Abiraterone

Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with

• Metastatic castration-resistant prostate cancer (CRPC)

• Metastatic high-risk castration-sensitive prostate cancer (CSPC)

Metastatic castration-resistant prostate cancer:

• Abiraterone acetate tablets  1,000 mg orally once daily with prednisone 5 mg orally

Metastatic castration-sensitive prostate cancer:

• Abiraterone acetate tablets 1,000 mg orally once daily with prednisone 5 mg orally

Patients receiving abiraterone acetate tablets should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Abiraterone acetate tablets must be taken as a single dose once daily on an empty stomach. Do not eat food 2 hours before and 1 hour after taking abiraterone acetate tablets. The tablets must be swallowed whole with water. Do not crush or chew tablets.

Dose Modification:

• For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the abiraterone acetate tablets  starting dose to 250 mg once daily.

• For patients who develop hepatotoxicity during treatment, hold abiraterone acetate tablets  until recovery. Retreatment may be initiated at a reduced dose. Abiraterone acetate tablets  should be discontinued if patients develop severe hepatotoxicity.

 Film-Coated Tablets (250 mg): beige colored, oval shaped, film-coated tablets debossed with “MA” on one side and “21” on other side.

 Film-Coated Tablets (500 mg): purple colored, oval shaped, film-coated tablets debossed with “MA” on one side and “22” on other side.

 Uncoated Tablets (250 mg): white to off-white, oval-shaped tablets debossed with “ABR” on one side and “250” on other side.

     

• Do not use abiraterone acetate in patients with baseline severe hepatic impairment (Child-Pugh Class C).

• Mineralocorticoid excess: Closely monitor patients with cardiovascular disease. Control hypertension and correct hypokalemia before treatment. Monitor blood pressure, serum potassium and symptoms of fluid retention at least monthly.

• Adrenocortical insufficiency: Monitor for symptoms and signs of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations.

• Hepatotoxicity: Can be severe and fatal. Monitor liver function and modify, interrupt, or discontinue abiraterone acetate dosing as recommended.

• Embryo-Fetal Toxicity: Abiraterone acetate can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.

• Hypoglycemia: Severe hypoglycemia has been reported in patients with pre-existing diabetes who are taking medications containing thiazolidinediones (including pioglitazone) or repaglinide. Monitor blood glucose in patients with diabetes and assess if antidiabetic agent dose modifications are required.