ABIRATERONE-TEVA

What it is

ABIRATERONE-TEVA contains 125 mg abiraterone acetate tablets in combination with 4 mg methylprednisolone tablets. The product contains lactose and sulfites as excipients.

Approved indications

ABIRATERONE-TEVA 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 in combination with methylprednisolone. For metastatic hormone sensitive prostate cancer, the recommended dose of methylprednisolone is 4 mg administered once daily. For metastatic castration resistant prostate cancer, the recommended dose of methylprednisolone is 4 mg administered twice daily. ABIRATERONE-TEVA tablets can be taken with or without food.

Key safety warnings

ABIRATERONE-TEVA may cause hypertension, hypokalaemia and fluid retention as a consequence of increased mineralocorticoid levels. Co-administration of a corticosteroid suppresses adrenocorticotropic hormone drive, resulting in a reduction in the incidence and severity of these adverse reactions. Before treatment with ABIRATERONE-TEVA, hypertension must be controlled and hypokalaemia must be corrected. Marked increases in liver enzymes leading to drug discontinuation or dosage modification have occurred in controlled clinical studies. Very rarely, hepatitis fulminant and hepatic failure has been seen. Serum transaminases and bilirubin should be measured prior to starting treatment, every two weeks for the first three months of treatment and monthly thereafter. Methylprednisolone suppresses the immune system and increases the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, and mask some signs of infection. In a randomised clinical trial, the addition of radium 223 dichloride to abiraterone acetate plus corticosteroid showed an increase in mortality and an increased rate of fracture. Radium 223 dichloride is not recommended for use in combination with ABIRATERONE-TEVA.

Contraindications

Abiraterone acetate is contraindicated in women who are or may potentially be pregnant. Abiraterone acetate is contraindicated in patients with severe hepatic impairment. Abiraterone acetate is contraindicated in combination with radium 223 dichloride. Known hypersensitivity to abiraterone acetate, methylprednisolone or any excipient in the formulation is contraindicated.

Regulatory history

ABIRATERONE-TEVA abiraterone acetate 250 mg was first listed on the ARTG on 26 September 2023, with a subsequent listing of the 500 mg tablet formulation on 27 September 2023.