners)?These medicinescan cause increased risk of bleeding and alter blood clotting

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

Other medical problems?The presence ofother medical problems may affect the use of capecitabine. Make sure you tellyour 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 thatyour 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 otherparts of the body
• Heart disease?The risk of a side effect that affects the heartmay be increased
• Kidney disease, moderate or severe?The risk of side effectsthat affect the kidneys may be increased. Capecitabine should not be usedin patients with severe kidney disease.
• Liver disease?The amount of capecitabine in the body may beincreased in patients with liver disease. Also, the risk of a side effectthat affects the liver may be increased
• Infection?Capecitabine decreases your body's ability to fightinfection

Proper Use of This Medicine

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

Swallow the tablets with water.

Dosing?The dose of capecitabine will be differentfor different patients. The dose that is used depends on a number of things,including the patient's body size. Follow your doctor'sorders or the directions on the label. The following information includesonly the average doses of capecitabine. If your doseis 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 yourdoctor.

• For oral dosage form (tablets):
  • For breast cancer:
    • Adults?The starting dose is usually 2500 milligrams (mg) persquare meter of body surface area a day, divided into two doses and takenabout 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 takenabout twelve hours apart within 30 minutes after the end of a meal combinedwith docetaxel at 75 mg per square meter of body surface area as a 1 hourinfusion 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) persquare meter of body surface area a day, divided into two doses and takenabout 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 takethe missed dose at all and do not double the next one. Instead, go back toyour 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 otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat 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 atregular visits to make sure that this medicine is working properlyand to check for unwanted effects.

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

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

Stop taking this medicine and check with your doctorimmediately 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 yourhands and/or the bottoms of your feet that is severe enough to interfere withyour 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 onyour lips that are severe enough to interfere with eating.

If vomiting occurs less often than mentioned above, or if nausea does notcause you to eat less than usual, it is not necessary for you to stop takingthe medicine or to check with your doctor (unless these effects are particularlybothersome). Also, you do not need to stop taking the medicine if diarrheaoccurs less often than mentioned above or if the other side effects listedare 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 treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval. Capecitabine may lower your body'sresistance and there is a chance you might get the infection the immunizationis meant to prevent. In addition, other persons living in your household shouldnot take oral polio vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral polio vaccine withinthe last several months. Do not get close to them, and do not stay in thesame room with them for very long. If you cannot take these precautions, youshould consider wearing a protective face mask that covers the nose and mouth.

Capecitabine can temporarily lower the number of white blood cells in yourblood, increasing the chance of getting an infection. It can also lower thenumber of platelets, which are necessary for proper blood clotting. If thisoccurs, there are certain precautions you can take, especially when your bloodcount is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor 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 ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycould occur.

Side Effects of This Medicine

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

Stop taking this medicine and check with your doctor immediately ifany of the following side effects occur:

More common

Diarrhea (moderately severe [four to six stools a day more thanusual, or at night]); pain, blistering, peeling,redness, or swelling of palms of hands and/or bottoms of feet (severe enoughto interfere with normal activities); pain and redness,swelling, or sores or ulcers in your mouth or on your lips (severe enoughto interfere with eating)

Less common

Nausea (severe, accompanied by loss of appetite); vomiting (severe [occurring two times or more in 24 hours])

Also check with your doctor immediately if any of the following side effectsoccur:

