Xeloda

DRUG DESCRIPTION

XELODA (capecitabine) is a fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5-fluorouracil.

The chemical name for capecitabine is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35. Capecitabine has the following structural formula:

XELODA® (capecitabine) Structural Formula Illustration

Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C.

XELODA (capecitabine) is supplied as biconvex, oblong film-coated tablets for oral administration. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in XELODA (capecitabine) include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides.

What are the possible side effects of capecitabine (Xeloda)?

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:

  • severe diarrhea (more than 4 times per day, or during the night);
  • vomiting (more than once in 24 hours);
  • nausea, loss of appetite, eating much less than usual;
  • weakness, feeling light-headed, hot or dry skin;
  • pain, tenderness, redness, swelling,...

Read All Potential Side Effects and See Pictures of Xeloda »

What are the precautions when taking capecitabine (Xeloda)?

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease, a certain enzyme deficiency (dihydropyrimidine dehydrogenase deficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., bone marrow suppression), heart problems (e.g., coronary artery disease, heart failure), kidney problems, liver...

Read All Potential Precautions of Xeloda »


Xeloda Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, loss of appetite, constipation, tiredness, weakness, back/joint/muscle pain, headache, dizziness, trouble sleeping, skin darkening, or dry/itchy skin may occur. Nausea and vomiting can be severe. Changes in diet and lifestyle, such as eating several small meals or limiting activity, may lessen some of these effects. If any of these effects continue or worsen, notify your doctor.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended. Temporary nail changes may occur, which may rarely include fungal infections in the nail beds.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Diarrhea is a common side effect of this medication. It may become very severe (possibly fatal). To decrease this side effect, your doctor may prescribe medication (e.g., loperamide) to control your symptoms, replace lost fluids by vein, or stop treatment with capecitabine. Drink plenty of fluids to prevent serious problems due to a loss of too much body water (dehydration). If you experience signs of severe diarrhea (e.g., 4 or more stools per day, diarrhea at night, bloody stools), or if you experience signs of dehydration (e.g., dizziness, decreased amount of urine), stop taking this drug and tell your doctor immediately.

Stop taking capecitabine and tell your doctor immediately if you have any of these serious side effects: severe nausea/vomiting (vomiting 2 or more times per day, inability to eat or keep food/fluids in your stomach), painful redness/swelling/sores in mouth or throat.

If any of the above symptoms occur, your doctor may lower your dose when you start taking capecitabine again or may stop treatment with this drug.

Treatment with capecitabine may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). You can prevent or reduce these problems by protecting your hands and feet from a great deal of heat or pressure. Avoid unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may prescribe a medication to reduce the symptoms or decrease/delay your next dose of capecitabine. If you experience pain/swelling/redness, blisters, or numbness of the hands/feet that affects your usual activities, stop taking this medication and tell your doctor immediately.

This medication can lower your ability to fight an infection. Stop taking this medication and call your doctor promptly if you develop any signs of an infection such as high fever, chills, or persistent sore throat.

Tell your doctor immediately if you have any of these unlikely but serious side effects: abdominal/stomach pain, unusual bruising or bleeding, extreme tiredness, mental/mood changes (e.g., depression), swelling of the ankles/feet, vision changes, shortness of breath, change in the amount of urine, dark urine, yellowing of the eyes/skin, fast/irregular heartbeat.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fainting, jaw/left arm pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, 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.

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease, a certain enzyme deficiency (dihydropyrimidine dehydrogenase deficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., bone marrow suppression), heart problems (e.g., coronary artery disease, heart failure), kidney problems, liver problems.

Wash your hands well to prevent the spread of infections.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use an effective sunscreen and wear protective clothing when outdoors. This will also help protect you from problems related to heat (hand/foot syndrome). See Side Effects section for more information.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lower the risk of bleeding gums.

Caution is advised when this drug is used in the elderly because they may be more sensitive to the side effects of this medication, especially nausea, vomiting, and diarrhea.

This drug is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use two effective forms of birth control (e.g., condoms and birth control pills) while taking this medication.

It is not known if this drug passes into breast milk. Because of possible harm to the nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Xeloda Patient Information Including Side Effects

Brand Names: Xeloda

Generic Name: capecitabine (Pronunciation: KAP e SYE ta been)

  • What is capecitabine (Xeloda)?
  • What are the possible side effects of capecitabine (Xeloda)?
  • What is the most important information I should know about capecitabine (Xeloda)?
  • What should I discuss with my healthcare provider before taking capecitabine (Xeloda)?
  • How should I take capecitabine (Xeloda)?
  • What happens if I miss a dose (Xeloda)?
  • What happens if I overdose (Xeloda)?
  • What should I avoid while taking capecitabine (Xeloda)?
  • What other drugs will affect capecitabine (Xeloda)?
  • Where can I get more information?

What is capecitabine (Xeloda)?

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

What are the possible side effects of capecitabine (Xeloda)?

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:

  • severe diarrhea (more than 4 times per day, or during the night);
  • vomiting (more than once in 24 hours);
  • nausea, loss of appetite, eating much less than usual;
  • weakness, feeling light-headed, hot or dry skin;
  • pain, tenderness, redness, swelling, blistering, or peeling skin on your hands or feet;
  • fever, chills, body aches, flu symptoms;
  • swelling, white patches, or sores in your mouth or throat;
  • jaundice (yellowing of the skin or eyes);
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness, weakness, headache, confusion, or problems with vision, speech, or balance; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

  • stomach pain or upset, constipation;
  • tired feeling;
  • temporary hair loss;
  • mild skin rash;
  • headache, dizziness;
  • altered sense of taste;
  • back pain, joint or muscle pain;
  • eye irritation.

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 is the most important information I should know about capecitabine (Xeloda)?

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.

Do not use capecitabine if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking capecitabine, whether you are a man or a woman. Tell your doctor if a pregnancy occurs during treatment.

You should not breast-feed while you are taking capecitabine.

Before you take capecitabine, tell your doctor if you have liver or kidney disease, a history of coronary artery disease, or if you are also taking folic acid (contained in many vitamin and mineral supplements), leucovorin (Wellcovorin), phenytoin (Dilantin), or a blood thinner (warfarin, Coumadin).

While taking capecitabine, you will need blood tests at your doctor's office on a regular basis. Do not miss any appointments. You must remain under the care of a doctor while you are taking capecitabine.

Call your doctor at once if you have a serious side effect such as severe vomiting or diarrhea, fever or flu symptoms, pain or redness of your hands or feet, jaundice (yellowing of the skin or eyes), chest pain, sudden numbness or weakness, or fainting.

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