Ecansya (previously Capecitabine Krka)

Ecansya should only be prescribed by a doctor who is qualified in the use of cancer medicines.

Before starting treatment, it is recommended that patients are tested to check that they have a working dihydropyrimidine dehydrogenase (DPD) enzyme.

Ecansya is available as tablets (150, 300 and 500 mg). The dose depends on the patient’s height and weight and the type of cancer being treated. Ecansya tablets should be taken within 30 minutes after a meal. The tablets are given twice daily for 14 days followed by a 7-day gap before the next course.

Treatment is continued for six months after colon surgery. For other types of cancer, treatment is stopped if the disease gets worse or the side effects are unacceptable. Doses need to be adjusted for patients with liver or kidney disease and for patients who develop certain side effects. For patients with partial DPD deficiency, a lower starting dose may be considered.

For more information about using Ecansya, see the package leaflet or contact your doctor or pharmacist.

The active substance in Ecansya, capecitabine, is a cytotoxic medicine (a medicine that kills rapidly dividing cells such as cancer cells) that belongs to the group ‘anti-metabolites’. Capecitabine is converted to the medicine fluorouracil in the body, but more is converted in tumour cells than in normal tissues.

Fluorouracil is very similar to pyrimidine. Pyrimidine is part of the genetic material of cells (DNA and RNA). In the body, fluorouracil takes the place of pyrimidine and interferes with the enzymes involved in making new DNA. As a result, it stops the growth of tumour cells and eventually kills them.

The European Medicines Agency concluded that, in accordance with EU requirements, Ecansya has been shown to have comparable quality and to be bioequivalent to Xeloda. Therefore, the Agency’s view was that, as for Xeloda, the benefits of Ecansya outweigh the identified risks and it can therefore be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ecansya have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Ecansya are continuously monitored. Side effects reported with Ecansya are carefully evaluated and any necessary action taken to protect patients.

Ecansya received a marketing authorisation valid throughout the European Union on 19 November 2012.

Because Ecansya is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Xeloda, and do not need to be repeated for Ecansya.

As for every medicine, the company provided studies on the quality of Ecansya. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.