YONSA 125 mg/1

abiraterone acetate · TABLET · Sun Pharmaceutical Industries, Inc.

No Recall History

Plain English

YONSA is a tablet containing abiraterone acetate at 125 mg/1, taken oral. Manufactured by Sun Pharmaceutical Industries, Inc..

Key Facts

Brand Name: YONSA
Generic Name: abiraterone acetate
NDC Code (Product): 47335-401
Manufacturer: Sun Pharmaceutical Industries, Inc.
Strength: 125 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA210308
Marketing Start: 05/22/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death679 reports

fatigue474 reports

hot flush276 reports

asthenia262 reports

anaemia234 reports

hypokalaemia231 reports

drug ineffective212 reports

prostatic specific antigen increased211 reports

diarrhoea209 reports

hypertension202 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 )

Dosage & Administration

2 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. Recommended dose: YONSA 500 mg (four 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily. ( 2.1 ) Patients receiving YONSA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ( 2.2 ) YONSA tablets must be taken as a single dose once daily with or without food. The tablets should be swallowed whole with water. Do not crush or chew tablets. ( 2.1 ) Dose Modification: For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the YONSA starting dose to 125 mg once daily. ( 2.3 ) 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 ) 2.1 Recommended Dosage The recommended dose of YONSA is 500 mg (four 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg…

Contraindications

4 CONTRAINDICATIONS None. None

Drug Interactions

7 DRUG INTERACTIONS 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 ) 7.1 Effect of Other Drugs on YONSA Strong CYP3A4 Inducers The co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during YONSA treatment. If a strong CYP3A4 inducer must be co-administered with YONSA, increase the YONSA dosing frequency [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 )]. 7.2 Effect of YONSA on Other Drugs CYP2D6 Substrates Abiraterone is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6. The co-administration of YONSA with CYP2D6 substrates increases the concentration of the CYP2D6 substrate, which may increase the frequency and/or severity of adverse reactions of these substrates. Avoid co-administrat…

Adverse Reactions

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess [see Warnings and Precautions ( 5.1 )] . Adrenocortical Insufficiency [see Warnings and Precautions ( 5.2 )] . Hepatotoxicity [see Warnings and Precautions ( 5.3 )] . Increased Fractures and Mortality in Combination with Radium Ra 223 Dichloride [see Warnings and Precautions ( 5.4 )] . 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. ( 6.1 ) The most common laboratory abnormalities (> 20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia. ( 6.1 ) 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 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed…

Frequently Asked Questions

What is YONSA used for?

YONSA contains abiraterone acetate. It is a tablet taken oral. Consult your doctor for specific uses.

Is YONSA a controlled substance?

YONSA is not classified as a controlled substance by the DEA.

What is the generic name for YONSA?

The generic name for YONSA is abiraterone acetate. There are 11 other brand versions of abiraterone acetate.

What is the NDC code for YONSA 125 mg/1?

The NDC (National Drug Code) for YONSA 125 mg/1 is 47335-401, listed by Sun Pharmaceutical Industries, Inc..

Product NDC

47335-401

Package NDC

47335-401-81

Other Abiraterone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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