IMPORTANT SAFETY INFORMATION—APRISO extended-release capsules

    • You should not take APRISO extended-release capsules if you experience an allergic reaction to salicylates or aminosalicylates, or to any of the components of APRISO capsules.
    • Kidney impairment has been reported in patients given products like APRISO (contain mesalamine or are converted to mesalamine). It is recommended that you have an evaluation of kidney function prior to treatment with APRISO therapy and periodically while on therapy. Talk to your doctor if you have any kidney problems before taking APRISO.

    Eligible Patients: You may pay no more than $0 on your first APRISO prescription, then no more than $10 on all future prescriptions for the duration of the program

    With APRISO, we not only may be able to help maintain remission of ulcerative colitis (UC), but we may also be able to help maintain your budget. Ulcerative colitis can be a challenging condition to keep under control, but money does not have to come between a patient with UC and maintaining remission.

    If you are an eligible commercially insured patient who has already received an APRISO Savings Card from your healthcare provider, all you have to do is activate it.

    Eligibility Criteria, Terms and Conditions:

    This offer is only valid for patients 18 years of age or older with commercial insurance, including commercially insured patients without coverage for APRISO. Patients without commercial insurance are not eligible. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. Eligible insured patients with coverage for APRISO pay a $0 co-pay for their initial prescription, and eligible insured patients without coverage for APRISO pay a $0 out-of-pocket expense. Salix Pharmaceuticals will pay the remaining co-pay/out-of-pocket expense up to the maximum amount of $110 for the first fill. For each subsequent use, the patient pays the initial $10, with a maximum benefit of $100. Maximum benefits apply. Maximum benefits are as follows: initial prescription/$110, for 1 use total for a calendar year, and for each subsequent prescription/$100, for 1 use per month for a calendar year. Offer expires 12/31/2017. Patient is responsible for all additional costs and expenses after the maximum limit is reached. You agree not to seek reimbursement for all or any part of the benefit received through this offer and are responsible for making any required reports of your use of this offer to any insurer, health plan, or other third party who pays any part of the prescription filled. This savings program cannot be combined with any other coupon, certificate, voucher, or similar offer. Offer good only in the USA at participating retail pharmacies and cannot be redeemed at government-subsidized clinics. Participation in this program must comply with all applicable laws and contractual or other obligations as a pharmacy provider. This card has no cash value and no other purchase is necessary. This card is not health insurance. Participating patients and pharmacists understand and agree to comply with the Terms and Conditions of this offer as set forth herein. Any step-edits or prior authorizations required by the insurance plan still apply. Salix Pharmaceuticals reserves the right to modify or cancel this program at any time. Savings card must be activated prior to use by visiting www.Aprisorx.comor by calling 855-740-3034. Participating patients must present their activated APRISO Instant Savings Card for every eligible prescription fill or refill.

    We need to know a little more about you before you can activate or download your card. Please fill out the information below.
    Please note, in order to download and print your card, you must have Adobe<sup>®</sup> Reader<sup>®</sup> installed on your computer. If you do not have this program, <a target="_newtab" onclick="urlclick('https://acrobat.adobe.com/us/en/products/pdf-reader.html');"><strong>click here</strong></a> to download.
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    All personal information will be kept confidential and will not be shared with any parties other than Salix Pharmaceuticals and its designated partners. <a href="http://www.valeant.com/privacy"><strong>View our full Privacy Policy</strong></a>.

    INDICATION

    APRISO® (mesalamine) extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older.

    IMPORTANT SAFETY INFORMATION—APRISO extended-release capsules

    • You should not take APRISO extended-release capsules if you experience an allergic reaction to salicylates or aminosalicylates, or to any of the components of APRISO capsules.

    • Kidney impairment has been reported in patients given products like APRISO (contain mesalamine or are converted to mesalamine). It is recommended that you have an evaluation of kidney function prior to treatment with APRISO therapy and periodically while on therapy. Talk to your doctor if you have any kidney problems before taking APRISO.

    • Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of your ulcerative colitis. Symptoms include cramping, acute abdominal (stomach) pain and bloody diarrhea, sometimes fever, headache, and rash. Talk to your doctor if you experience a worsening of these problems after you start treatment.

    • If you have liver disease, talk to your doctor before taking APRISO. There have been reports of liver failure in patients with liver disease who have taken mesalamine.

    • In the clinical studies, the most common side effects occurring in at least 3% of patients taking APRISO were headache, diarrhea, upper abdominal (stomach) pain, nausea, nasopharyngitis (inflammation of the nasal passages), flu and flu-like illness, and inflammation of the sinuses.

    • You should not take APRISO while taking antacids because the dissolving of APRISO granules depends on the acidity in your stomach.

    • If you are 65 years old or older, talk to your doctor before taking APRISO. Blood cell count must be monitored closely if you are 65 or older and on mesalamine therapy.

    • If you have phenylketonuria (PKU), please be aware that each APRISO capsule contains aspartame equivalent to 0.56 mg of phenylalanine, so that the recommended adult dosing provides an equivalent of 2.24 mg of phenylalanine per day.


    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.


    For product information, adverse event reports, and product complaint reports, please contact:
    Salix Product Information Call Center
    Phone: 1-800-508-0024
    Fax: 1-510-595-8183
    Email: salixmc@dlss.com

    Please click here for full Prescribing Information for APRISO extended-release capsules.