Pronunciation:

ka-pe-SITE-a-been

Brand Names:

• Xeloda

Dosage Forms:

• Tablet

Warnings:

Capecitabine Warfarin interaction: Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important capecitabine-Warfarin drug interaction was demonstrated in a clinical pharmacology trial. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Postmarketing reports have shown clinically significant increases in prothrombin time (PT) and INR in patients who were stabilized on anticoagulants at the time capecitabine was introduced. These events have occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within 1 month after stopping capecitabine. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy .

Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antimetabolite

Uses of This Medicine:

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

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 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.

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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.

Other 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

Other interactions—

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 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 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 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 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.

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.

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

More common

Diarrhea (moderately severe [four to six stools a day more than usual, or at night])

pain and redness, swelling, or sores or ulcers in your mouth or on your lips (severe enough to interfere with eating)

pain, blistering, peeling, redness, or swelling of palms of hands and/or bottoms of feet (severe enough to interfere with normal activities)

Less common

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:

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

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, swelling or eye, eyelid or inner lining of eyelid

scaling

seizures

severe constipation

severe vomiting

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

weight loss

wheezing

white patches in the mouth or throat or on the tongue

white patches with diaper rash

yellow eyes or skin

Incidence not known

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:

More common

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 and redness, swelling, or sores or ulcers in your mouth or on your lips (not severe enough to 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 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:

More common

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])

Less common

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

Rare

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, 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.