Capecitabine Accord - Capecitabine

What is Capecitabine Accord - Capecitabine?

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 "generic hybrid medicine". This means that Capecitabine Accord is similar to a "reference medicine" that contains the same active ingredient, but is available in a new dosage, in addition to existing ones. While the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Capecitabine Accord is also available as 300 mg tablets.

What is Capecitabine Accord - Capecitabine used for?

Capecitabine Accord is an anticancer medicine indicated for the treatment of:

colon cancer (large intestine). Capecitabine Krka is indicated in combination with other anticancer drugs or as monotherapy (alone) in patients undergoing surgery for "stage III" or "stage C Dukes" colon cancer;
metastatic colorectal cancer (cancer of the large intestine that has spread to other parts of the body). Capecitabine Krka is indicated in combination with other anticancer drugs or as monotherapy;
advanced gastric (stomach) carcinoma. Capecitabine Krka is indicated in combination with other anticancer medicines, including a platinum-containing anticancer drug such as cisplatin;
locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body). Capecitabine Krka is indicated in combination with docetaxel (another type of anticancer medicine) after the negative treatment with anthracycline (another type of anticancer medicine). It can also be used in monotherapy in cases where anthracycline and taxane treatments (other types of anticancer drugs) have not worked or in patients in whom further anthracycline therapy is not suitable.

The medicine can only be obtained with a prescription.

How is Capecitabine Accord - Capecitabine used?

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

Capecitabine Accord is given twice a day in doses ranging from 625 to 1 250 mg per square meter of body surface area (calculated based on the patient's weight and height). The dose depends on the type of tumor treated. The doctor will calculate the number of 150, 300 and 500 mg tablets that the patient should take. Capecitabine Accord tablets should be taken with water within 30 minutes of a meal.

The treatment lasts for six months after colon surgery. For other types of cancer, treatment is suspended if the disease worsens or if the patient does not tolerate treatment. Doses need to be adjusted in patients with liver or kidney diseases and in subjects with certain side effects.

More details are available in the summary of product characteristics (also included with the EPAR).

How does Capecitabine Accord - Capecitabine work?

The active substance in Capecitabine Accord, capecitabine, is a cytotoxic medicine (a drug that can kill cells that divide, such as cancer cells) belonging to the group of "antimetabolites". Capecitabine is a "prodrug" that is converted in the body as 5-fluorouracil (5-FU); however it is converted more in tumor cells than in normal tissues. It is taken as tablets, whereas 5-FU should normally be injected.

5-FU is an analogue of pyrimidine. Pyrimidine is a component of the genetic material of cells (DNA and RNA). In the body, 5-FU replaces pyrimidine and interferes with enzymes involved in the production of new DNA. In this way it inhibits the growth of cancer cells and causes their death.

How has Capecitabine Accord - Capecitabine been studied?

The company presented data from studies to determine the bioequivalence of the medicine to the reference medicine, Xeloda. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.

What are the benefits and risks of Capecitabine Accord - Capecitabine?

Because Capecitabine Accord is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.

Why has Capecitabine Accord - Capecitabine 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 considered that, as in the case of Xeloda, the benefits outweigh the identified risks and recommended the marketing authorization for Capecitabine Accord.