How does it work?
Xeloda tablets contain the active ingredient capecitabine, which is a type of chemotherapy medicine for cancer known as a 'cytotoxic antimetabolite'. It is taken by mouth and is converted inside cancer cells to 5-fluorouracil (5-FU), which is the active form of the medicine.
The conversion of capecitabine to 5-FU is carried out by several compounds within the body that are called enzymes. The enzyme responsible for the final step is found mostly in tumour tissues (although it is also found in other tissues in the body). This means that higher concentrations of the active 5-FU are produced within the tumour tissues, rather than other healthy areas of the body. The medicine is said to be 'targeted' against the cancerous cells.
Cancers form when cells within the body multiply abnormally and uncontrollably. These cells spread, destroying nearby tissues. 5-FU works by stopping the cancer cells from multiplying. It does this by inhibiting the production of the cells' genetic material, DNA and RNA. Both DNA and RNA are needed for growth and multiplication of cells. 5-FU causes a deficiency of DNA and RNA in the cancer cells, and this causes the cells to grow in an unbalanced way, resulting in the death of the cells.
5-FU can also affect normal, healthy cells, particularly those that multiply quickly, such as blood cells. However, because the capecitabine is mostly converted to 5-FU only in the cancer cells, it means that side effects on normal healthy cells are less with this medicine than with traditional 'non-targeted' 5-FU given via a drip.
The most important side effect is on the bone marrow where blood cells are made. 5-FU can decrease the production of blood cells, leaving people susceptible to infection. Regular blood tests are therefore needed to monitor levels of blood cells.
What is it used for?
- Cancer of the large bowel and rectum that has spread to other parts of the body (metastatic colorectal cancer).
- To improve survival following surgery for stage III (Dukes' stage C) colon cancer.
- Advanced stomach cancer (in combination with platinum-based chemotherapy).
- Breast cancer that is locally advanced or has spread to other areas of the body (metastatic breast cancer).
For breast cancer, capecitabine is used as second-line treatment when previous chemotherapy has been unsuccessful. It is used either in combination with another anti-cancer medicine called docetaxol, (when previous chemotherapy included an anthracycline medicine such as doxorubicin), or on its own (when previous chemotherapy included a taxane and an anthracycline, or where further anthracycline treatment is not indicated).
How do I take it?
- Xeloda tablets are usually taken twice a day (morning and evening). The tablets should be swallowed whole with water within 30 minutes after eating a meal.
- The dose prescribed and the number of treatment cycles you will need depends on the type and stage of cancer that is being treated, what other treatments you are having, how well you respond to the treatments and what side effects you experience. It is important to follow the instructions given by your doctor.
- You will usually be asked to take this medicine twice a day for 14 days and then have a 7 day break from treatment. This 21 day period is one treatment cycle. However, if you are taking this medicine in combination with other treatments you may be asked to take this medicine twice a day continuously without a break. Follow the instructions given by your specialist.
- If you forget to take a dose at your usual time, skip the missed dose and just take your next scheduled dose as normal. Do not take the missed dose at all and do not double your next dose. Instead, continue with your regular dosing schedule and let your doctor know you missed a dose.
- This medicine may cause fatigue and dizziness. You should take care when performing potentially hazardous activites, such as driving or operating machinery, until you know how this medicine affects you and are sure you can perform such activities safely.
- Chemotherapy medicines including this one can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you will need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
- Side effects from this medicine can become severe, so it is important that you always contact your doctor immediately if you start to experience a side effect. Your doctor may instruct you to decrease your dose and/or temporarily stop taking this medicine as this can help avoid a side effect becoming severe. Stop taking this medicine immediately and contact your doctor if any of the following symptoms occur:
- if you have an increase of more than 4 bowel movements compared to your normal bowel movements each day, or any diarrhoea at night
- if you vomit more than once in a 24-hour time period
- if you lose your appetite, and the amount of food you eat each day is much less than usual
- if you have pain, redness, swelling or sores in your mouth and/or throat
- if you have pain, swelling, redness or tingling of your hands and/or feet
- if you have a temperature of 38°C or greater or any other signs of infection
- if you get chest pain, especially if it occurs during exercise.
- This medicine may be harmful to an unborn baby, and for this reason you should use effective contraception to avoid getting pregnant or fathering a child during treatment. You should continue to use contraception to prevent pregnancy for at least a few months after stopping this medicine; discuss this with your doctor. Women should consult their doctor immediately if they get pregnant during treatment.
- Your ability to get pregnant or father a child may be affected by treatment with this medicine. It is important to discuss fertility with your doctor before starting treatment.
Use with caution in
- People over 60 years of age.
- Decreased kidney function.
- Decreased liver function.
- People with disease affecting the brain or nervous system.
- People with a history of heart disease such as angina or irregular heartbeats (arrhythmias).
