The First and Only Micronized Abiraterone Acetate Formulation Approved by the FDA for the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC),1 When Used in Combination With Methylprednisolone

The advanced technology used in the formulation of YONSA® reduces abiraterone acetate particle size down to 200 to 800 nanometers in diameter2

  • No food restrictions1

    YONSA® gives patients the flexibility to take it with or without food1
  • Increased absorption

    Because a greater part of the active drug is getting absorbed, YONSA® is given as a 500 mg dose taken once daily in combination with 4 mg methylprednisolone twice daily1,2
  • Similar bioavailability1,2

    YONSA®, in combination with 4 mg methylprednisolone, provides similar bioavailability to 1000 mg of abiraterone acetate with corticosteroid at a 500 mg dose (four 125 mg tablets plus 4 mg methylprednisolone administered twice daily)

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YONSA® is the First and Only Micronized Formulation of Abiraterone Acetate

Watch the video to learn how micronization affects the absorption of abiraterone acetate.

Micronization increases the particle’s surface area and enables more rapid dissolution and absorption; this results in3:

  • A 500 mg dose (four 125 mg tablets plus 4 mg methylprednisolone administered twice daily)
  • No food restrictions3
  • Consistent blood levels3
power-of-micronization
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YONSA® is the Only Abiraterone Acetate With No Food Restrictions1

YONSA® gives patients dosing administration flexibility

Only YONSA® is FDA-approved to treat mCRPC at a 500 mg dose1,4


Tablets not to scale.

Dose modification

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YONSA® 500 mg, in Combination With 4 mg Methylprednisolone, Provides Similar Bioavailability to the 1000 mg Dose of Another Abiraterone Acetate Taken in Combination With a Corticosteroid1,2

YONSA® may not be interchangeable with other abiraterone acetate products. To avoid substitution errors and overdose, be aware that YONSA® tablets may have different dosing and food effects than other abiraterone acetate products.1

In patients with mCRPC who received prior docetaxel chemotherapy1:

Overall Survival of Patients Treated With Either Abiraterone Acetate or Placebo in Combination With Corticosteroid in Study 1 (Intent-to-Treat Analysis)1
Primary Survival Analysis Abiraterone Acetate With Corticosteroid (N=797) Placebo With Corticosteroid (N=398)
Deaths (%) 333 (42%) 219 (55%)
Median survival (months; 95% CI) 14.8 (14.1, 15.4) 10.9 (10.2, 12.0)
P value* <0.0001
Hazard ratio (95% CI) 0.646 (0.543, 0.768)
Updated Survival Analysis
Deaths (%) 501 (63%) 274 (69%)
Median survival (months; 95% CI) 15.8 (14.8, 17.0) 11.2 (10.4, 13.1)
Hazard ratio (95% CI) 0.740 (0.638, 0.859)
*P value is derived from a log-rank test stratified by ECOG performance status score (0 vs 1).

Hazard ratio is derived from a stratified proportional hazards model. Hazard ratio ‹1 favors abiraterone acetate.

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS

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.


In patients with mCRPC who did not receive prior cytotoxic chemotherapy:

Overall Survival of Patients Treated With Either Abiraterone Acetate or Placebo in Combination With Corticosteroid in Study 2 (Intent-to-Treat Analysis)1
Primary Survival Analysis Abiraterone Acetate With Corticosteroid (N=546) Placebo With Corticosteroid (N=542)
Deaths (%) 354 (65%) 387 (71%)
Median survival (months; 95% CI) 34.7 (3.7, 36.8) 30.3 (28.7, 33.3)
P value* 0.0033
Hazard ratio (95% CI) 0.81 (0.70, 0.93)
*P value is derived from a log-rank test stratified by ECOG performance status score (0-1 vs 2), pain score (absent vs present), number of prior chemotherapy regimens (1 vs 2), and type of disease progression (PSA only vs radiographic).

Hazard ratio is derived from a stratified proportional hazards model. Hazard ratio ‹1 favors abiraterone acetate.

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YONSA SUPPORT™ Programs Provide a Simple Path to Services*

YONSA SUPPORT™ is a comprehensive resource for patients taking YONSA®

*Subject to terms and conditions. Must be enrolled in YONSA SUPPORT™ to qualify.

