Pronunciation:

kap-e-SYE-ta-been

Brand Names:

• Xeloda

Dosage Forms:

• Tablet

Warnings:

Warning: Increased Risk of Bleeding with Concomitant Use of Vitamin K AntagonistsAltered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine concomitantly with oral vitamin K antagonists, such as warfarin.Clinically significant increases in prothrombin time (PT) and international normalized ratio (INR) have been reported in patients who were on stable doses of a vitamin K antagonist at the time capecitabine was introduced. These events occurred within several days and up to several months after initiating capecitabine and, in a few cases, within 1 month after stopping capecitabine. These events occurred in patients with and without liver metastases.Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antimetabolite

Uses of This Medicine:

Capecitabine is used alone or in combination with other cancer treatments in patients with colon cancer that has spread (Stage III) to help prevent colon cancer from coming back after surgery. It is also used together with other cancer treatments and radiation treatment, around the time of surgery, to treat rectal cancer that has spread. This medicine is also used alone or in combination with other cancer treatments to treat colorectal cancer that has spread or cannot be removed by surgery.

Capecitabine is also used together with docetaxel to treat breast cancer that has spread throughout the body in patients who have received other medicines (eg, anthracycline medicine) that did not worked well. This medicine is also used alone to treat breast cancer in patients who are not able to receive anthracycline medicine or taxane medicine.

Capecitabine is also used in combination with other cancer treatments to treat esophageal, gastric (stomach), or gastroesophageal junction in patients whose cancer has spread or cannot be removed by surgery. It is also used to treat esophagus, stomach, or gastroesophageal junction adenocarcinoma that has spread throughout the body in patients whose cancer has an abnormal HER2 gene and who have not received other cancer treatments.

Capecitabine is also used in combination with other cancer treatments to prevent pancreatic cancer from coming back after surgery.

Capecitabine belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by the medicine, other side effects may also occur. Some of these may be serious and must be reported to your doctor.

This medicine is available only with your doctor's prescription.

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—

Appropriate studies have not been performed on the relationship of age to the effects of capecitabine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of capecitabine in the elderly. However, elderly patients are more likely to have unwanted side effects (eg, stomach problems, severe diarrhea, nausea or vomiting, which may require caution and an adjustment in the dose for patients receiving capecitabine.

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—

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Tegafur
• Varicella Virus Vaccine, Live
• Zoster 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.

• Aceclofenac
• Acenocoumarol
• Adenovirus Vaccine, Live
• Allopurinol
• Azanidazole
• Bacillus of Calmette and Guerin Vaccine, Live
• Benznidazole
• Brivudine
• Carvedilol
• Cedazuridine
• Celecoxib
• Cholera Vaccine, Live
• Cimetidine
• Dengue Tetravalent Vaccine, Live
• Dexlansoprazole
• Diclofenac
• Ebola Zaire Vaccine, Live
• Esomeprazole
• Etravirine
• Fluvastatin
• Folic Acid
• Fosphenytoin
• Glimepiride
• Glyburide
• Influenza Virus Vaccine, Live
• Irbesartan
• Isoconazole
• Lansoprazole
• Leucovorin
• Levoleucovorin
• Losartan
• Methadone
• Methotrexate
• Metronidazole
• Nateglinide
• Nimorazole
• Omeprazole
• Ornidazole
• Pantoprazole
• Phenindione
• Phenprocoumon
• Phenytoin
• Poliovirus Vaccine, Live
• Rabeprazole
• Secnidazole
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Tamoxifen
• Tinidazole
• Tolbutamide
• Torsemide
• Typhoid Vaccine, Live
• 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.

• Levamisole
• Thiamine

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 5-fluorouracil or
• Kidney disease or
• Shortage of an enzyme called dihydropyrimidine dehydrogenase (DPD) that your body needs—Should not be used in patients with these conditions.

• Coronary heart disease, history of—May cause side effects to become worse.

• Dehydration or
• Kidney disease, mild or moderate or
• Liver disease—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with food 30 minutes after you eat. Take this medicine the same time each day.

Swallow the tablet whole with water. Do not cut, crush, or chew it. If the tablet must be cut or crushed, it should be done by a pharmacist.