- People with disturbances in the levels of electrolytes (in particular calcium) in their blood.
- Diabetes mellitus.
- People with diarrhoea.
Not to be used in
- People who are allergic to fluorouracil.
- People with a history of severe and unexpected reactions to fluoropyrimidine therapy such as fluorouracil.
- People with a deficiency of an enzyme in the body called dihydropyrimidine dehydrogenase (DPD). This is a rare condition present from birth that is not usually associated with health problems unless you receive certain medicines. If you have an unrecognised DPD deficiency and take Xeloda, you may experience severe forms of the side effects.
- People with very low numbers of platelets in their blood (thrombocytopenia).
- People with very low numbers of white blood cells in their blood (leucopenia or neutropenia).
- Severely decreased liver function.
- Severely decreased kidney function.
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Xeloda tablets contain lactose).
- Children and adolescents under 18 years of age.
- People who have been treated in the last four weeks with brivudine or sorivudine for herpes zoster (chickenpox or shingles).
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine should not be used during pregnancy as it is likely to be harmful to a developing baby. Women who could get pregnant should use effective contraception to prevent pregnancy, and men should use effective contraception to prevent fathering a child, both during treatment, and for at least a few months after treatment is finished. Seek further medical advice from your doctor.
- It is not known if this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed. Seek further medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Very common (affect more than 1 in 10 people)
- Loss of appetite.
- Diarrhoea (see warning section above).
- Feeling sick or vomiting.
- Abdominal pain.
- Inflammation of the lining of the mouth, causing a sore mouth or ulcers (stomatitis).
- Painful redness, swelling, blistering or ulceration of the palms and soles (hand-foot syndrome or palmar-plantar erythrodysaesthesia) - see warning section above.
- Feeling weak or tired.
Common (affect between 1 in 10 and 1 in 100 people)
- Decreased numbers of white blood cells in the blood (neutropenia) and an increased risk of getting infections - see warning section above.
- Decreased numbers of red blood cells in the blood (anaemia).
- Weight loss.
- Change in taste.
- Pins and needles sensations (paraesthesia).
- Difficulty sleeping (insomnia).
- Watery eyes, eye irritation or conjunctivitis.
- Shortness of breath, cough.
- Runny nose, nosebleeds.
- Dry mouth.
- Indigestion or wind.
- Bleeding in the gut.
- Hair loss (alopecia).
- Skin reactions such as rash, itching, dry skin, red skin or changes in pigmentation.
- Chest pain (see warning section above).
- Fever (high temperature).
- Swollen ankles due to fluid retention.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Decreased numbers of platelets in the blood (thrombocytopenia) and prolonged bleeding time - see warning section above.
- Difficulty swallowing.
- Confusion, memory or speech problems.
- Lumps under the skin (lipoma).
- Double or blurred vision.
- Fast or irregular heartbeats or awareness of your heartbeat (palpitations).
- Increased or decreased blood pressure.
- Hot flushes, cold extremities.
- Abnormal blood clots in the blood vessels (deep vein thrombosis or pulmonary embolism).
- Yellowing of the skin and whites of the eyes (jaundice).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
Fluorouracil is broken down in the body by an enzyme called dihydropyrimidine dehydrogenase (DPD). The action of DPD is inhibited by medicines known as antiviral nucleosides, such as brivudine and sorivudine. These medicines may increase the risk of side effects from fluorouracil and should not be used in people treated with Xeloda, or within four weeks of treatment with Xeloda.
This medicine may enhance the anti-blood-clotting effect of the anticoagulant warfarin. Your doctor may need to monitor your blood clotting time (INR) more frequently if you are taking warfarin in combination with Xeloda.
This medicine may increase the amount of the anticonvulsant medicine phenytoin in the blood and could therefore increase the chance of its side effects. If you are taking phenytoin in combination with Xeloda your doctor may need to do some extra monitoring.
Vaccines may be less effective in people receiving chemotherapy. This is because chemotherapy medicines reduce the activity of the immune system and can prevent the body forming adequate antibodies. Live vaccines should be postponed until at least six months after finishing chemotherapy because they may cause infection. Live vaccines include the following: oral polio; rubella; measles, mumps and rubella (MMR); BCG; chickenpox; yellow fever and oral typhoid vaccines.
There may be an increased risk of side effects if this medicine is used in combination with interferon alfa or with folate supplements such as folinic acid. A lower dose of Xeloda may be needed if you are taking one of these as well.
There may be an increased risk of side effects if this medicine is used in combination with other medicines which can also suppress bone marrow function and affect blood cell counts, for example other chemotherapy medicines, or the antipsychotic clozapine.
Allopurinol may make this medicine less effective and should be avoided while you are having treatment with Xeloda.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain capecitabine as the active ingredient.