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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMEA/H/C/002386

EPAR summary for the public

Capecitabine Accord

capecitabine

This is a summary of the European public assessment report (EPAR) for Capecitabine Accord. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Capecitabine Accord.

What is Capecitabine Accord?

Capecitabine Accord is a medicine that contains the active substance capecitabine. It is available as tablets (150, 300 and 500 mg).

Capecitabine Accord is a 'hybrid generic medicine'. This means that it is similar to a 'reference medicine' containing the same active substance, but available at a new strength in addition to existing strengths. While the reference medicine, Xeloda, is available as 150 and 500 mg tables, Capecitabine Accord is also available as 300 mg tablets.

What is Capecitabine Accord used for?

Capecitabine Accord is an anticancer medicine. It is used to treat:

•    colon (large bowel) cancer. Capecitabine Accord is used with or without other anticancer medicines in patients who have had surgery for 'stage III' or 'Dukes' stage C' colon cancer;

•    metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body). Capecitabine Accord is used with or without other anticancer medicines;

•    advanced gastric (stomach) cancer. Capecitabine Accord is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;

•    locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body). Capecitabine Accord is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed. It can also be used

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on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.

The medicine can only be obtained with a prescription.

How is Capecitabine Accord used?

Capecitabine Accord should only be prescribed by a doctor who is qualified in the use of anticancer medicines.

Capecitabine Accord 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, 300 and 500 mg tablets the patient needs to take. Capecitabine Accord 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 Capecitabine Accord work?

The active substance in Capecitabine Accord, 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 Capecitabine Accord been studied?

The company provided data from studies to determine that it is bioequivalent to the reference medicine, Xeloda. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Capecitabine Accord?

Because Capecitabine Accord is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Capecitabine Accord been approved?

The CHMP concluded that, in accordance with EU requirements, Capecitabine Accord has been shown to have comparable quality and to be bioequivalent to Xeloda. Therefore, the CHMP's view was that, as for Xeloda, the benefit outweighs the identified risk. The Committee recommended that Capecitabine Accord be given marketing authorisation.

Capecitabine Accord

Other information about Capecitabine Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Accord on 20 April 2012.

The full EPAR for Capecitabine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Capecitabine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency's website.

This summary was last updated in 03-2012.

Capecitabine Accord

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