ANDRIGA-10

What it is

ANDRIGA-10 is a composite blister pack containing abiraterone acetate 1000 mg (as two 500 mg film-coated tablets) and prednisolone 10 mg (as two 5 mg tablets). The abiraterone film-coated tablets each contain 500 mg abiraterone acetate. Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that selectively inhibits the enzyme 17α hydroxylase/C17,20-lyase (CYP17).

Approved indications —

Patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT). — Patients with mCRPC who have received prior chemotherapy containing a taxane.

Dosing overview

The recommended dosage of abiraterone acetate is 1 g (two 500 mg film-coated tablets) as a single daily dose that must not be taken with food. Abiraterone acetate must be taken at least two hours after eating and food must not be eaten for at least one hour after taking abiraterone acetate. For metastatic castration-resistant prostate cancer (mCRPC), abiraterone acetate is used with 10 mg prednisolone daily (ANDRIGA-10, which contains abiraterone acetate 1000 mg as two 500 mg film-coated tablets and prednisolone 10 mg as two 5 mg tablets).

Key safety warnings

Abiraterone should be used with caution in patients with a history of cardiovascular disease. The safety of abiraterone in patients with left ventricular ejection fraction (LVEF) less than 50% or New York Heart Association Class III or IV heart failure was not established. Before treatment with abiraterone, hypertension must be controlled and hypokalaemia must be corrected. Abiraterone may cause hypertension, hypokalaemia and fluid retention as a consequence of increased mineralocorticoid levels. Blood pressure, serum potassium and fluid retention should be monitored at least monthly. Marked increases in liver enzymes leading to drug discontinuation or dosage modification occurred in controlled clinical studies. Very rarely hepatitis fulminant and hepatic failure has been seen. Serum transaminase and bilirubin levels should be measured prior to starting treatment with abiraterone, every two weeks for the first three months of treatment, and monthly thereafter. Isolated cases of hypoglycaemia have been reported when abiraterone acetate plus prednisone/prednisolone was administered to patients with pre-existing diabetes receiving pioglitazone or repaglinide. Blood glucose should be monitored in patients with diabetes.

Contraindications

Abiraterone acetate is contraindicated in women who are or may potentially be pregnant and in patients with severe hepatic impairment (Child Pugh Class C). Abiraterone acetate plus prednisone/prednisolone is contraindicated in combination with radium 223 dichloride (XOFIGO). Prednisolone is contraindicated in uncontrolled infections and in patients with known hypersensitivity to prednisolone or any of the excipients in the tablet.

PBS listing

ANDRIGA-10 was recommended by PBAC in July 2025 for castration resistant metastatic carcinoma of the prostate (mCRPC).

Regulatory history

ANDRIGA-10 was first listed on the ARTG on 7 July 2025 under ARTG registration 437511. In July 2025, the PBAC recommended ANDRIGA-10 for mCRPC, with the restriction that it be cost-effective if no more than the least costly alternative therapy for this indication.