Abiraterone is a cytochrome P450 17A1 inhibitor. It is available as tablets for oral use. MedsAcross supplies Abiraterone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). metastatic high-risk castration-sensitive prostate cancer (CSPC).
Source: US FDA prescribing information
Abiraterone acetate (ZYTIGA) is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis. CYP17 catalyzes two sequential reactions: 1) the conversion of pregnenolone and progesterone to their 17α-hydroxy derivatives by 17α-hydroxylase activity and 2) the subsequent formation of dehydroepiandrosterone (DHEA) and androstenedione, respectively, by C17, 20 lyase activity. DHEA and androstenedione are androgens and are precursors of testosterone. Inhibition of CYP17 by abiraterone can also result in increased mineralocorticoid production by the adrenals. Androgen sensitive prostatic carcinoma responds to treatment that decreases androgen levels.
Source: US FDA prescribing information
Metastatic castration-resistant prostate cancer: ZYTIGA 1,000 mg orally once daily with prednisone 5 mg orally twice daily. Metastatic castration-sensitive prostate cancer: ZYTIGA 1,000 mg orally once daily with prednisone 5 mg orally once daily. Patients receiving ZYTIGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ZYTIGA tablets must be taken as a single dose once daily on an empty stomach. Do not eat food 2 hours before and 1 hour after taking ZYTIGA. The tablets must be swallowed whole with water. Do not crush or chew tablets. Dose Modification: For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the ZYTIGA starting dose to 250 mg once daily. For patients who develop hepatotoxicity during treatment, hold ZYTIGA until recovery. Retreatment may be initiated at a reduced dose.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Mineralocorticoid excess: Closely monitor patients with cardiovascular disease. Control hypertension and correct hypokalemia before treatment. Monitor blood pressure, serum potassium and symptoms of fluid retention at least monthly. Adrenocortical insufficiency: Monitor for symptoms and signs of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations. Hepatotoxicity: Can be severe and fatal. Monitor liver function and modify, interrupt, or discontinue ZYTIGA dosing as recommended. Increased fractures and mortality in combination with radium Ra 223 dichloride: Use of ZYTIGA plus prednisone/prednisolone in combination with radium Ra 223 dichloride is not recommended. Embryo-Fetal Toxicity: ZYTIGA can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.
Source: US FDA prescribing information
The following are discussed in more detail in other sections of the labeling: Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess. Adrenocortical Insufficiency. Hepatotoxicity. Increased Fractures and Mortality in Combination with Radium Ra 223 Dichloride. The most common adverse reactions (≥10%) are fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache. The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, and hypokalemia.
Source: US FDA prescribing information
CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during ZYTIGA treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA dosing frequency. CYP2D6 Substrates: Avoid co-administration of ZYTIGA with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate.
Source: US FDA prescribing information
Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted in the range from 15 °C to 30 °C (59 °F to 86 °F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
7 presentations of Abiraterone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Abiraterone 250 mg tabletOralGeneric name | — | US FDA | Available on request |
| Abiraterone 500 mg tabletOralGeneric name | — | US FDA | Available on request |
| Abiraterone 125 mg tabletOralGeneric name | — | US FDA | Available on request |
| Abirtega 250 mg tabletOral | CivicaScript | US FDA | Available on request |
| Yonsa 125 mg tabletOral | Sun Pharmaceutical IndustriesIndia | US FDA | Available on request |
| Zytiga 250 mg tabletOral | Janssen Biotech | US FDA | Available on request |
| Zytiga 500 mg tabletOral | Janssen Biotech | US FDA | Available on request |
3 brand names across 1 markets.
Indian manufacturers are highlighted.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 7 presentations of Abiraterone and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Sun Pharmaceutical Industries.
The catalogue lists 3 brand names for Abiraterone, including Abirtega, Yonsa, Zytiga.
Yes. The US FDA first approved Abiraterone on 28 April 2011, according to Drugs@FDA.
Yes. Abiraterone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Abiraterone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Abiraterone is classified under ATC code L02BX03 (Abiraterone).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.