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    DEA Class; Rx

    Common Brand Names; Zytiga, Yonsa

    • Antineoplastics, Antiandrogen

    17 alpha-hydroxylase/C17,20-lyase (CYP17) inhibitor that blocks androgen biosynthesis
    Used in combination with a corticosteroid for the treatment of metastatic castration-resistant prostate cancer
    2 formulations (Zytiga and Yonsa) have different dosing recommendations and different food effects; do not substitute one for the other

    Indicated for the treatment of metastatic prostate cancer.

    Indicated in combination with prednisone for patients with metastatic castration-resistant prostate cancer (CRPC)

    Indicated in combination with methylprednisolone for the treatment of patients with metastatic CRPC


    Adverse drug reactions are for abiraterone with prednisone

    • Hypertriglyceridemia (63%)
    • Hyperglycemia, nonfasting (57%)
    • Increased ALT (11-46%)
    • Fatigue (39%)
    • Lymphopenia (20-38%)
    • Increased AST (15-37%)
    • Hypertension (8.5-37%)
    • Hypernatremia (33%)
    • Joint swelling/discomfort (30%)
    • Hypokalemia (17-30%)
    • Edema (25-27%)
    • Muscle discomfort (26%)
    • Hypophosphatemia (24%)
    • Constipation (23%)
    • Hot flush (15-22%)
    • Diarrhea (18-22%)
    • Hot flush (19%)
    • Cough (6.5-17%)
    • Increased total bilirubin (6.6-16%)
    • Insomnia (14%)
    • Contusion (13%)
    • Upper respiratory tract infection (5.4-13%)
    • Urinary tract infection (7-12%)
    • Dyspnea (12%)
    • Nasopharyngitis (11%)
    • Dyspepsia (6.1-11%)

    Caution in patients with a history of cardiovascular disease; safety in patients with LVEF <50% or NYHA Class III or IV heart failure is not established

    Hypertension, hypokalemia, and fluid retention may result from increased mineralocorticoid due to CYP17 inhibition; control hypertension and correct hypokalemia before treatment; monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly

    Closely monitor patients with medical conditions that might be compromised by increased blood pressure, hypokalemia, or fluid retention (eg, heart failure, recent MI, cardiovascular disease, ventricular arrhythmia)

    QT prolongation and Torsades de Pointes observed in patients who develop hypokalemia during postmarketing surveillance and additional clinical trials

    Adrenocortical insufficiency reported in patients receiving abiraterone in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress; monitor for symptoms and signs of adrenocortical insufficiency; increased corticosteroid dosage may be indicated before, during, and after stressful situations; concurrent infection or interruption of daily corticosteroids associated with adrenocortical insufficiency

    In postmarketing experience, severe hepatic toxicity, including fulminant hepatitis, acute liver failure and deaths occurred

    Drug plus prednisone/prednisolone not recommended for use in combination with radium 223 dichloride outside clinical trials; increased incidences of fractures (and deaths observed in patients who received drug plus prednisone/prednisolone in combination with radium Ra 223 dichloride compared to placebo in combination with drug plus prednisone/prednisolone

    Based on animal studies and mechanism of action, may cause fetal harm and loss of pregnancy

    Based on findings from animal studies and mechanism of action, abiraterone is contraindicated for use in pregnant women because drug can cause fetal harm and potential loss of pregnancy

    Not indicated for use in females

    Not indicated for women

    No information available on the presence of abiraterone acetate in human milk, or on the effects on the breastfed child or milk production


    Zytiga: 1,000 mg PO once daily.
    Yonsa: 500 mg PO once daily.


    Zytiga: 1,000 mg PO once daily.
    Yonsa: 500 mg PO once daily.


    Safety and efficacy have not been established.


    Safety and efficacy have not been established.


    Not indicated.


    Not indicated.

    Abiraterone acetate

    tablet (Zytiga)

    • 250mg
    • 500mg

    ultramicronized tablet (Yonsa)

    • 125mg