Co-pay Program Terms and Conditions: Eligible commercially insured patients may pay as little as $10/fill on a YONSA® prescription, subject to maximum program benefits of $5,000 per fill, up to $12,000 per calendar year. After the program maximum, you will be responsible for the difference. This offer is valid only for those with commercial insurance and who have a valid prescription. This offer is not valid under Medicare, Medicaid, or any other federal or state program, for cash-paying patients, or where a plan reimburses you for the entire cost of your prescription drug. This offer is not transferrable, and cannot be combined with any other offer. This offer is not health insurance and is only valid for patients in the United States, Puerto Rico, Guam, and Virgin Islands. If you live in Massachusetts, card expires on the earlier of 2018, or date AB-rated generic equivalent is available. Void where prohibited or restricted. Additional terms and conditions may apply. This offer may change at any time, without notice. When you use this card, you are certifying that you understand the program rules, regulations, and these Terms and Conditions; that you have responded truthfully to questions when activating the card; and that you will disclose and report the use of this offer as may be required by your insurer. It is illegal to, or offer to, sell, purchase, trade, counterfeit, duplicate, or reproduce the card. This card must be presented to the pharmacist with a valid prescription to participate in this program. If you have any questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call YONSA SUPPORT™ at 1-855-984-6307 (8:00 AM-8:00 PM EST, Monday-Friday). Sun Pharmaceutical reserves the right to modify or discontinue this offer at any time without notice.


YONSA SUPPORT™ is a comprehensive resource for patients taking YONSA®

 
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IMPORTANT SAFETY INFORMATION Expand

INDICATION
YONSA® (abiraterone acetate) in combination with methylprednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

Important Administration Instructions
YONSA® may not be interchangeable with other abiraterone acetate products. To avoid substitution errors and overdose, be aware that YONSA® tablets may have different dosing and food effects than other abiraterone acetate products. Patients receiving YONSA® should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

YONSA® can cause fetal harm and potential loss of pregnancy.

WARNINGS AND PRECAUTIONS

Hypertension, Hypokalemia, and Fluid Retention Due to Mineralocorticoid Excess: YONSA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with YONSA®.

Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. The safety of YONSA® in patients with left ventricular ejection fraction ‹ 50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials.

Adrenocortical Insufficiency (AI): AI was reported in patients receiving abiraterone acetate in combination with corticosteroid, following an interruption of daily steroids and/or with concurrent infection or stress. Monitor patients for symptoms and signs of AI, particularly if patients are withdrawn from corticosteroids, have corticosteroid dose reductions, or experience unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with YONSA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity: In postmarketing experience, there have been abiraterone acetate-associated severe hepatic toxicity, including fulminant hepatitis, acute liver failure and deaths. Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with YONSA®, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced YONSA® dose of 125 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt YONSA® treatment and closely monitor liver function.

Re-treatment with YONSA® at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN.

Permanently discontinue treatment with abiraterone acetate for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation.

The safety of YONSA® re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

Based on in vitro data, YONSA® is a substrate of CYP3A4. In a drug interaction trial, 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, increase the YONSA® dosing frequency only during the coadministration period.

Abiraterone is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. Avoid coadministration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug.

In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone (CYP2C8 substrate) was increased by 46% when pioglitazone was given together with an abiraterone acetate single dose equivalent to YONSA® 500 mg. Therefore, patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with abiraterone acetate.

USE IN SPECIFIC POPULATIONS
  • Females and Males of Reproductive Potential: Advise male patients with female partners of reproductive potential to use effective contraception.
  • Do not use YONSA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Please see Full Prescribing Information for YONSA® at www.YonsaRx.com/Yonsa-pi

References: 1. YONSA® (abiraterone acetate) tablets [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc; May 2018. 2. Goldwater R, Hussaini A, Bosch B, Nemeth P. Comparison of a novel formulation of abiraterone acetate vs. the originator formulation in healthy male subjects: two randomized, open-label, crossover studies. Clin Pharmacokinet. 2017;56:803–813. 3. Hussaini A, Olszanski AJ, Stein CA, Bosch B, Nemeth P. Impact of an alternative steroid on the relative bioavailability and bioequivalence of a novel versus the originator formulation of abiraterone acetate. Cancer Chemo Pharmacol. 2017;80(3):479-486. 4. ZYTIGA® (abiraterone acetate) tablets [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; 2018.