Xeloda500 mg film-coated tablets Capecitabine - United Kingdom[英国药品]

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Xeloda500 mg film-coated tablets Capecitabine

2014-02-09 18:52:17 来源: 作者: 【大中小】浏览:336次评论:0条

For doctors

What is it and how is it used?

Xeloda belongs to the group of medicines called "cytostatic agents", which stop the growth of cancer cells. Xeloda contains 500 mg capecitabine, which itself is not a cytostatic agent. Only after being absorbed by the body is it changed into an active anti-cancer agent (more in tumour tissue than in normal tissue).

Xeloda is prescribed by doctors for the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Xeloda is prescribed by doctors to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.

Xeloda may be used either alone or in combination with other agents.

What do you have to consider before using it?

Do not take Xeloda:

Take special care with Xeloda:
Before treatment with Xeloda, make sure your doctor knows if you

Taking other medicines:
Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines. You need to be particularly careful if you are taking any of the following:

Taking Xeloda with food and drink:
You should take Xeloda no later than 30 minutes after meals.

Pregnancy and breast-feeding
Before starting treatment, you must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. You should not take Xeloda if you are pregnant or think you might be. You should not breast-feed if you are taking Xeloda. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:
Xeloda may make you feel dizzy, nauseous or tired. It is therefore possible that Xeloda could affect your ability to drive a car or operate machinery.

Important information about some of the ingredients of Xeloda:
This medicinal product contains anhydrous lactose as an excipient. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Xeloda.

How is it used?

Xeloda tablets should be swallowed with water.

Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Xeloda is based on your body surface area. This is calculated from your height and weight. The usual dose for adults is 1250 mg/m of body surface area taken two times daily (morning and evening). Two examples are provided here: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily. A person whose body weight is 80 kg and height is 1.80 m has a body surface area of 2.00 m and should

Xeloda tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken). This 21 day period is one treatment cycle.

In combination with other agents the usual dose for adults may be less than 1250 mg/m of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period).

Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.

Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose.

If you take more Xeloda than you should, contact your doctor before taking the next dose.

If you forget to take Xeloda: do not take the missed dose at all and do not double the next one. Instead, continue your regular dosing schedule and check with your doctor.

If you stop taking Xeloda:
There are no side-effects caused by stopping treatment with Xeloda. In case you are using coumarin anticoagulants (e.g. Marcumar), stopping Xeloda might require that your doctor adjusts your anticoagulant dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Xeloda can cause side effects, although not everybody gets them.

When Xeloda is used alone, the most common side effects which may affect more than 1 person in 10 are:

These side effects can become severe; therefore, it is important that you always contact your doctor immediately when you start to experience a side effect. Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Xeloda. This will help reduce the likelihood that the side effect continues or becomes severe.

STOP taking Xeloda immediately and contact your doctor if any of these symptoms occur:

If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation. If these side effects continue, however, contact your doctor immediately. Your doctor may instruct you to restart treatment at a lower dose.

Other less common and usually mild side-effects which may affect between 1 person and 10 people in 100 have been seen: decreases in the number of white blood cells or red blood cells, skin rashes, slight hair loss, weariness, fever, weakness, drowsiness, headache, numbness or tingling sensations, taste changes, dizziness, sleeplessness, swelling in the legs, constipation, dehydration, cold sores, inflammation of the nose and throat, chest infection, depression, problems with the eyes, inflammation of the veins (thrombophlebitis), shortness of breath, nose bleeds, cough, runny nose, bleeding from the gut, heartburn, excess wind, dry mouth, skin discolouration, nail disorder, pain in the joints, chest or back and loss of weight.

If you are concerned about these or any other unexpected effect(s), talk to your doctor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children

Do not store above 30°C

Do not use Xeloda after the expiry date which is stated on the outer pack and label.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

Xeloda is a medicine that contains the active substance capecitabine. It is available as peach-coloured tablets (150 and 500 mg).

What is it used for?

Xeloda is an anticancer medicine. It is used to treat:

How is it used?

