Capecitabine (oral route)

Brand Name

US Brand Name

Xeloda

Description

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.

This product is available in the following dosage forms:

Tablet

Before Using

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

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.

Geriatric

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.

Breastfeeding

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.

Drug Interactions

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 Type 4, Live
Adenovirus Vaccine Type 7, 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

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.

Proper Use

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

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

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.

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