YONSA

What it is

YONSA MPRED contains 125 mg abiraterone acetate tablets (YONSA) and 4 mg methylprednisolone tablets. YONSA tablets can be taken with or without food.

Approved indications

YONSA MPRED is indicated for the treatment of patients with: — 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) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) — mCRPC who have received prior chemotherapy containing a taxane

Dosing overview

The recommended dose of YONSA abiraterone acetate tablets is 500 mg (four 125 mg tablets) administered orally once daily in combination with methylprednisolone. The recommended dose of methylprednisolone for metastatic hormone sensitive prostate cancer is 4 mg administered once daily, and for metastatic castration resistant prostate cancer is 4 mg administered twice daily.

Key safety warnings

Abiraterone acetate may cause hypertension, hypokalaemia and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Before treatment with abiraterone acetate, hypertension must be controlled and hypokalaemia must be corrected. 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 acetate, every two weeks for the first three months of treatment, and monthly thereafter. Corticosteroids, including methylprednisolone, suppress the immune system and increase 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. The rate of infectious complications increases with increasing corticosteroid dosages.

Contraindications

Abiraterone acetate is contraindicated in women who are or may potentially be pregnant, in patients with severe hepatic impairment (Child Pugh Class C), in combination with radium 223 dichloride, and in patients with known hypersensitivity to abiraterone acetate or any excipient in the formulation. Methylprednisolone is contraindicated in patients with known hypersensitivity to methylprednisolone or any excipient in the formulation.

PBS listing

Information regarding PBS listing is not available in the provided source documents.

Regulatory history

YONSA MPRED abiraterone acetate 125 mg tablet bottle and methylprednisolone 4 mg tablet bottle composite pack was first listed on the ARTG on 2022-03-29. Yonsa Mpred, a composite pack of abiraterone acetate and methylprednisolone, was approved by the TGA for the treatment of metastatic prostate cancer. The decision was based on the demonstrated bioequivalence and comparable efficacy and safety profile of the lower-dose micronized formulation. The PBAC recommended YONSA MPRED in November 2022 for castration-resistant metastatic prostate cancer and in July 2023 for metastatic hormone sensitive prostate cancer.