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:
    • For patients receiving this alone:
      • Adults—Dose is based on body size and must be determined by your doctor. 1000 to 1250 milligrams (mg) per square meter (m(2)) 2 times a day for the first 14 days of each 21-day cycle. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For patients receiving this in combination with docetaxel:
      • Adults—Dose is based on body size and must be determined by your doctor. 1000 to 1250 milligrams (mg) per square meter (m(2)) 2 times a day for the first 14 days of each 21-day cycle.
      • Children—Use and dose must be determined by your doctor.
  • For colon cancer:
    • For patients receiving this alone:
      • Adults—Dose is based on body size and must be determined by your doctor. 1250 milligrams (mg) per square meter (m(2)) 2 times a day for the first 14 days of each 21-day cycle for a maximum of 8 cycles.
      • Children—Use and dose must be determined by your doctor.
    • For patients receiving this in combination with oxaliplatin:
      • Adults—Dose is based on body size and must be determined by your doctor. 1000 milligrams (mg) per square meter (m(2)) 2 times a day for the first 14 days of each 21-day cycle for a maximum of 8 cycles.
      • Children—Use and dose must be determined by your doctor.
  • For colorectal cancer:
    • For patients receiving this alone:
      • Adults—Dose is based on body size and must be determined by your doctor. 1250 milligrams (mg) per square meter (m(2)) 2 times a day for the first 14 days of each 21-day cycle.
      • Children—Use and dose must be determined by your doctor.
    • For patients receiving this in combination with oxaliplatin:
      • Adults—Dose is based on body size and must be determined by your doctor. 1000 milligrams (mg) per square meter (m(2)) 2 times a day for the first 14 days of each 21-day cycle.
      • Children—Use and dose must be determined by your doctor.
  • For rectal cancer:
    • For patients receiving this with radiation therapy:
      • Adults—Dose is based on body size and must be determined by your doctor. 825 milligrams (mg) per square meter (m(2)) 2 times a day.
      • Children—Use and dose must be determined by your doctor.
    • For patients receiving this without radiation therapy:
      • Adults—Dose is based on body size and must be determined by your doctor. 1250 milligrams (mg) per square meter (m(2)) 2 times a day.
      • Children—Use and dose must be determined by your doctor.
  • For gastric, esophageal, or gastroesophageal junction cancer:
    • For patients receiving this platinum-containing chemotherapy:
      • Adults—Dose is based on body size and must be determined by your doctor. 625 milligrams (mg) per square meter (m(2)) 2 times a day on days 1 to 21 of 21-day cycle for a maximum of 8 cycles.
      • Children—Use and dose must be determined by your doctor.
    • For patients receiving this in combination with oxaliplatin:
      • Adults—Dose is based on body size and must be determined by your doctor. 850 to 1000 milligrams (mg) per square meter (m(2)) 2 times a day for the first 14 days of each 21-day cycle. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For patients receiving this in combination with cisplatin and trastuzumab:
      • Adults—Dose is based on body size and must be determined by your doctor. 1000 milligrams (mg) per square meter (m(2)) 2 times a day for the first 14 days of each 21-day cycle.
      • Children—Use and dose must be determined by your doctor.
  • For pancreatic cancer:
    • For patients receiving this alone:
      • Adults—Dose is based on body size and must be determined by your doctor. 830 milligrams (mg) per square meter (m(2)) 2 times a day for the first 21 days of each 28-day cycle.
      • 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.

If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.

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 doctor 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 a blood thinner.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before taking this medicine. Female patients must use effective birth control during treatment and for 6 months after your treatment ends. Male patients with partners of childbearing potential should also use effective contraception during treatment and for 3 months after the last dose. Tell your doctor right away if you think you have become pregnant.

This medicine may increase risk of bleeding when used together with a blood thinner (eg, warfarin). Check with your doctor right away if you have back pain, blood in the eyes, blood in the urine, black, tarry stools, bruising or purple areas on the skin, coughing up blood, decreased alertness, dizziness, headache, joint pain or swelling, or nosebleeds.

This medicine may cause heart problems. Check with your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, chest tightness, decreased urine output, dilated neck veins, faintness, nausea, sweating, swelling in your hands, ankles, or feet, trouble breathing, unusual sweating, vomiting.

This medicine may cause kidney problems. Check with your doctor right away if you have agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Check with your doctor right away if any of the following symptoms occur:

• Diarrhea, moderately severe (four to six stools a day more than usual, or during the night).
• Nausea that is severe enough to cause you to eat less than usual.
• Vomiting two or more times 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.

