capecitabine 500 mg tablet

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Medication name

Generic name:
Capecitabine - oral

Pronunciation
(KAP-e-SYE-ta-been)

Brand name(s)
Xeloda

Warning

People taking capecitabine along with certain "blood thinners" (anticoagulants such as warfarin or phenprocoumon) may have a higher chance of serious, rarely fatal bleeding. Your risk may be higher because you have cancer, or if you are older than 60 years. Bleeding has occurred during treatment and as long as one month after stopping capecitabine.

If you are using an anticoagulant, blood lab tests (INR/PT) will be closely checked. Tell your doctor right away if you have any signs of bleeding or bruising (such as bloody/black/tarry stools).

Uses

Capecitabine is used to treat breast, colon, or rectal cancer. It works by slowing or stopping the growth of cancer cells.

How to use

Read the Patient Information Leaflet if available from your pharmacist before you start taking capecitabine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 2 times a day; once in the morning and once in the evening. Swallow the tablets whole with a full glass of water (8 ounces/240 milliliters) within 30 minutes after a meal. Do not crush or split the tablets. If you have trouble swallowing the tablets whole, ask your health care professional for advice. Your doctor may direct you to take this medication in a treatment cycle. Carefully follow your doctor's instructions.

The dosage is based on your medical condition, body size, and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Side effects

Nausea, vomiting, loss of appetite, constipation, tiredness, weakness, headache, dizziness, trouble sleeping, or changes in taste may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Diarrhea is a common side effect of this medication. Drink plenty of fluids unless directed otherwise. Your doctor may also prescribe medication (such as loperamide) to help lessen diarrhea. Vomiting or diarrhea that doesn't stop may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, or dizziness/lightheadedness.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended. Also, temporary nail changes may occur.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Stop taking capecitabine and tell your doctor right away if any of these very serious side effects occur:

  • severe nausea/vomiting (vomiting 2 or more times per day, unable to eat or keep food/fluids in your stomach)
  • painful redness/swelling/sores in mouth or on your tongue

Capecitabine may make you develop a skin problem called hand-foot syndrome. To help prevent this, protect your hands and feet from heat or increased pressure. Avoid activities such as using hot dishwater, taking tub baths, jogging, long walks, or using garden or household tools such as screwdrivers. Symptoms may include pain, swelling, redness, blisters, or numbness of the hands/feet. Your doctor may prescribe medication (such as balm) to help with symptoms. If symptoms affect your usual activities, get medical help right away.

For men and women of childbearing age, this medication may affect your ability to have children. Ask your doctor for more details.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat that doesn't go away, fever, chills, cough).

Tell your doctor right away if you have any serious side effects, including:

  • easy bruising/bleeding
  • mental/mood changes (such as depression)
  • swelling of the ankles/feet
  • vision changes
  • signs of kidney problems (such as change in the amount of urine)
  • yellowing eyes/skin
  • dark urine

Get medical help right away if you have any very serious side effects, such as:

  • chest/jaw/left arm pain
  • unusual sweating
  • fainting
  • slow/fast/irregular heartbeat

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as:

  • rash/blisters/peeling
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other side effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking capecitabine, tell your doctor or pharmacist if you are allergic to it; or to 5-fluorouracil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • lack of a certain enzyme (dihydropyrimidine dehydrogenase - DPD)
  • blood disorders (such as bone marrow suppression)
  • heart problems (such as heart failure)
  • kidney disease
  • liver problems

Capecitabine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Get medical help right away if you get sunburned or have skin blisters/redness.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this medication, especially nausea, vomiting, diarrhea, and hand-foot syndrome.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using capecitabine. Capecitabine may harm an unborn baby. Ask about reliable forms of birth control. Women of childbearing age should use reliable forms of birth control during treatment and for 6 months after the last dose. Men with female partners of childbearing age should use reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner become pregnant, talk to your doctor right away about capecitabine's risks and benefits.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended during treatment and for 2 weeks after the last dose. Consult your doctor before breast-feeding.

Drug interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

  • allopurinol

Capecitabine is very similar to fluorouracil. Do not use medications containing fluorouracil while using capecitabine.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as bilirubin, complete blood counts, kidney/liver function) should be done while you are taking this medication. Keep all medical and lab appointments.

Missed dose

If you miss a dose, skip the missed dose. Take your next dose at the regular time and check with your doctor. Do not double the dose to catch up.

Storage

Store in a tightly closed container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised March 2019.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.