Abiraterone
Zytiga · ATC code L02BX03
Also known as: Abirateron · Brand names: Zytiga, Abiral, Abiraterone G.L., Abibam®, Abiranio, Abiratel, Abirateronacetat, Abiraterone Synthon, Abetyl, Abiratex, Abıtıga, Abyga, Arvila, Byretu, Dipon …
- Key facts
- Active substance
- Abiraterone
- ATC code
- L02BX03
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- ZYTIGA 250 mg tablets · ZYTIGA 500 mg film-coated tablets
- Marketing authorisation holder
- Janssen-Cilag International
- Information as of
- 2026-10-27
Key facts
Abiraterone is an androgen biosynthesis inhibitor (CYP17 inhibitor). It is used with prednisone or prednisolone to treat metastatic prostate cancer in adult men.
What it is used for
- Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC), in combination with androgen deprivation therapy (ADT)
- Metastatic castration-resistant prostate cancer (mCRPC) in asymptomatic or mildly symptomatic men after failure of ADT, when chemotherapy is not yet clinically indicated
- mCRPC that has progressed on or after a docetaxel-based chemotherapy regimen
Dosing
- Recommended dose: 1,000 mg once daily (four 250 mg tablets or two 500 mg film-coated tablets), not taken with food
- With 5 mg prednisone or prednisolone daily for mHSPC; with 10 mg daily for mCRPC
- Medical castration with an LHRH analogue continues in patients not surgically castrated
- Hepatotoxicity (ALT/AST above 5 times ULN): withhold immediately; after recovery, re-treatment may be given at a reduced dose of 500 mg once daily
- Severe hepatotoxicity (ALT or AST 20 times ULN): discontinue permanently
- Mild hepatic impairment (Child-Pugh A): no dose adjustment
- Missed dose: resume the following day with the usual daily dose
Contraindications
- Hypersensitivity to the active substance or any excipient
- Women who are or may potentially be pregnant
- Severe hepatic impairment (Child-Pugh C)
- Combination with Ra-223 (with prednisone/prednisolone)
Important warnings
- Hypertension, hypokalaemia, fluid retention and cardiac failure due to mineralocorticoid excess from CYP17 inhibition
- Caution in heart failure, severe or unstable angina, recent myocardial infarction or ventricular arrhythmia
- Serum transaminases before starting, every two weeks for the first three months, then monthly
- Blood pressure, serum potassium and fluid retention monitored monthly
- Grade ≥3 toxicities: withhold until resolved to Grade 1 or baseline
Side effects
- Very common (≥10%): peripheral oedema, hypokalaemia, hypertension, urinary tract infection, increased ALT and/or AST
- Other important reactions: cardiac disorders, hepatotoxicity, fractures, allergic alveolitis
Interactions
- Food significantly increases absorption; must not be taken with food
- Strong CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampicin, phenobarbital, St John's wort) are to be avoided unless there is no therapeutic alternative
- Rifampicin decreased abiraterone AUC by 55%
Pregnancy and breastfeeding
- Not for use in women; contraindicated in women who are or may potentially be pregnant
- A condom is required for sex with a pregnant woman; with a woman of childbearing potential, a condom plus another effective contraceptive method
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Abiraterone Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/005408
- ZytigaJanssen-Cilag International · EMEA/H/C/002321
Source: European Medicines Agency (EMA), product information
Austria
