Xeloda is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body.

Xeloda is used alone or in combination chemotherapy to treat colon cancer, breast cancer, or colorectal cancer.

Xeloda is sometimes used when cancer has spread to other parts of the body (metastatic).

You should not take Xeloda if you have severe kidney disease or a metabolic disorder called DPD (dihydropyrimidine dehydrogenase) deficiency.

If you take a blood thinner (warfarin, Coumadin, Jantoven), you may need to have more frequent "INR" or prothrombin time tests. Taking a blood thinner can increase your risk of severe bleeding while you are using Xeloda, and for a short time after you stop taking this medicine. This risk is higher in adults older than 60.

Take Xeloda exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Xeloda is usually taken twice per day, and may be only part of a treatment program that may also include other medications taken on different schedules. Follow your doctor's dosing instructions very carefully.

Take with food or within 30 minutes after eating a meal.

Swallow the tablet whole with water and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the tablet.

Xeloda is given in a 3-week treatment cycle, and you may only need to take the medicine only on certain days of this cycle.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea.

You may need frequent medical tests and your cancer treatments may be delayed based on the results. Xeloda can have long lasting effects on your body. You may also need medical tests for a short time after your last dose.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose of Xeloda for Colorectal Cancer:

MONOTHERAPY:
For first line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred:
-RECOMMENDED DOSE: 1250 mg/m2 orally 2 times a day (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles

ADJUVANT TREATMENT IN PATIENTS WITH DUKES' C COLON CANCER:
-RECOMMENDED DOSE: 1250 mg/m2 orally 2 times a day (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles for a total of 8 cycles (24 weeks)

Comments:
-The tablets should be swallowed whole with water within 30 minutes after a meal.

Use:
Colorectal Cancer:
-As monotherapy for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred; this drug was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS); physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing this drug as a single-agent in the adjuvant treatment of Dukes' C colon cancer
-As first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred; combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone; survival benefit over 5-FU/LV has not been demonstrated with this drug as monotherapy; use of this drug instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage

Usual Adult Dose of Xeloda for Breast Cancer:

MONOTHERAPY:
-RECOMMENDED DOSE: 1250 mg/m2 orally 2 times a day (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period combined with docetaxel 75 mg/m2 as a 1 hour IV infusion, every 3 weeks
IN COMBINATION WITH DOCETAXEL:
-RECOMMENDED DOSE: 1250 mg/m2 orally 2 times a day (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles

Comments:
-The manufacturer prescribing information for docetaxel should be consulted for premedication advice.
-The tablets should be swallowed whole with water within 30 minutes after a meal.

Use:
Breast Cancer:
-In combination with docetaxel for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy
-As monotherapy for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents); resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen

You should not take Xeloda if you are allergic to capecitabine or fluorouracil, or if you have:

• severe kidney disease.

To make sure Xeloda is safe for you, tell your doctor if you have ever had:

• a metabolic disorder called DPD (dihydropyrimidine dehydrogenase) deficiency;

• liver or kidney disease;

• heart problems; or

• if you use a blood thinner and you have routine "INR" or prothrombin time tests.

Capecitabine can harm an unborn baby if the mother or the father is using Xeloda .

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using Xeloda and for at least 6 months after your last dose.

• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using Xeloda, and for at least 2 weeks after your last dose.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Xeloda (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Diarrhea may occur and could be severe. Stop taking Xeloda and tell your doctor right away if the number of bowel movements you usually have per day increases by 4 or more, or if you have bowel movements at night.

Stop using Xeloda and call your doctor at once if you have:

• severe diarrhea;

• bloody diarrhea with severe stomach pain and fever;

• severe nausea or loss of appetite that causes you to eat much less than usual;

• vomiting (more than once in 24 hours);

• fever above 100.5 degrees;

• sores or ulcers in your mouth, redness or swelling of your mouth or tongue, trouble eating or swallowing;

• jaundice (yellowing of the skin or eyes);

• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• "hand and foot syndrome" - pain, tenderness, redness, swelling, blistering, or peeling skin on your hands or feet;

• heart problems - chest pain, irregular heartbeats, swelling in your lower legs, rapid weight gain, feeling lightheaded or short of breath; or

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Xeloda side effects may include:

• nausea, vomiting, diarrhea, stomach pain;

• feeling weak or tired;

• hand and foot syndrome; or

• jaundice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking a blood thinner (warfarin, Coumadin, Jantoven) can increase your risk of severe bleeding during and shortly after treatment with Xeloda. This risk is higher in adults older than 60.

Tell your doctor if you also take allopurinol.

Other drugs may interact with capecitabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.