Capecitabine

Capecitabine may cause serious, life-threatening reactions in people with an inherited condition DPD deficiency (a lack of a naturally occurring enzyme in the body). Your doctor will probably test you to see if you have this condition before starting treatment.

Capecitabine may cause serious or life-threatening bleeding when taken along with anticoagulants ('blood thinners') such as warfarin. Tell your doctor if you are taking warfarin. Your doctor will order laboratory tests to monitor how fast your blood clots and may need to change your dose of warfarin. If you experience any of the following symptoms, call your doctor immediately: unusual bleeding; vomiting or spitting up blood or brown material that resembles coffee grounds; bloody or black, tarry stools; blood in urine; red or dark-brown urine; or easy bruising.

Capecitabine is used to treat breast cancer, colon cancer or rectal cancer (cancer that begins in the large intestine). Capecitabine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells.

Capecitabine comes as a tablet to take by mouth. Take twice a day (in the morning and in the evening) for 2 weeks, followed by a 1-week break before repeating the next dosage cycle. Take after a meal (within 30 minutes of breakfast and dinner) with a glass of water. Your doctor will decide how many times you should repeat this cycle. Take capecitabine at around the same time every day.

Take capecitabine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor may adjust your dose of capecitabine or stop your treatment for a period of time depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Swallow the tablets whole; do not split, chew, or crush them.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Capecitabine is also sometimes used to treat gastric cancer (cancer of the stomach). Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking capecitabine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking capecitabine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had kidney, liver, or heart disease.
• tell your doctor if you are pregnant or plan to become pregnant. You may be required to have a pregnancy test prior to starting capecitabine. You should use birth control during and for 6 months after treatment with capecitabine. Talk to your doctor about what birth control is right for you. If your partner is capable of becoming pregnant, you should use birth control during and for 3 months after treatment with capecitabine. Talk to your doctor about what birth control would work best for you and your partner. Capecitabine may harm the fetus.
• tell your doctor if you are breast-feeding. Do not breast-feed during your treatment with capecitabine.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Capecitabine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• stomach pain or upset stomach
• constipation
• loss of appetite, change in ability to taste food
• increased thirst
• unusual tiredness or weakness
• dizziness
• headache
• hair loss
• rash
• back, joint, or muscle pain
• red, swollen, itchy, or teary eyes
• trouble falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• diarrhea, nausea, vomiting, sores in the mouth
• swelling, pain, redness, or peeling of skin on the palms and soles of the feet
• fever, chills, sore throat, or other signs of an infection
• rash, redness, itching, hives; swelling of the hands, feet, ankles, or lower legs; trouble breathing or swallowing
• chest pain or pressure
• fast heartbeat
• dark urine, yellowing of skin or eyes

Capecitabine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea, vomiting, stomach pain, diarrhea
• fever, chills, sore throat, or other signs of an infection
• black, tarry stools, red urine, unusual bleeding or bruising,
• unusual tiredness or weakness

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to capecitabine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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