What is Capecitabine SUN - Capecitabine and what is it used for?
Capecitabine SUN is a cancer medicine that contains the active substance capecitabine . It is used for the treatment of:
- colon cancer (large intestine). Capecitabine SUN is used in combination or in the absence of other anticancer drugs in patients undergoing surgery for "stage III" or "stage C Dukes" of colon cancer;
- metastatic colorectal cancer (cancer of the large intestine spread to other parts of the body). Capecitabine SUN is indicated in combination with other anticancer drugs or as monotherapy;
- advanced gastric (stomach) carcinoma. Capecitabine SUN is indicated in combination with other anticancer drugs, 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 SUN is indicated in combination with docetaxel (another anticancer medicine) after the negative treatment with anthracycline (another type of anticancer medicine). 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.
Capecitabine SUN is a "generic medicine". This means that Capecitabine SUN is similar to a 'reference medicine' already authorized in the European Union (EU) called Xeloda. For more information on generic medicines, see the questions and answers by clicking here.
How is Capecitabine SUN - Capecitabine used?
Capecitabine SUN is available as tablets (150 and 500 mg). It can only be obtained by prescription and must be prescribed by a doctor experienced in the use of anticancer drugs. Capecitabine SUN is taken twice a day in doses between 625 and 1 250 mg per square meter of body surface area (calculated based on the patient's height and weight). The dose depends on the type of tumor treated. Your doctor will calculate the number of 150 mg and 500 mg tablets that you will need to take. Capecitabine SUN 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 SUN - Capecitabine work?
The active substance in Capecitabine SUN, capecitabine, is a cytotoxic medicine (a medicine that kills cells that divide, such as cancer cells) belonging to the "antimetabolites" group. Capecitabine is a prodrug converted into 5-fluorouracil (5-FU) in the body, mainly in cancer cells. It is taken in tablet form, whereas 5-FU should normally be 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 the enzymes involved in the synthesis of the new DNA. In this way it inhibits the growth of tumor cells until it is destroyed.
How has Capecitabine SUN - Capecitabine been studied?
Because Capecitabine SUN is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence 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 SUN - Capecitabine?
Because Capecitabine SUN is a generic medicine and 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 SUN - Capecitabine been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Capecitabine SUN 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 to approve the use of Capecitabine SUN in the EU.
What measures are being taken to ensure the safe and effective use of Capecitabine SUN - Capecitabine?
A risk management plan has been developed to ensure that Capecitabine SUN is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Capecitabine SUN, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information on Capecitabine SUN - Capecitabine
On 21 June 2013, the European Commission issued a marketing authorization for Capecitabine SUN, valid throughout the European Union.
For more information on Capecitabine SUN 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: 06-2013
