These highlights do not include all the information needed to use ZYTIGA safely and effectively. See full prescribing information for ZYTIGA.
ZYTIGA® (abiraterone acetate) tablets, for oral use
Initial U.S. Approval: 2011
RECENT MAJOR CHANGES
Warnings and Precautions (5.1) 06/2019
Warnings and Precautions (5.4) 06/2019
Warnings and Precautions (5.5) 06/2019
INDICATIONS AND USAGE
ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with
metastatic castration-resistant prostate cancer (CRPC). (1)
metastatic high-risk castration-sensitive prostate cancer (CSPC). (1)
DOSAGE AND ADMINISTRATION
Metastatic castration-resistant prostate cancer:
ZYTIGA 1,000 mg orally once daily with prednisone 5 mg orally twice daily. (2.1)
Metastatic castration-sensitive prostate cancer:
ZYTIGA 1,000 mg orally once daily with prednisone 5 mg orally once daily. (2.2)
Patients receiving ZYTIGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ZYTIGA must be taken on an empty stomach with water at least 1 hour before or 2 hours after a meal. Do not crush or chew tablets. (2.3)
Dose Modification:
For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the ZYTIGA starting dose to 250 mg once daily. (2.4)
For patients who develop hepatotoxicity during treatment, hold ZYTIGA until recovery. Retreatment may be initiated at a reduced dose. ZYTIGA should be discontinued if patients develop severe hepatotoxicity. (2.4)
DOSAGE FORMS AND STRENGTHS
Film-Coated Tablet 500 mg (3)
Uncoated Tablet 250 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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. (5.1)
Adrenocortical insufficiency: Monitor for symptoms and signs of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations. (5.2)
Hepatotoxicity: Can be severe and fatal. Monitor liver function and modify, interrupt, or discontinue ZYTIGA dosing as recommended. (5.3)
Increased fractures and mortality in combination with radium Ra 223 dichloride: Use of ZYTIGA plus prednisone/prednisolone in combination with radium Ra 223 dichloride is not recommended. (5.4)
Embryo-Fetal Toxicity: ZYTIGA can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception. (5.5, 8.1, 8.3)
ADVERSE REACTIONS
The most common adverse reactions (≥10%) are fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache. (6.1)
The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, and hypokalemia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during ZYTIGA treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA dosing frequency. (2.5, 7.1)
CYP2D6 Substrates: Avoid co-administration of ZYTIGA with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate. (7.2)
USE IN SPECIFIC POPULATIONS
Do not use ZYTIGA in patients with baseline severe hepatic impairment (Child-Pugh Class C). (8.6)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 6/2019
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