COVID-19: Letter from Sun Pharmaceutical Industries

YONSA® is the first and only micronized abiraterone acetate formulation approved by the FDA, 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

Proprietary YONSA®
micronization provides:

  • No food restrictions1

    YONSA® gives patients the flexibility to take it with or without food2
  • Increased absorption

    Because a greater part of the active drug is getting absorbed, YONSA® is given as a 500 mg dose (four 125 mg tablets) taken once daily in combination with 4 mg methylprednisolone twice daily1,3
  • Similar bioavailability1

    YONSA®, in combination with 4 mg methylprednisolone, provides similar bioavailability to 1000 mg of abirateroneacetate with corticosteroid at a 500 mg dose.
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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 two 4 mg methylprednisolone)1
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


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 corticosteroid

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 chemotherapy:

 

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 (0-1 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.

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.

Please see additional Important Safety Information throughout.


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.

$5,000 maximum program benefit per fill and $12,000 maximum program benefit per calendar year. Not valid for patients without commercial insurance coverage or if prescription is paid for by any state or federally funded healthcare program, including but not limited to Medicare, Medicaid, VA, DOD, or TRICARE. Available to US, Guam, Virgin Islands, or Puerto Rico residents only. See Full Terms and Conditions below.

Income documentation is required.


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

 

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PRIOR AUTHORIZATION
ASSISTANCE

POWERED BY COVERMYMEDS®

Sun Pharma and CoverMyMeds are working together to expedite the prior authorization process to help your patients receive their YONSA® therapy as prescribed.

For more information, contact CoverMyMeds at 1-866-452-5017.

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TERMS AND CONDITIONS
Eligible commercially insured patients 18 years or older pay as little as $10/month for a YONSA® prescription. Patients must have a valid prescription and commercial, prescription drug insurance coverage. To enroll in the YONSA® Co-Pay Program (this “Program”), present the Program card along with a valid prescription to the pharmacist at any participating pharmacy.

Terms and Conditions: By enrolling in the Program, you are certifying that you understand these terms and conditions and that you have/will respond truthfully to the questions presented to you for enrollment. Eligibility: The Program is limited to patients residing in the United States, Puerto Rico, Guam, and the Virgin Islands, excluding patients residing in Massachusetts (effective January 1, 2021). If the FDA approves a therapeutically equivalent Rx drug or if an OTC drug containing abiraterone acetate (the active ingredient in YONSA®) becomes available, the Program will exclude patients residing in California. The program is not open to patients with no insurance coverage, who have coverage that imposes no co-pay or co-insurance charge (i.e. insurance covering the full cost of YONSA®), or who are covered by a government program including: Medicare, Medicaid, TRICARE, the Veterans Affairs, the Department of Defense, or have prescription drug coverage under any other federal or state program. In addition, if a patient obtains coverage from such a government program after enrolling in this program, he/she will not be eligible to continue in the Co-Pay Program. Maximum Benefit: The maximum benefit allowed under the Program is $12,000 in each calendar year and no more than $5,000 for each individual prescription filled. Additional Requirements: This offer is not transferrable and cannot be combined with any other offer, free trial, prescription savings card, or discount. Participation in the Program is not conditioned on any past, present, or future purchase. Patients may not apply for reimbursement and for all or any part of any benefit they receive from their health insurance or any third party and must report to their insurer or health plan administrator, if required, that they have enrolled in this program and are/will receive a financial benefit. The Program card is accepted only at participating pharmacies. There may be additional terms and conditions that also apply. Legal Notice: This Program is not health insurance. This Program is void where prohibited or restricted by law. Any sale, purchase, trade, counterfeiting, duplication, or reproduction of this card or offer to do so, is prohibited by law. Term: This offer expires on 3/31/2021 but may be canceled or changed, without notice, at any time. Use of Personal Data: Data related to your redemption of the card may be collected, combined with data from other co-pay card redemptions, de-identified, and shared with the Program sponsor (Sun Pharmaceutical Industries, Inc.), market research, program assessment, and for other lawful purposes.

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