Posted on April 28th, 2009 by
Generic Name: Capecitabine (kape-SIGH-te-been)
Trade Name: Xeloda®
For which conditions is this drug approved? Capecitabine is FDA approved for initial treatment for metastatic colorectal cancer, stage III colorectal cancer, treatment for metastatic breast cancer in addition to the chemotherapy agent docetaxel (Taxotere®) after cancer progression following anthracycline chemotherapy, and treatment for metastatic breast cancer in patients who have been treated with both anthracycline and paclitaxel (Taxol®) chemotherapy. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Capecitabine belongs to a group of drugs called antimetabolites. Antimetabolites produce their anti-cancer effects by inhibiting the ability of a cell to produce or repair DNA, thereby making the cell unable to replicate or repair itself and ultimately causing cellular death. This process reduces the size of the tumor.
How is capecitabine typically given (administered)? Capecitabine is administered orally. The specific schedule and dose depend on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with capecitabine. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Patients taking warfarin will need frequent coagulation monitoring to adjust their warfarin dose to decrease the risk of bleeding.
What are the common (occur in 30% or more of patients) side effects of treatment with capecitabine?
• Diarrhea, may be severe
• Hand -foot syndrome characterized by pain, tingling, numbness, peeling skin, rash, swelling, and/or redness of the palms of the hands or the soles of the feet
• Nausea and vomiting
• Skin reactions (increased pigmentation, itching, dry skin)
• Abnormalities in liver function levels as detected on blood tests
• Low levels of red blood cells – increases risk of anemia and blood transfusions
• Lymphopenia (reduced number of lymphocytes—a type of white blood cell—in circulation)
What are the less common (occur in 10% to 29% of patients) side effects of treatment with capecitabine?
• Low white blood cell levels – increases risk of infection
• Low platelet levels – increases risk of bleeding
• Abdominal pain
• Loss of appetite
• Mouth sores
• Numbness or tingling of hands and/or feet
• Swelling of the ankles and/or feet
• Eye irritation
• Difficulty breathing
• Joint and muscle pain
• Bone pain
• Chest pain
• Back pain
• Difficulty sleeping
• Blood clots
• Excessive sleepiness
• Loss of balance
• Darkening of the skin
• Abnormalities in taste
• Abnormalities in nails
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Patients may wish to try to reduce irritation to the palms of the hands and soles of the feet to reduce the severity and/or incidence of hand-foot syndrome. Extreme heat, cold and/or friction should be kept to a minimum.
• Keep palms of hands and soles of feet moisturized. Patients should speak with their physician about which products they should use.
• If possible, avoid large crowds or persons who are sick or not feeling well, as this drug may leave patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Avoid contact lenses if your eyes are dry or irritated.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• For mouth sores, patients should rinse their mouths three times a day with a salt and soda solution (8oz of water mixed with ½ to 1 tsp of baking soda and/or ½ to 1 tsp of salt) and brush their teeth with a soft toothbrush to help prevent development of mouth sores.
• Eat small, frequent meals to help alleviate nausea.
• Maintain adequate hydration. Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day).
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should inform their physician if they are taking warfarin or anticoagulant medications.
• Patients should inform their physician if they are taking phenytoin
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past. Patients should inform their phyisician if they are allergic to 5-fluorouracil (5-FU).
• Patients should not dissolve, crush or chew capecitabine tablets.
• Patients taking antacids should avoid antacids within 2 hours before or after a capecitabine dose.
• If patients miss a dose, they should not double up on the subsequent dose, but should call a healthcare provider.
• Patients should take capecitabine within 30 minutes following a meal.
• If an oral dose is missed, do not double up on doses. Patients should contact their doctor in this event.
• Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.
• Patients may experience dizziness, visual changes, confusion or drowsiness. Avoid driving or engaging in activities requiring mental alertness until the response to the drug is known.
When should patients notify their physician?
• Sore throat
• Signs of infection (redness, pus, swelling, tenderness)
• Flu-like symptoms
• Excessive and persistent fatigue
• Persistent nausea and vomiting or stomach pain
• Severe or prolonged diarrhea
• Unexplained bleeding (nosebleeds, blood in urine, black tarry stools, bruising, etc.)
• Severe peeling, pain, rash of palms of hands or soles of feet
• Mouth sores
• Prolonged constipation
• Difficulty breathing
• Swelling, redness or pain of one extremity
• Yellowing of skin or eyes
• Seizures, muscle spasms
• Chest pain or palpitations
• Visual changes
• Excessive sleepiness
• Loss of balance
• Severe peeling, pain, swelling, or redness of the palms of the hands or the soles of the feet
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. Click here to view the package insert
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