Xeloda

Generic Name: capecitabine (Oral route)

kap-e-SYE-ta-been

Commonly used brand name(s):

In the U.S.

• Xeloda

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Uses For Xeloda

Capecitabine 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.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, capecitabine is used in certain patients with the following medical conditions:

• Advanced or metastatic stomach cancer, first-line therapy.
• Metastatic colorectal cancer (cancer of the colon or rectum that has spread to other areas of the body), first-line therapy, in combination with bevacizumab and oxaliplatin.

Before Using Xeloda

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

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.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bacillus of Calmette and Guerin Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Warfarin
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Leucovorin
• Levoleucovorin
• Phenytoin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. 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.

• Infection—Capecitabine decreases your body's ability to fight infection.

• 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.

Proper Use of Xeloda

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Xeloda

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 degrees 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.

Xeloda Side Effects

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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

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

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

Check with your doctor immediately if any of the following side effects occur:

• 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
• blurred vision
• burning, dry, or itching eyes
• chest pain
• chills
• cold
• collapse
• coma
• confusion
• constipation (severe)
• convulsions
• cough or hoarseness (accompanied by fever or chills)
• cough producing mucus
• coughing or spitting up blood
• decreased frequency/amount of urine
• difficulty breathing
• difficulty in swallowing or pain in back of throat or chest when swallowing
• 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 and severe
• heavier menstrual periods
• high fever
• hot, red skin on feet or legs
• inability to speak
• increased blood pressure
• 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 aches or cramps
• muscle spasms
• nosebleeds
• numbness or tingling in hands, feet, or lips
• painful or difficult urination (accompanied by 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, or swelling of eye, eyelid, or inner lining of eyelid
• scaling
• seizures
• severe constipation
• shortness of breath, troubled breathing, tightness in chest, and/or wheezing
• slow or irregular heartbeat
• slurred speech
• sneezing, sore throat, and/or stuffy nose
• sores, ulcers, or white spots on lips or in mouth
• stiff neck
• stomach bloating, burning, cramping, or pain
• swelling of lymph nodes
• temporary blindness
• tiredness or weakness (severe)
• trouble in speaking
• twitching seizures
• unusual bleeding or bruising
• unusual lump or swelling in the chest
• vomiting blood or material that looks like coffee grounds
• weakness in arm and/or leg on one side of the body, sudden and severe
• weight gain or loss
• wheezing
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash
• yellow eyes or skin

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

Check with your doctor as soon as possible if any of the following side effects occur:

• Abdominal or stomach pain (mild or moderate)
• blistering, peeling, redness, and/or swelling of palms of hands or bottoms of 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 sensations in palms of hands or bottoms of feet
• pain, redness, swelling, sores, or ulcers in your mouth or on your lips (not severe enough to interfere with eating)
• unusual tiredness or weakness (mild or moderate)

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation (mild or moderate)
• loss of appetite (not due to nausea)
• nausea (not accompanied by loss of appetite)
• vomiting (mild [once a day or less])

• Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• changes or discoloration in fingernails or toenails
• difficulty in moving
• discouragement
• dizziness
• fatigue
• headache
• heartburn
• increase in heart 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
• trouble in sleeping
• weakness
• wrinkled skin

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

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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