Abiraterone Krka
Authorised
This medicine is authorised for use in the European Union
abiraterone acetate
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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):
- when the cancer is newly diagnosed, high risk and sensitive to hormones; Abiraterone Krka is then used in combination with a treatment called androgen deprivation therapy;
- when medical castration (using medicines to stop the production of male hormones) with androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines);
- when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work.
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.
Product information
Latest procedure affecting product information:
N/0007
28/01/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- 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
Pharmacotherapeutic group
Endocrine therapyTherapeutic indication
Abiraterone Krka is indicated with prednisone or prednisolone for:
- the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)
- the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)
- the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
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