Ecansya (previously Capecitabine Krka)

Authorised

This medicine is authorised for use in the European Union

capecitabine

Overview

Ecansya is a cancer medicine that is used to treat:

• colon (large bowel) cancer. Ecansya is used on its own or with other cancer medicines in patients who have had surgery for stage III or Dukes’ stage C colon cancer;
• metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body). Ecansya is used on its own or with other cancer medicines;
• advanced gastric (stomach) cancer. Ecansya is used with other cancer medicines, including a platinum-containing cancer medicine such as cisplatin;
• locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body). Ecansya is used with docetaxel (another cancer medicine) after treatment with anthracyclines (another type of cancer medicine) has failed. It can also be used on its own when treatment with both anthracyclines and taxanes (another type of cancer medicine) has failed or when further treatment with anthracyclines is not suitable for the patient.

Ecansya is a ‘generic’ and a ‘hybrid’ medicine. This means that it is similar to a ‘reference medicine’, but it contains capecitabine at a new strength in addition to existing strengths. While the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Ecansya is also available as 300 mg tablets. 

Ecansya contains the active substance capecitabine.

How is Ecansya used?

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.

How does Ecansya work?

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.

How has Ecansya been studied?

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.

What are the benefits and risks of Ecansya?

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.

Why is Ecansya authorised in the EU?

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.

What measures are being taken to ensure the safe and effective use of Ecansya?

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.

Other information about Ecansya

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

Ecansya : EPAR - Medicine overview

Reference Number: EMA/374044/2020

Product information

Ecansya : EPAR - Product Information

Ecansya : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ecansya (previously Capecitabine Krka)
• Active substance:
  capecitabine
• International non-proprietary name (INN) or common name:
  capecitabine
• Therapeutic area (MeSH):
  • Colonic Neoplasms
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Stomach Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01BC06

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.

Ecansya is indicated for the treatment of metastatic colorectal cancer.

Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.

Ecansya in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Ecansya is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Authorisation details

• EMA product number:
  EMEA/H/C/002605
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Krka, d.d., Novo mesto

  Šmarješka cesta 6; 8501 Novo mesto; Slovenia

• Marketing authorisation issued:
  20/04/2012
• Revision:
  16

Assessment history

Changes since initial authorisation of medicine

Ecansya : EPAR - Procedural steps taken and scientific information after authorisation

Ecansya-H-C-PSUSA-00000531-202404 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/151502/2025

Ecansya : EPAR - Scientific conclusions

Ecansya-H-C-2605-A31-0023 : EPAR - Assessment Report - Article 31

Reference Number: EMA/274404/2020

Ecansya-H-C-PSUSA-00000531-201804 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/455409/2019

Initial marketing authorisation documents

Capecitabine Krka : EPAR - Public assessment report

AdoptedReference Number: EMA/199988/2012

CHMP summary of positive opinion for Capecitabine Krka

AdoptedReference Number: EMA/CHMP/106716/2012