Side Effect Reporting
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
What it Treats
Xeloda® (capecitabine) is used to treat:
- cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic colorectal cancer). Xeloda is used as a single drug to treat metastatic colorectal cancer. You should know that in studies, other medicines showed improved survival when they were taken together with 5-FU and leucovorin. In studies, Xeloda used as a single drug was no worse than 5-FU and leucovorin taken together, but did not improve survival compared to these two medicines.
- cancer of the colon after surgery.
- breast cancer that has spread to other parts of the body (metastatic breast cancer). together with another medicine called docetaxel (Taxotere®).
- breast cancer that has spread to other parts of the body and has not improved after treatment with other medicines such as paclitaxel (Taxol®) and anthracycline-containing medicine such as Adriamycin™ and doxorubicin.
Important Safety Information and Serious Side Effects
Xeloda may increase the effect of other medicines used to thin the blood, such as warfarin (Coumadin®). It is very important that a patient's doctor know if the patient is taking a blood thinner such as warfarin because Xeloda may increase the effect of this medicine and could lead to serious side effects. If patients are taking blood thinners and Xeloda, their doctor needs to check more often how fast the patients blood clots and change the dose of the blood thinner, if needed.
- The most common side effects of Xeloda are: diarrhea, nausea, vomiting, sores in the mouth and throat (stomatitis), stomach area pain (abdominal pain), upset stomach, constipation, loss of appetite, and too much water loss from the body (dehydration). These side effects are more common in patients age 80 and older. Other common side effects are hand-and-foot syndrome (palms of the hands or soles of the feet tingle, become numb, painful, swollen or red); rash; dry, itchy or discolored skin; nail problems; hair loss; tiredness; weakness; dizziness; headache; fever; pain (including chest, back, joint and muscle pain); trouble sleeping; and taste problems. Patients must tell their doctor if they have heart problems because they could have more side effects related to their heart
These side effects may differ when taking Xeloda with docetaxel (Taxotere). Patients should consult their doctor for possible side effects that may be caused by taking Xeloda with other therapies.
Patients who are concerned about these or any other side effects while taking Xeloda, should talk to their doctor.
- People must not take Xeloda if they are nursing a baby, and must tell their doctor if they are nursing. Xeloda may pass to the baby in breast milk and harm the baby.
Women should not become pregnant while taking Xeloda. Xeloda may harm a patient's unborn child. Patients must use effective birth control while taking Xeloda. Patients must tell their doctor if they become pregnant. Men should use birth control while taking Xeloda.
People must not take Xeloda if they are allergic to 5-fluorouracil, capecitabine or any of the ingredients in Xeloda. People must not take Xeloda if they have been told that they lack the enzyme DPD (dihydropyrimidine dehydrogenase).
- Patients must stop taking Xeloda immediately and contact their doctor right away if they have the side effects listed below or other side effects that concern them. Their doctor can then adjust Xeloda to a dose that is right for them or stop Xeloda treatment for a while. This should help to reduce the side effects and stop them from getting worse.
- Diarrhea: if patients have an additional 4 bowel movements each day beyond what is normal or any diarrhea at night
- Vomiting: if patients vomit more than once in a 24-hour time period
- Nausea: if patients lose their appetite, and the amount of food they eat each day is much less than usual
- Stomatitis: if patients have pain, redness, swelling or sores in the mouth
- Hand-and-Foot Syndrome: if patients have pain, swelling or redness of the hands or feet that prevents normal activity
- Fever or Infection: if patients have a temperature of 100.5°F or greater or other signs of infection
Patients must talk to their doctor if they have any questions about their condition or treatment.
For full Prescribing Information, including Boxed WARNINGS and Important Safety Information for Xeloda, please visit www.xeloda.com.