Warning and precautions for acetic acid abiolone

(1) Excessive corticosteroids: Patients with a history of cardiovascular disease should use ZYTIGA with caution. The safety of ZYTIGA has not been determined in patients with LVEF<50% or NYHA Class III or IV heart failure with ejection fraction. Control hypertension and correct hypokalemia before treatment. Monitor blood pressure, serum potassium and fluid retention symptoms at least once a month.
(2) Adrenal cortical insufficiency: Monitor the symptoms and signs of adrenal cortical insufficiency. Before, during, and after an emergency situation, it may be appropriate to increase the dose of corticosteroids.
(3) Hepatotoxicity: An increase in liver enzymes has led to drug interruption, dosage adjustment, and/or termination. Monitor liver function and adjust as recommended, interrupt or terminate ZYTIGA administration.
(4) Food impact: ZYTIGA must be taken on an empty stomach. The exposure (area under the curve) to abiraterone acetate increased by up to 10 times when taken simultaneously with food.