Check with your doctor right away if you have confusion, decreased urination, dizziness, dry mouth, fainting, increase in heart rate, lightheadedness, rapid breathing, sunken eyes, thirst, unusual tiredness or weakness, or wrinkled skin. These may be symptoms of dehydration.

Serious skin reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, unusual tiredness or weakness, or fever or chills while you are using this medicine.

This medicine may cause a serious skin problem called palmar plantar erythrodysesthesia syndrome. Check with your doctor if you have a rash that does not go away or redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.

While you are being treated with capecitabine, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Capecitabine may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

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 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. 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.

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.

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.

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

More common

Diarrhea

loss of fingerprints

nausea

numbness, pain, tingling, or other unusual sensations in the palms of the hands or bottoms of the feet

pain, blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet

pain, redness, swelling, sores, or ulcers in your mouth or on your lips

stomach pain

unusual tiredness or weakness

vomiting

Less common or rare

Agitation

back pain

bleeding and bruising

bleeding gums

blood in the urine or stools

bloody nose

bloody or black, tarry stools

blurred vision

burning, dry, or itching eyes

chest pain or tightness

chills

clumsiness or unsteadiness

cold

collapse

coma

confusion

constipation

cough or hoarseness (accompanied by fever or chills)

cough producing mucus

coughing or spitting up blood

dark urine

decreased frequency or amount of urine

difficulty with breathing

difficulty with swallowing or pain in the back of throat or chest when swallowing

discharge from the eyes

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 the feet or legs

inability to speak

increased menstrual flow or vaginal bleeding

increased thirst

irritability

itching in the genital or other skin areas

lightheadedness

light-colored stools

loss of consciousness

lower back or side pain (accompanied by fever or chills)

muscle aches, cramps, or spasms

nosebleeds

numbness or tingling in the hands, feet, or lips

painful or difficult urination (accompanied by fever or chills)

painful, swollen feet or legs

pain, tenderness, or swelling in the upper abdominal or stomach area

pale skin

paralysis

pinpoint red spots on the skin

problems with coordination

prolonged bleeding from cuts

rapid, shallow breathing

red or dark brown urine

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

scaling

seizures

severe constipation

skin rash or itching

slow or irregular heartbeat

slurred speech

sneezing

sores, ulcers, or white spots on the lips or in the mouth

sore throat

stiff neck

stomach bloating, burning, or cramping

stuffy nose

swelling of the face, fingers, feet, or lower legs

swelling of the lymph nodes

swollen glands

temporary blindness

trouble with speaking

trouble breathing

unexplained nosebleeds

unusual bleeding or bruising

unusual lump or swelling in the chest

unusual tiredness or weakness

vomiting blood or material that looks like coffee grounds

weakness in the arm or leg on one side of the body, sudden and severe

weight gain or loss

white patches in the mouth or throat or on the tongue

white patches with diaper rash

yellow eyes or skin

Incidence not known

Blistering, peeling, or loosening of the skin

chest discomfort or heaviness

dilated neck veins

dizziness

eye irritation or pain

irregular breathing

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

no blood pressure or pulse

pain or discomfort in the arms, jaw, back, or neck

red irritated eyes

red skin lesion, often with a purple center

stopping of heart

sweating

unconsciousness

weight gain

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:

Less common

Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings

changes or discoloration in the fingernails or toenails

difficulty with moving

discouragement

headache

heartburn

increased sensitivity of the skin to sunlight

muscle pain

pain

pain and redness of the skin at the place of x-ray treatment

pain in the joints or limbs

red, sore eyes

sunken eyes

thirst

trouble sleeping

weakness

wrinkled skin

Rare

Bone pain

change in color of treated skin

difficulty with walking

discouragement

feeling of constant movement of self or surroundings

feeling sad or empty

full or bloated feeling or pressure in the stomach

general feeling of discomfort or illness

hot flushes

impaired balance

increased sweating

joint pain

lack of appetite

loss of interest or pleasure

muscle weakness

noisy breathing

pain in the rectum

pain, swelling, or redness in the joints

passing less gas

rough, scratchy sound to voice

runny nose

sensation of spinning

shakiness in the legs, arms, hands, or feet

shivering

sores on the skin

swelling of the stomach area

tremor or shaking of the 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.