Make maintaining remission your mission with APRISO

    How once-daily APRISO may help you stay in ulcerative colitis (UC) remission

    APRISO is a type of medication called mesalamine, or 5-ASA, and is thought to work by reducing inflammation and irritation in the colon. APRISO capsules are made with a special INTELLICOR® technology, designed to reach the colon and work right at the source of UC symptoms and "flare-ups."

    What APRISO offers:

    • Maintenance of UC remission: In clinical studies, approximately 7 of 10 adult patients maintained UC remission (were relapse free) for up to 6 months with APRISO, compared with approximately 5.5 of 10 adult patients taking placebo (or sugar pill). In these studies, stopping the drug for any reason was counted as relapse
    • INTELLICOR® technology: Mesalamine is released slowly over time, so it can reach the inside of your colon and work right at the source of UC symptoms
    • Low side effects: In clinical studies, the most common side effects occurring in 3% or more of adult 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
    • Once-a-day treatment: Four APRISO capsules should be taken once in the morning, with or without food
    • Savings on each prescription: With the APRISO Instant Savings Card, if you are an eligible commercially insured patient, you can pay $0 on your first prescription, and $10 on future prescriptions*
    * 
    • This APRISO Instant Savings Card 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, or the Puerto Rico Government Health Insurance Plan. 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. Salix Pharmaceuticals reserves the right to rescind, revoke, or amend this offer at any time without notice.

    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.