Capecitabine Tablets

What is this medication?

CAPECITABINE (ka pe SITE a been) treats some types of cancer. It works by slowing down the growth of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Xeloda

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
• Heart disease
• Kidney disease
• Liver disease
• Low blood cell levels (white cells, red cells, and platelets)
• Take medication that treats or prevents blood clots
• An unusual or allergic reaction to capecitabine, fluorouracil, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it within 30 minutes after a meal. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

This medication is taken in cycles. There will be days you do not take it. Talk to your care team if you have questions about when to take your medication. It is very important to follow the exact schedule. Taking it more often than directed can cause serious side effects.

Handling this medication may be harmful. Wear gloves while touching the medication or bottle. Talk to your care team about how to handle this medication. Special instructions may apply.

Talk to your care team about the use of this medication in children. Special care may be needed.

People 65 years and older may have a stronger reaction.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

• Allopurinol
• Aspirin and aspirin-like medications
• Cyclosporine
• Diuretics
• Folic acid
• Leucovorin
• Medications for infection, such as acyclovir, adefovir, amphotericin B, bacitracin, cidofovir, foscarnet, ganciclovir, gentamicin, pentamidine, vancomycin
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Pamidronate
• Phenytoin
• Warfarin
• Zoledronic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Report any side effects. Continue your course of treatment even if you have side effects unless your care team tells you to stop.

This medication may make you feel generally unwell. This is not uncommon with medications used to treat cancer. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work done while you are taking this medication.

This medication may cause serious side effects. People with a DPYD gene variant have a higher risk of serious side effects that can occur early during treatment. A variant is a change in the gene code found in most people. Your care team may test you for this before you start this medication. Talk to your care team right away if you have severe symptoms of pain, redness, or swelling with sores inside your mouth or throat; diarrhea; fever, chills, cough; confusion, trouble speaking; loss of balance, trouble walking; difficulty with memory or paying attention.

Taking this medication with blood thinners can increase the risk of bleeding. Talk to your care team about all the medications, vitamins, and supplements you take. If you need to take a blood thinner, your care team may check your blood more often during and after treatment. Talk to your care team right away if you have black tar-like stools, unusual bruising or bleeding, red or dark brown urine, or if you vomit blood.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

Talk to your care team if you do not feel like you want to eat or drink or if you have nausea, vomiting, or diarrhea. It is important to stay hydrated while you are taking this medication. The loss of too much body fluid can cause serious side effects.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Talk to your care team if you or your partner may be pregnant. Serious fetal side effects can occur if you take this medication during pregnancy and for 6 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 6 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 3 months after the last dose.

Do not breastfeed while taking this medication and for 1 week after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Pain, redness, or swelling with sores inside the mouth or throat
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Redness, swelling, and blistering of the skin over hands and feet
• Unusual bruising or bleeding
• Severe or prolonged diarrhea

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Fatigue
• Nausea
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.