What is Capecitabine Medac - capecitabine?
Capecitabine Medac is a medicine that contains the active substance capecitabine. It is available as tablets (150, 300 and 500 mg).
Capecitabine Medac is a "generic" and "hybrid" medicine. This means that it is similar to a "reference medicine" but contains capecitabine in a new dosage, in addition to the existing dosages. While the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Capecitabine Medac is also available as 300 mg tablets.
What is Capecitabine Medac - capecitabine used for?
Capecitabine Medac is an anticancer medicine. It is used for the treatment of:
- colon cancer (large intestine). Capecitabine Medac is indicated in combination with other anticancer medicines or as a single agent (in patients) undergoing surgery for "stage III" or "stage C Dukes" colon cancer;
- metastatic colorectal carcinoma (cancer of the large intestine that has spread to other parts of the body). Capecitabine Medac is indicated in combination with other anticancer medicines or as a single agent;
- advanced gastric (stomach) carcinoma. Capecitabine Medac is indicated in combination with other anticancer medicines, including one containing platinum such as cisplatin;
- locally advanced or metastatic breast cancer (ie that has begun to spread to other parts of the body). Capecitabine Medac is indicated in combination with docetaxel (another anticancer medicine) after treatment with anthracycline (another type of anticancer medicine) has failed. It can also be used as a single agent when treatment with anthracycline and taxanes (another type of anticancer medicine) has failed or if it is not indicated to repeat anthracycline therapy.
The medicine can only be obtained with a prescription.
How is Capecitabine Medac - capecitabine used?
Capecitabine Medac should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Capecitabine Medac is taken twice a day in doses between 625 and 1 250 mg per square meter of body surface area (calculated based on the height and weight of the patient). 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 Medac tablets should be swallowed with water within 30 minutes of a meal.
Treatment continues 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 it. Doses need to be adjusted in patients with liver (liver) or kidney disease and in those with certain side effects.
Complete information is available in the summary of product characteristics (included with EPAR).
How does Capecitabine Medac - capecitabine work?
The active substance in Capecitabine Medac, capecitabine, is a cytotoxic medicine (ie a medicine that kills cells that divide, such as cancer cells) belonging to the group of "antimetabolites". Capecitabine is a "prodrug" and in the body it is converted to 5-fluorouracil (5-FU); however its conversion is greater in cancer cells than in healthy tissues. It is taken in tablet form, whereas 5-FU is normally injected.
5-FU is an analogue of pyrimidine, which 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 DNA synthesis. In this way it blocks the growth of tumor cells until it is destroyed.
How has Capecitabine Medac - capecitabine been studied?
The company presented data on capecitabine taken from the scientific literature.
The company conducted a "bioequivalence" study to show that 500 mg of Capecitabine Medac produce the same levels of capecitabine in the blood obtained with 500 mg of Xeloda.
What are the benefits and risks of Capecitabine Medac - capecitabine?
Because Capecitabine Medac contains the same active substance as the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Capecitabine Medac - capecitabine been approved?
The CHMP concluded that, in accordance with EU requirements, Capecitabine Medac 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 Medac.
More information on Capecitabine Medac - capecitabine
On 19 November 2012, the European Commission issued a marketing authorization for Capecitabine Medac, valid throughout the European Union.
For the full EPAR of Capecitabine Medac, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Capecitabine Medac therapy, 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.
Last update of this summary: November 2012.
