ABIRATERONE VIATRIS

What it is

Abiraterone acetate and methylprednisolone is a combination medicine for prostate cancer. The abiraterone acetate component is supplied as 500 mg tablets (four 125 mg tablets administered orally once daily) , paired with methylprednisolone tablets at specified doses depending on the indication.

Approved indications

ABIRATERONE VIATRIS is indicated for the treatment of patients with: — newly diagnosed high-risk metastatic hormone sensitive prostate cancer in combination with androgen deprivation therapy — metastatic advanced prostate cancer (castration resistant prostate cancer) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy — metastatic castration resistant prostate cancer who have received prior chemotherapy containing a taxane

Dosing overview

The recommended dose of abiraterone acetate is 500 mg administered orally once daily . The recommended dose of methylprednisolone for metastatic hormone sensitive prostate cancer is 4 mg administered once daily, whilst for metastatic castration resistant prostate cancer it is 4 mg administered twice daily . ABIRATERONE VIATRIS tablets can be taken with or without food .

Key safety warnings

Abiraterone acetate may cause hypertension, hypokalaemia and fluid retention as a consequence of increased mineralocorticoid levels . Before treatment, hypertension must be controlled and hypokalaemia must be corrected . In postmarketing experience, QT prolongation and Torsades de Pointes have been observed in patients who develop hypokalaemia or have underlying cardiovascular conditions . Marked increases in liver enzymes leading to drug discontinuation or dosage modification occurred in controlled clinical studies, and very rarely hepatitis fulminant and hepatic failure has been seen . Serum transaminase and bilirubin levels should be measured prior to starting treatment, every two weeks for the first three months of treatment, and monthly thereafter . Corticosteroids suppress the immune system and increase the risk of infection with any pathogen; corticosteroid-associated infections can be mild but can be severe and at times fatal, and the rate of infectious complications increases with increasing corticosteroid dosages . Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids .

Contraindications

Abiraterone acetate is contraindicated in women who are or may potentially be pregnant and in patients with severe hepatic impairment . Abiraterone acetate is contraindicated in combination with radium 223 dichloride . ABIRATERONE VIATRIS contains lactose; patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine .

Regulatory history

ABIRATERONE VIATRIS abiraterone acetate 250 mg tablets (ARTG 453789) were first listed on 21 May 2025, and 500 mg film-coated tablets (ARTG 453790) were first listed on 22 May 2025 .