These highlights do not include all the information needed to use YONSA safely and effectively. See full prescribing information for YONSA.
YONSA� (abiraterone acetate) tablets, for oral use
Initial U.S. Approval: 201
INDICATIONS AND USAGE
YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). (1) (1)
DOSAGE AND ADMINISTRATION
To avoid medication errors and overdose, be aware that YONSA tablets may have different dosing and food effects than other abiraterone acetate products. (2)
Recommended dose: YONSA 500 mg (four 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily. (2)
Patients receiving YONSA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (2.2) (2)
YONSA tablets can be taken with or without food. The tablets should be swallowed whole with water. Do not crush or chew tablets. (2.1) (2)
Dose Modification: (2)
For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the YONSA starting dose to 125 mg once daily. (2.2)
For patients who develop hepatotoxicity during treatment, hold YONSA until recovery. Retreatment may be initiated at a reduced dose. YONSA should be discontinued if patients develop severe hepatotoxicity. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 125 mg (3)
Pregnancy. (4.1, 8.1)
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 YONSA dosing as recommended. (5.3)
The most common adverse reactions (? 10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.
The most common laboratory abnormalities (> 20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during YONSA treatment. If a strong CYP3A4 inducer must be co-administered, increase the YONSA dosing frequency ( 2.4, 7.1)
CYP2D6 Substrates: Avoid co-administration of YONSA 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
Females and Males of Reproductive Potential: Advise males with female partners of reproductive potential to use effective contraception. ( 8.3)
Do not use YONSA in patients with baseline severe hepatic impairment (Child-Pugh Class C). (8.6)
See 17 for PATIENT COUNSELING INFORMATION.