Xeloda should only be prescribed by a doctor who is qualified in the use of anticancer medicines. Xeloda is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient’s height and weight). The dose depends on the type of cancer being treated. The doctor will calculate the number of 150- and 500-mg tablets the patient needs to take. Xeloda tablets should be swallowed with water within the 30 minutes after a meal. Treatment is continued for six months after colon surgery. For other types of cancer, treatment is stopped if the disease gets worse or the patient cannot tolerate the treatment. Doses need to be adjusted for patients with liver or kidney disease and for patients who develop certain side effects. Full details are available in the Summary of Product Characteristics (also part of the EPAR).

How does it work?

The active substance in Xeloda, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites’. Capecitabine is a ‘prodrug’ that is converted to 5-fluorouracil (5-FU) in the body, but more is converted in tumour cells than in normal tissues. It is taken as tablets, while 5-FU normally needs to be injected. 5-FU is an analogue of pyrimidine. Pyrimidine is part of the genetic material of cells (DNA and RNA). In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA. As a result, it inhibits the growth of tumour cells and eventually kills them.

How has it been studied?

In colon cancer, Xeloda on its own has been compared with the combination of 5-FU and folinic acid (a medicine that enhances the effects of 5-FU) in 1,987 patients who had previously had surgery for their cancer.
In metastatic colorectal cancer, Xeloda taken on its own has been compared with the combination of 5-FU and folinic acid in two studies involving 1,207 patients. Xeloda has also been compared with the combination of 5-FU and folinic acid, both in combination with oxaliplatin (another anticancer medicine), in two studies: the first involved 2,035 patients who had not been treated before, and the second involved 627 patients who had failed previous treatment with irinotecan and a fluoropyrimidine (a group of anticancer medicines that includes 5-FU).
In advanced gastric cancer, Xeloda with cisplatin has been compared with a combination of 5-FU and cisplatin in one study involving 316 patients. The company also presented the results of a published study involving 1,002 patients, which compared the effects of Xeloda and 5-FU, taken in combination with platinum-containing medicines and epirubicin (another anticancer medicine). In locally advanced or metastatic breast cancer, Xeloda with docetaxel has been compared with docetaxel on its own in 511 women. Two smaller studies (238 patients) have also looked at the effectiveness of Xeloda after failure of treatment with taxanes and anthracyclines.
The main measures of effectiveness were the number of patients whose cancer responded to treatment, how long it took for the disease to progress, how long the patients remained disease-free or how long they survived.

What benefits has it shown during the studies?

In colon cancer, Xeloda was also as effective as 5-FU and folinic acid, with about two-thirds of the patients remaining disease-free throughout the 3.8 years of the study.
In metastatic colorectal cancer, Xeloda was as effective as the combination of 5-FU and folinic acid. When taken alone, between 19 and 25% of patients responded to Xeloda, and 12 to 15% responded to the comparator combination. When either Xeloda or 5-FU and folinic acid were taken with oxaliplatin, it took an average of eight months for the disease to get worse in patients who had not been treated before, and five months in patients whose previous treatment had failed.
In advanced gastric cancer, Xeloda with cisplatin was as effective as 5-FU and cisplatin. It took 5.6 months for the disease to get worse in patients taking Xeloda and cisplatin, and 5.0 months in patients receiving 5-FU and cisplatin. The published study showed that patients taking combinations of medicines that included Xeloda survived for a similar length of time as those taking combinations including 5-FU.
In locally advanced or metastatic breast cancer, Xeloda combined with docetaxel was more effective that docetaxel on its own in increasing how long it took for the disease to get worse (186 days compared with 128 days).

What is the risk associated?

The most common side effects with Xeloda (seen in more than 1 patient in 10) are anorexia (loss of appetite), diarrhoea, vomiting, nausea (feeling sick), stomatitis (sores in the mouth), abdominal (tummy) pain, palmar-plantar erythrodysaesthesia syndrome (‘hand-foot syndrome’, a skin reaction with rash and pain on the hands and feet), fatigue (tiredness) and asthenia (weakness). For the full list of all side effects reported with Xeloda, see the Package Leaflet.
Xeloda should not be used in people who may be hypersensitive (allergic) to capecitabine, to any of the other ingredients, or to fluorouracil. Xeloda should also not be used in the following groups:

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Xeloda’s benefits are greater than its risks for:

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Xeloda to Roche Registration Limited on 2 February 2001. The marketing authorisation was renewed on 2 February 2006.

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