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COVID-19: Letter from Sun Pharmaceutical Industries
SAFETY PROFILE
The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection, and contusion.
Proprietary YONSA®
micronization provides:
No food restrictions1,3
YONSA® gives patients the flexibility to take it with or without foodIncreased absorption1,2
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 dailySimilar bioavailability2
YONSA®, in combination with 4 mg methylprednisolone, provides similar bioavailability to 1000 mg of abiraterone acetate with corticosteroid at a 500 mg dose.
TRICARE Network
Providers:
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our exclusive
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the Department
of Defense.
WARNINGS AND PRECAUTIONS
Hypertension, Hypokalemia, and Fluid Retention Due to Mineralocorticoid Excess: YONSA® may cause hypertension, hypokalemia, and fluid retention due to increased mineralocorticoid levels resulting from CYP17 inhibition. Monitor patients at least once a month. Control hypertension and correct hypokalemia before and during treatment with YONSA®.
benefits of
micronization
pharmacy can order
YONSA® today
YONSA® is the first and only micronized formulation of abiraterone acetate1
Micronization increases the particle’s surface area and enables more rapid dissolution and absorption; this results in2:
- A 500 mg dose (four 125 mg tablets plus two 4 mg methylprednisolone)1
YONSA® is the only abiraterone acetate with no food restrictions1,4
YONSA® gives patients dosing administration flexibility1
- YONSA®, taken in combination with methylprednisolone, is the only abiraterone acetate with no food restrictions, giving patients the flexibility to take it with or without food1,3
- The formulation was designed to improve oral bioavailability and reduce food effects3
Only YONSA® is FDA-approved to treat mCRPC at a 500 mg dose1
- YONSA® 500 mg (four 125 mg tablets) is administered orally once daily in combination with oral methylprednisolone (4 mg per dose twice daily)
Dose modification1
- For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the YONSA® starting dose to 125 mg once daily
- 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
SAFETY PROFILE
The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection, and contusion.
In a randomized, placebo-controlled, multicenter phase 3 clinical trial, patients with mCRPC who had received prior docetaxel chemotherapy received abiraterone acetate at a dose equivalent to YONSA® 500 mg once daily in combination with methylprednisolone twice daily (N=797), or placebo (N=398).4
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 corticosteroid1,4
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:
- A total of 1195 patients were randomized 2:1 to receive either abiraterone acetate orally at a dose equivalent to 500 mg of YONSA® once daily in combination with a different corticosteroid orally twice daily (N=797) or placebo once daily plus a different corticosteroid orally twice daily (N=398). Patients randomized to either arm were to continue treatment until disease progression (defined as a 25% increase in prostate-specific antigen [PSA] over the patient’s baseline/nadir together with protocol-defined radiographic progression and symptomatic or clinical progression), initiation of new treatment, unacceptable toxicity, or withdrawal1
- Significant improvement in overall survival was seen among patients receiving abiraterone acetate at a dose equivalent to YONSA® 500 mg once daily in combination with methylprednisolone twice daily vs placebo1
| 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) | |
†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:
- 1088 patients were randomized 1:1 to receive either abiraterone acetate at a dose equivalent to 500 mg of YONSA® once daily (N=546) or placebo once daily (N=542). Both arms were also given a different corticosteroid twice daily. Patients continued treatment until radiographic or clinical (cytotoxic chemotherapy, radiation, or surgical treatment for cancer; pain requiring chronic opioids; or Eastern Cooperative Oncology Group [ECOG] performance status decline to 3 or more) disease progression, unacceptable toxicity, or withdrawal. Patients with moderate or severe pain, opiate use for cancer pain, or visceral organ metastases were excluded1
| 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) | |
†Hazard ratio is derived from a stratified proportional hazards model. Hazard ratio ‹ 1 favors abiraterone acetate.
YONSA SUPPORT® programs provide a simple path to services
YONSA SUPPORT® is a comprehensive resource for patients taking YONSA®
Co-Pay Program*
- Patients can check eligibility and activate the co-pay card by visiting www.activatethecard.com/7702
- Eligible, commercially insured patients may pay as little as $0 for each fill of a YONSA® prescription, subject to a maximum program benefit per fill
- Maximum benefit of up to $6,000 per calendar year*
Patient Assistance Program (PAP)†
- Patients who are underinsured or uninsured may be eligible to receive free medication. To get your patients started with the Patient Assistance Program, simply complete the YONSA SUPPORT® Patient Assistance Program Application, which is available below
*Subject to Terms and Conditions below.
†Income documentation is required.
YONSA SUPPORT® is a comprehensive resource for patients taking YONSA®
- If you have questions, please contact YONSA SUPPORT® at 1-855-984-6307
patients in the
Co-Pay Program
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.
Other materials for download
CO-PAY TERMS AND CONDITIONS
To participate in the YONSA® Co-Pay Program (“Program”), you must present this card, along with a valid prescription for YONSA®, to your pharmacist. Patients with commercial health insurance who qualify to participate can pay as little as $0 per month for one YONSA® prescription. Enrollment is subject to the Eligibility Rules and Terms and Conditions, stated below. If you have any questions regarding Eligibility, the Terms and Conditions, or to discontinue participation, please call 1-855-984-6307 (8:00 am-8:00 pm EST, Monday-Friday).
Eligibility Rules
- To participate in this Program, you must have commercial health insurance and be a resident of the United States (excluding patients residing in Massachusetts), Puerto Rico, Guam, or the Virgin Islands
- Patients who are members of health plans (often termed "maximizer" plans) that claim to reduce their patients' out-of-pocket costs may have a reduced maximum program benefit of $6,000 per calendar year. Out-of-pocket costs may be co-pay, co-insurance, or deductible
- The following patients are ineligible for this Program:
- Patients covered under Medicaid (including Medicaid patients enrolled in a Medicaid Managed Care Plan or a qualified health plan purchased through a health insurance exchange marketplace established by a state government or the federal government)
- Patients covered by Medicare or a Medicare Part D or Medicare Advantage plan (regardless of whether a specific prescription is covered)
- Patients covered by TRICARE, CHAMPUS, Puerto Rico Government Health Insurance Plan or any other state or federal medical or pharmaceutical benefit program or pharmaceutical assistance program
- Patients who are members of health plans that claim to eliminate their out-of-pocket costs are not eligible for cost support. If you are a member of one of these plans, please call 1-877-264-2440
- Patients with no insurance
Terms and Conditions
- You agree to not to seek any reimbursement for all or any part of the co-pay assistance received through the Program. By using this card, you are certifying that you understand the Eligibility Rules and Terms and Conditions, that you have responded truthfully to questions when activating the card, and that you will disclose and report your receipt of any Program benefits to your insurer, health plan, or any third party that pays or reimburses you for the cost of medications, if required
- This offer may be rescinded, revoked, or cancelled at any time, without further notice, and the rules may be amended at any time, without further notice
Disclosures
- This Program is not insurance
- The Program is void where prohibited by law, taxed, or restricted. Any benefit provided is non-transferable, and cannot be combined with any other program, free trial, discount, prescription savings card, or other offer. No purchase, other than for a YONSA® prescription, is required to participate
- Personal data that you provide to the Program may be collected, analyzed, and shared with the Program sponsor for market research and other lawful purposes, but only in aggregated and de-identified form