Human medicines European public assessment report (EPAR): Abiraterone Krka, abiraterone acetate, Date of authorisation: 24/06/2021, Revision: 3, Status: Authorised
Abiraterone Krka is a cancer medicine used to treat men with metastatic prostate cancer. This is cancer that affects the prostate gland (a gland of the male reproductive system). It is used when the cancer has spread to other parts of the body (metastatic).
Abiraterone Krka is used together with prednisone or prednisolone (anti-inflammatory medicines):
Abiraterone Krka contains the active substance abiraterone acetate and is a ‘generic medicine’. This means that Abiraterone Krka contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Zytiga.
Abiraterone Krka is available as tablets and can only be obtained with a prescription. The recommended dose is 1,000 mg taken once a day on an empty stomach. This means that the patient should wait at least 2 hours after eating before taking the medicine and must not eat for at least 1 hour after taking the medicine. If patients develop liver problems, treatment should be stopped. Treatment may be resumed at a reduced dose if liver function returns to normal.
For more information about using Abiraterone Krka, see the package leaflet or contact your doctor or pharmacist.
The active substance in Abiraterone Krka, abiraterone acetate, is changed in the body to abiraterone which stops the body producing testosterone, a male hormone. Abiraterone does this by blocking an enzyme called CYP17 found in the testes and elsewhere in the body. Because the cancer needs a supply of testosterone to survive and grow, by reducing the production of testosterone, Abiraterone Krka may slow the growth of the prostate cancer.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zytiga, and do not need to be repeated for Abiraterone Krka.
As for every medicine, the company provided studies on the quality of Abiraterone Krka. 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.
Because Abiraterone Krka 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.
The European Medicines Agency concluded that, in accordance with EU requirements, Abiraterone Krka has been shown to have comparable quality and to be bioequivalent to Zytiga. Therefore, the Agency’s view was that, as for Zytiga, the benefits of Abiraterone Krka outweigh the identified risks and it can 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 Abiraterone Krka have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Abiraterone Krka are continuously monitored. Side effects reported with Abiraterone Krka are carefully evaluated and any necessary action taken to protect patients.
Abiraterone Krka received a marketing authorisation valid throughout the EU on 24 June 2021.
N/0007
28/01/2025
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Product information documents contain:
Name of medicine
Abiraterone Krka
Active substance
abiraterone acetate
International non-proprietary name (INN) or common name
abiraterone acetate
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BX03
Endocrine therapy
Abiraterone Krka is indicated with prednisone or prednisolone for:
