ABIRATERONE VIATRIS

What it is

ABIRATERONE DR.REDDY'S is a tablet formulation of abiraterone acetate, available in 250 mg and 500 mg strengths. Abiraterone acetate is converted in the body to abiraterone, an androgen biosynthesis inhibitor that selectively inhibits the enzyme 17a hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in testicular, adrenal and prostatic tumour tissues and is required for androgen biosynthesis.

Approved indications

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

Dosing overview

The recommended dosage of ABIRATERONE DR.REDDY'S is 1 g (four 250 mg tablets or two 500 mg tablets) as a single daily dose that must not be taken with food. The tablets must be taken as a single dose once daily on an empty stomach, at least two hours after eating, and food must not be eaten for at least one hour after taking the medicine. Serum transaminases and bilirubin should be measured prior to starting treatment, every two weeks for the first three months of treatment and monthly thereafter. Blood pressure, serum potassium and fluid retention should be monitored monthly.

Key safety warnings

Abiraterone may cause hypertension, hypokalaemia and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Before treatment with ABIRATERONE DR.REDDY'S, hypertension must be controlled, and hypokalaemia must be corrected. Caution is required in treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalaemia or fluid retention, such as those with heart failure, recent myocardial infarction or ventricular arrhythmia. In postmarketing experience, QT prolongation and Torsades de Pointes have been observed in patients who develop hypokalaemia or have underlying cardiovascular conditions while taking abiraterone. 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 have 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. For patients who develop hepatotoxicity during treatment (alanine aminotransferase or aspartate aminotransferase increases above 5 times the upper limit of normal or bilirubin increases above 3 times the upper limit of normal), treatment should be withheld immediately until liver function tests normalise. In a randomised clinical trial in patients with asymptomatic or mildly symptomatic bone-predominant metastatic castration resistant prostate cancer, the addition of radium 223 dichloride to abiraterone plus prednisolone showed an increase in mortality and an increased rate of fracture. Radium 223 dichloride is not recommended for use in combination with ABIRATERONE DR.REDDY'S plus prednisolone.

Contraindications

ABIRATERONE DR.REDDY'S is contraindicated in women who are or may potentially be pregnant. ABIRATERONE DR.REDDY'S is contraindicated in patients with severe hepatic impairment (Child Pugh Class C). ABIRATERONE DR.REDDY'S plus prednisolone is contraindicated in combination with XOFIGO (radium 223 dichloride).

Regulatory history

ABIRATERONE DR.REDDY'S abiraterone acetate 250 mg tablet was first listed on the ARTG on 2024-11-04, and the 500 mg tablet blister pack formulation was first listed on 2025-02-25.