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Capecitabine Accord

Active Substance: capecitabine
Common Name: capecitabine
ATC Code: L01BC06
Marketing Authorisation Holder: Accord Healthcare Ltd
Active Substance: capecitabine
Status: Authorised
Authorisation Date: 2012-04-20
Therapeutic Area: Colorectal Neoplasms Colonic Neoplasms Stomach Neoplasms Breast Neoplasms
Pharmacotherapeutic Group: Antineoplastic agents

Therapeutic Indication

Capecitabine Accord is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.

Capecitabine Accord is indicated for the treatment of metastatic colorectal cancer.

Capecitabine Accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.

Capecitabine Accord in combination with docetaxel  is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Capecitabine Accord is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. 

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 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.

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.

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.

Other information about Capecitabine Accord

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

For more information about treatment with Capecitabine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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