- AbiralGenericon Pharma Gesellschaft M.B.H. · 1 register entry
- Abirateron1a Pharma Gmbh, Bluepharma Indústria Farmacêutica S.A., +pharma Arzneimittel Gmbh, Devatis Gmbh, Zentiva, K.S., Aristo Pharma Gmbh (Art 57), Sandoz Gmbh, Stada Arzneimittel Gmbh, G.L. Pharma Gmbh · 9 register entries
- Abiraterone G.L.G.L. Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Abibam®Dr. Pfleger Arzneimittel Gmbh · 1 register entry
- AbiranioAxunio Pharma Gmbh · 1 register entry
- AbiratelTad Pharma Gmbh · 1 register entry
- Abirateron123 Acurae Pharma Gmbh, Ratiopharm Gmbh, Medical Valley Invest Ab, Glenmark Arzneimittel Gmbh, Abanta Pharma Gmbh, Devatis Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Holsten Pharma Gmbh, Vivanta Generics S.R.O, Zentiva Pharma Gmbh, Amarox Pharma Gmbh, Aristo Pharma Gmbh (Art 57), Acino Ag, Cipla Europe Nv, Hexal Ag, Stadapharm Gmbh, Abdi Farma Gmbh, Betapharm Arzneimittel Gmbh, Qilu Pharma Spain S.L., Sun Pharmaceuticals Germany Gmbh, Aliud Pharma Gmbh · 21 register entries
- AbirateronacetatNovumgen Limited · 1 register entry
- Abiraterone SynthonSynthon Bv · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- AbetylABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- AbiratexGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 1 register entry
- AbıtıgaTEVA PHARMA İLAÇ SAN.VE TİC. A.Ş. · 2 register entries
- AbygaDEVA HOLDİNG A.Ş. · 2 register entries
- ArvilaEİP ECZACIBAŞI İLAÇ PAZARLAMA A.Ş · 1 register entry
- ByretuONKO İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- DiponARVEN İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- ProtigaTEVA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- RatebirWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- ZateronKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
- ZytigaJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Abirateron Eg, Abirateronacetaat Eg (Eurogenerics) Nv, Abirateronacetat Eg (Eurogenerics) Nv, Abiraterone Eugia, Acétate D'abiratérone. Eg (Eurogenerics) Sa, Bixodalan
- Bulgaria
- Абиратерон Msn, Абиратерон Деватис, Абиратерон Зентива, Абиратерон Сандоз, Абиратерон Стада, Абиратерон Тева, Абиратерон Фармасайънс, Абиратерон Хитън, Биратер, Грумабикс, Зилфенан, Татика
- Croatia
- Abirateron Alpha-Medical, Abirateron Devatis, Abirateron Galenika, Abirateron Msn, Abirateron Pharmascience, Abirateron Sandoz, Abirateron Stada, Abirateron Teva, Abirateron Zentiva, Zilfenan
- Cyprus
- Abiraterone Farmoz, Abiraterone Pharmazac, Abiraterone Sandoz, Abiraterone Sapiens, Abiraterone Tecnigen, Remabirat
- Czechia
- Abirateron Ashcure, Abirateron Pharmagen, Abirateron Stada, Abiraterone Abdi, Abiraterone Agmed, Abiraterone Glenmark, Abiraterone Heaton, Abiraterone Msn, Abiraterone Olpha, Abiraterone Richter, Abiraterone Sandoz, Abiraterone Vipharm, Abiraterone Zentiva
- Denmark
- Abirateron "olpha", Abirateron "sandoz", Abirateron Devatis, Abirateron Medac, Abirateron Medical Valley, Abirateron Teva, Abiraterone Ashcure, Abiraterone Glenmark, Abiraterone Qilu, Abiraterone Stada, Abiraterone Vivanta, Abiraterone Zentiva
- Estonia
- Abiraterone G.L. Pharma, Abiraterone Norameda, Abiraterone Olpha, Abiraterone Sandoz, Abiraterone Stada, Abiraterone Zentiva
- Finland
- Abirateron Avansor, Abirateron Devatis, Abirateron Medical Valley, Abirateron Sandoz, Abiraterone Glenmark, Abiraterone Stada, Abiraterone Vivanta
- France
