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What is the most important information I should know about capecitabine?

Capecitabine is used to treat breast cancer and colon or rectum cancer that has spread to other parts of the body.

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

Capecitabine can have long lasting effects on your body. You may need frequent medical tests while you are using this medication and for a short time after your treatment ends.

Capecitabine can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

What is capecitabine?

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

Capecitabine is used to treat breast cancer and colon or rectum cancer that has spread to other parts of the body.

Capecitabine is often used in combination with other cancer medications and/or radiation treatments.

Capecitabine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking capecitabine?

You should not take this medication if you are allergic to capecitabine or fluorouracil (Adrucil), or if you have:

• severe kidney disease; or
• a metabolic disorder called DPD (dihydropyrimidine dehydrogenase) deficiency.

To make sure capecitabine is safe for you, tell your doctor if you have any of these conditions:

• kidney disease;
• liver disease;
• a history of coronary artery disease; or
• if you take a blood thinner (warfarin, Coumadin, Jantoven).

FDA pregnancy category D. Do not use capecitabine if you are pregnant. It could harm the unborn baby.

Use birth control to prevent pregnancy while you are taking capecitabine, whether you are a man or a woman. Tell your doctor if a pregnancy occurs during treatment.

It is not known whether capecitabine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking capecitabine.

How should I take capecitabine?

Follow the directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

During the weeks when you take capecitabine, take the medication once in the morning and once in the evening, unless your doctor tells you otherwise. You may also be given other medications as part of a combination cancer treatment.

Capecitabine should be taken with food or within 30 minutes after eating a meal.

Take this medication with a full glass (8 ounces) of water.

You may need frequent medical tests at your doctor's office to be sure this medication is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests. Capecitabine can have long lasting effects on your body. You may also need medical tests for a short time after your treatment ends.

You must remain under the care of a doctor while you are taking capecitabine.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking capecitabine?

Avoid coming into contact with your body fluids (including urine, feces, vomit, semen, vaginal fluid). Chemotherapy can pass into body fluids. Patients or caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

What are the possible side effects of capecitabine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• nausea, loss of appetite, eating much less than usual, vomiting (more than once in 24 hours);
• severe diarrhea (more than 4 times per day, or during the night);
• bloody, black, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• fever, chills, body aches, flu symptoms, easy bruising or bleeding, white patches or sores inside your mouth or on your lips;
• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
• pain, tenderness, redness, swelling, blistering, or peeling skin on your hands or feet;
• swelling, rapid weight gain; or
• jaundice (yellowing of the skin or eyes).

Common side effects may include:

• stomach pain or upset, constipation;
• tired feeling;
• mild skin rash; or
• numbness or tingling in your hands or feet.

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.

What other drugs will affect capecitabine?

Tell your doctor about all medications you use, and those you start or stop using during your treatment with capecitabine, especially:

• leucovorin;
• phenytoin;
• heart or blood pressure medication;
• oral diabetes medication; or
• NSAIDs (non-steroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with capecitabine, including prescription, over-the-counter, vitamin, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your doctor or pharmacist can provide more information about capecitabine.