Less common or rare

Abdominal or stomach cramping or pain (severe); agitation; back pain; bleeding and bruising; bleeding gums; blood in urine or stools; bloody nose; bloody or black, tarry stools; bloody nose; blurred vision; burning, dry or itching eyes; chest pain; chills; cold; collapse; coma; confusion; constipation (severe); convulsions; cough or hoarseness (accompanied byfever or chills); cough producing mucus; coughing or spitting up blood; decreasedfrequency/amount of urine; difficulty breathing; difficulty in swallowing or pain in back of throat or chest whenswallowing; discharge from eye; drowsiness; dry mouth; excessive tearing; extra heartbeats; eye redness, irritation, or pain; fainting; fast or irregular heartbeat; fever or chills; flu-like symptoms; hallucinations; headache, sudden andsevere; heavier menstrual periods; high fever; hot, red skin on feet or legs; inability to speak; increased bloodpressure; increased menstrual flow or vaginal bleeding; increased thirst; irritability; itching in genital or other skin areas; large amount of triglycerides in the blood; lightheadedness; loss of consciousness; lower back or side pain (accompanied by fever or chills); mood or mental changes; muscle achesor cramps; muscle spasms; nosebleeds; numbness or tingling in hands, feet,or lips; painful or difficult urination (accompaniedby fever or chills); painful, swollen feet or legs; pain, tenderness, and/or swelling in upper abdominal(stomach) area; pale skin; paralysis; pinpoint red spots on skin; prolonged bleeding from cuts; rapid,shallow breathing; red or dark brown urine; redness, pain, swelling or eye, eyelid or inner lining of eyelid; scaling; seizures; severe constipation; severe vomiting; shortness of breath, troubled breathing, tightnessin chest, and/or wheezing; slow or irregular heartbeat; slurred speech; sneezing,sore throat, and/or stuffy nose; sores, ulcers orwhite spots on lips or in mouth; stiff neck; stomach bloating, burning, cramping, or pain; swelling of lymph nodes; temporary blindness; tiredness or weakness (severe); troublein speaking; twitching seizures; unusual bleeding or bruising; unusual lump or swellingin the chest; vomiting blood or material that lookslike coffee grounds; weakness in arm and/or leg onone side of the body, sudden and severe; weight gain; weight loss; wheezing; white patches in the mouth or throat or on thetongue; white patches with diaper rash; yellow eyes or skin

Incidence not known

Continuing vomiting; dark-colored urine; general feeling of tiredness or weakness

Also, check with your doctor as soon as possible if any of the followingside effects occur:

More common

Abdominal or stomach pain (mild or moderate); blistering, peeling, redness, and/or swelling of palms of hands or bottomsof feet (not severe enough to interfere with daily activities); diarrhea (mild [fewer than four stools a day more than usual]); numbness, pain, tingling, or other unusual sensationsin palms of hands or bottoms of feet; pain and redness,swelling, or sores or ulcers in your mouth or on your lips (not severe enoughto interfere with eating); unusual tiredness or weakness(mild or moderate); yellow eyes or skin

Less common or rare

Clumsiness or unsteadiness; dark urine; decrease or increase in blood pressure; light-colored stools; problems withcoordination; skin rash or itching; swelling of face, fingers, feet, or lower legs; swollen glands; unexplained nosebleeds

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Constipation (mild or moderate); lossof appetite (not due to nausea); nausea (not accompaniedby loss of appetite); vomiting (mild [once a dayor less])

Less common

Burning, crawling, itching, numbness, prickling, ?pinsand needles? or tingling feelings; changesor discoloration in fingernails or toenails; difficultyin moving; discouragement; dizziness; fatigue; headache; heartburn; increase inheart rate; increased sensitivity of skin to sunlight; muscle pain; pain; pain in joints; pain in limbs; pain and redness of skin at place of earlier radiation (x-ray)treatment; red, sore eyes; sunken eyes; thirst; troublein sleeping; weakness; wrinkled skin

Rare

Bone pain; change in color of treatedskin; difficulty in walking; discouragement; dryness or soreness or throat; feeling of constant movement of self or surroundings; feeling sad or empty; full feeling inabdomen; full or bloated feeling or pressure in thestomach; general feeling of discomfort or illness; hoarseness; hot flushes; impaired balance; increasedweight; joint pain; lackof appetite; loss of interest or pleasure; muscle weakness; noisy breathing; pain in rectum; pain, swelling, or rednessin joints; passing less gas; rough, scratchy sound to voice; runny nose; sensation of spinning; shakiness inlegs, arms, hands, feet; shivering; sleepiness; sores on the skin; sweating increased; swelling of abdominalor stomach area; tremor or shaking of hands or feet; trouble concentrating; voice changes

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