drugs

Capecitabine Krka - Capecitabine

What is Capecitabine Krka - Capecitabine?

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

Capecitabine Krka is a "generic hybrid medicine". This means that Capecitabine Krka 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 in 150 and 500 mg tablets, Capecitabine Krka is also available as 300 mg tablets.

What is Capecitabine Krka - Capecitabine used for?

Capecitabine Krka 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 Krka - Capecitabine used?

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

Capecitabine Krka is given twice a day in doses of between 625 and 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 Krka 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 Krka - Capecitabine work?

The active substance in Capecitabine Krka, 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 Krka - 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 Krka - Capecitabine?

Because Capecitabine Krka 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 Krka - Capecitabine been approved?

The CHMP concluded that, in accordance with EU requirements, Capecitabine Krka 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 Krka.

More information on Capecitabine Krka - Capecitabine

On 20 April 2012, the European Commission issued a marketing authorization for Capecitabine Krka, valid throughout the European Union.

For more information on Capecitabine Krka therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Last update of this summary: 03-2012.