Abiranio 250 mg Tabletten - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Summary of risk management plan for Abiraterone 250 mg tablets and Abiraterone 500 mg film-coated tablets.

This is a summary of the risk management plan (RMP) for Abiraterone 250 mg tablets and Abiraterone 500 mg film-coated tablets. The RMP details important risks of Abiraterone 250 mg tablets / Abiraterone 500 mg film-coated tablets, how these risks can be minimised, and how more information will be obtained about Abiraterone 250 mg tablets/ Abiraterone 500 mg film-coated tablets risks and uncertainties (missing information).

Abiraterone 250 mg tablets and Abiraterone 500 mg film-coated tablets summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Abiraterone 250 mg Tablets / Abiraterone 500 mg film-coated tablets should be used.

• I. The medicine and what it is used for

Abiraterone 250 mg tablets/ Abiraterone 500 mg film-coated tablets is indicated with prednisone or prednisolone for i) the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT), ii) 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, and iii) the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen (see SmPC for the full indication). It contains abiraterone acetate as the active substance and it is given by mouth.

• II. Risks associated with the medicine and activities to minimise or further characterise the risks

Important risks of Abiraterone 250 mg tablets and Abiraterone 500 mg film-coated tablets, together with measures to minimise such risks and the proposed studies for learning more about Abiraterone250 mg tablets/ Abiraterone 500 mg film-coated tablets risks, are outlined below.

Measures to minimise the risks identified for medicinal products can be:

• Specific information, such as warnings, precautions, and advice on correct use, in the package leaflet and SmPC addressed to patients and healthcare professionals;
• Important advice on the medicine’s pac­kaging;
• The authorised pack size — the amount of medicine in a pack is chosen so to ensure that the medicine is used correctly;
• The medicine’s legal status — the way a medicine is supplied to the patient (e.g. with or without prescription) can help to minimise its risks.

Together, these measures constitute routine risk minimisation measures.

In addition to these measures, information about adverse reactions is collected continuously and regularly analysed so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.

If important information that may affect the safe use of Abiraterone is not yet available, it is listed under ‘missing information’ below.

II.A List of important risks and missing information

Important risks of Abiraterone 250 mg tablets and Abiraterone 500 mg film-coated tablets are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely taken. Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of Abiraterone 250 mg tablets and Abiraterone 500 mg film-coated tablets. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected (e.g. on the long-term use of the medicine).

List of important risks and missing information
Important identified risks	Hepatotoxicity Cardiac disorder Osteoporosis including osteoporosis-related fractures Rhabdomyolysis/My­opathy Allergic alveolitis Increased exposure with food
Important potential risks	Anaemia Cataract Drug-induced interaction (CYP2D6)

List of important risks and missing information

Missing information

Use in patients with active or symptomatic viral hepatitis Use in patients with moderate/severe hepatic impairment and chronic liver disease Use in patients with severe renal impairment Use in patients with heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease or cardiac ejection fraction measurement of <50%

II.B Summary of important risks

The safety information in the proposed Product Information is aligned to the reference medicinal product.

II.C Post-authorisation development plan

II.C.1 Studies which are conditions of the marketing authorisation

There are no studies which are conditions of the marketing authorisation or specific obligation of abiraterone.

II.C.2 Other studies in post-authorisation development plan

There are no studies required for Abiraterone 250 mg tablets and Abiraterone 500 mg film-coated tablets.

EU Risk Management Plan for abiraterone

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