Xeloda

Description:

Xeloda (CAPECITABINE) is the only FDA-approved oral chemotherapy for both metastatic breast cancer and adjuvant and metastatic colorectal cancer. Inactive in pill form, Xeloda is enzymatically activated within the body; when it comes into contact with a naturally occurring protein called thymidine phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic (cell-killing) drug. Because many cancers have higher levels of TP than does normal tissue, more 5-FU is delivered to the tumor than to other tissue.
A drug used to treat stage III colon cancer in patients who had surgery to remove the cancer. It is also used to treat metastatic breast cancer that has not improved after treatment with certain other anticancer drugs. Xeloda is being studied in the treatment of other types of cancer. It is taken up by cancer cells and breaks down into 5-fluorouracil, a substance that kills tumor cells. Xeloda is a type of antimetabolite. Also called capecitabine.

Product Description

Common uses

Xeloda is used alone or with other treatments/medications to treat certain types of cancer (e.g., of the breast, colon, rectum). It works by slowing or stopping cancer cell growth and by decreasing tumor size.

Before using

Tell your doctor if you:
• take a blood thinner such as warfarin (Coumadin). Xeloda may increase the effect of the blood thinner. Your doctor will need to test your blood more often and adjust the dose of your blood thinner if needed.
• take phenytoin. Your doctor will need to test your blood more often and adjust the dose if needed.
• are pregnant.
• have kidney problems.
• have liver problems.
• take the vitamin, folic acid.

Directions

Read the Patient Information Leaflet provided by your pharmacist before you start taking capecitabine and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Take this medication by mouth, usually twice daily in the morning and evening or as directed by your doctor. It is best to take this with a full glass of water (8 ounces or 240 milliliters) within 30 minutes after the end of a meal. Capecitabine is usually taken every day for 2 weeks, then stopped for 1 week. This course of treatment may be repeated as directed by your doctor.
If you take any antacid products that contain aluminum or magnesium, take capecitabine 2 hours before or after taking any antacids because these products may change the way your body absorbs capecitabine.
The dosage is based on your medical condition, body size, and response to therapy. You may be taking a combination of different tablet sizes. Pay close attention to your dose and tablet sizes to avoid over- or under-dosing.
Do not increase your dose or take this medication more often than directed without your doctor's approval. Your condition will not improve any faster, and the risk of serious side effects may increase.
Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication.

Cautions

Xeloda 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 Xeloda-Warfarin drug interaction was demonstrated in a clinical pharmacology trial. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking Xeloda 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 Xeloda was introduced. These events occurred within several days and up to several months after initiating Xeloda therapy and, in a few cases, within 1 month after stopping Xeloda. 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.

Possible side effects

Side effects from capecitabine are common and include:
• diarrhea
• nausea
• vomiting
• stomach pain
• constipation
• weakness
• tiredness
• dizziness
• headache
• sleeplessness
• dry or itching skin
• dehydration
If you experience any of the following symptoms or the one listed in the IMPORTANT WARNING section, call your doctor immediately:
• severe diarrhea (more than four bowel movements each day or diarrhea at night)
• decreased appetite (complete loss of appetite or only able to eat occasionally)
• severe vomiting (more than one time in a 24-hour period)
• tingling, numbness, pain, redness, or swelling of the hands or feet
• sores or pain in the mouth or throat
• fever or infection (a temperature of 100.5 degrees F or greater)
• chills
• sore throat
• chest pain
• rash

If you take too much

Symptoms and Treatment: The manifestations of acute overdose include: nausea, vomiting, diarrhea, mucositis, gastrointestinal irritation and bleeding, and bone marrow depression. Management of overdose should include customary therapeutic and supportive medical interventions aimed at correcting the presenting clinical manifestations and preventing their possible complications.

Additional information

Xeloda can cause tingling, numbness, pain, swelling, or redness in the palms of your hands or soles of your feet (hand and foot syndrome). Stop taking Xeloda and contact your doctor if you have signs of this syndrome. Your doctor may want to decrease your dose or stop your treatment with Xeloda.

Drug interactions

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially:
• folic acid (including multivitamins with folic acid)
• leucovorin
• metronidazole
• tinidazole

This drug can change the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include:
• "blood thinners" (e.g., warfarin)
• fosphenytoin
• phenytoin

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting capecitabine.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.