- Abiraterone Acetate Zydus, Abiraterone Arrow, Abiraterone Biogaran, Abiraterone Cristers, Abiraterone Eg, Abiraterone Evolugen, Abiraterone Olpha, Abiraterone Qilu, Abiraterone Sandoz, Abiraterone Synthon, Abiraterone Teva, Abiraterone Zentiva, Abiraterone Zydus, Grumabix, Ibiron
- Greece
- Abinone, Abiprostem, Abiraterone Ariti, Abiraterone Faran, Abiraterone Pharmazac, Abiraterone Rafarm, Abiraterone Sandoz, Abiraterone Stada, Abiraterone Teva, Abiraterone Vocate, Jilidea, Tamoril
- Hungary
- Abaxan, Abirateron Galenika, Abirateron Stada, Abirateron Teva, Abirateron Zentiva, Abiraterone, Grumabix, Tatica
- Iceland
- Abirateron, Abiraterone Accord, Abiraterone Krka, Abiraterone Mylan, Abiraterone Stada, Abiraterone Zentiva, Zytiga
- Ireland
- Abiraterone
- Italy
- Abiraterone Abdi, Abiraterone Aristo, Abiraterone Aurobindo, Abiraterone Eg, Abiraterone Farmoz, Abiraterone Medac, Abiraterone Medical Valley, Abiraterone Olpha, Abiraterone Qilu, Abiraterone Sandoz, Abiraterone Sun, Abiraterone Tecnigen, Abiraterone Zentiva
- Latvia
- Abiraterone G.L. Pharma, Abiraterone Norameda, Abiraterone Olpha, Abiraterone Sandoz, Abiraterone Stada, Abiraterone Teva, Abiraterone Unifarma, Abiraterone Zentiva, Tatica
- Liechtenstein
- Abiraterone Accord, Abiraterone Mylan, Zytiga
- Lithuania
- Abiraterone G.L. Pharma, Abiraterone Norameda, Abiraterone Olpha, Abiraterone Sandoz, Abiraterone Stada, Abiraterone Zentiva, Tatica
- Luxembourg
- Abirateron Eg, Abiraterone Eugia, Abiraterone Synthon
- Malta
- Abiraterone Ashcure, Abiraterone Clonmel, Abiraterone Heaton, Abiraterone Sandoz
- Netherlands
- Abirateron, Abirateronacetaat Amarox, Bixodalan, Tatica
- Norway
- Abirateron Devatis, Abirateron Medical Valley, Abirateron Sandoz, Abirateron Teva, Abiraterone Accord, Abiraterone Glenmark, Abiraterone Krka, Abiraterone Mylan, Abiraterone Qilu, Abiraterone Stada, Abiraterone Vivanta, Abiraterone Zentiva, Zytiga
- Poland
- Abiral, Abirateron Sun, Abiraterone, Grumabix
- Portugal
- Abiraterona Bluepharma, Abiraterona Eugia, Abiraterona Farmoz, Abiraterona Generis, Abiraterona Normon, Abiraterona Sandoz, Abiraterona Tecnigen, Abiraterona Teva, Abiraterona Zentiva, Abiraterone Abdi, Tronyl
- Romania
- Abirateron? Lannacher, Abiraterona Msn, Abirateronä Stada, Abirateronă, Bixodalan, Tatica, Zilfenan
- Slovakia
- Abirateron Msn, Abirateron Pharmagen, Abiraterone Agmed, Abiraterone G.L. Pharma, Abiraterone Glenmark, Abiraterone Heaton, Abiraterone Olpha, Abiraterone Pharmevid, Abiraterone Vipharm, Abiraterone Zentiva, Abiraterón Sandoz, Abiraterón Stada, Tatica
- Slovenia
- Abirateron Galenika, Abirateron Teva, Abiraterone Msn Labs Europe Limited, Bixodalan, Zilfenan
- Spain
- Abiraterona Ashcure, Abiraterona Cipla, Abiraterona Dr. Reddys, Abiraterona Efg Synthon, Abiraterona Eugia, Abiraterona Exeltis, Abiraterona Farmoz, Abiraterona Glenmark, Abiraterona Kern Pharma, Abiraterona Normon, Abiraterona Olpha, Abiraterona Qilu, Abiraterona Sandoz, Abiraterona Stada, Abiraterona Tarbis, Abiraterona Tecnigen, Abiraterona Teva, Abiraterona Tronyl, Abiraterona Vivanta, Abiraterona Zentiva, Abiraterone Sun
- Sweden
- Abirateron Devatis, Abirateron Medical Valley, Abirateron Sandoz, Abirateron Teva, Abiraterone Ashcure, Abiraterone Avansor, Abiraterone Glenmark, Abiraterone Medac, Abiraterone Qilu, Abiraterone Stada, Abiraterone Vivanta, Abiraterone Zentiva
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- European Medicines Agency. Zytiga – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.