INDICATION

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

    Frequently asked questions about APRISO

    General APRISO information

    Medication savings offer

    What is APRISO and how does it work?

    APRISO is a prescription medicine that is used for the maintenance of remission of UC in patients 18 years of age and older.

    Back to top

    Who should not take APRISO?

    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.

    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.

    Back to top

    How often should I take APRISO?

    Four capsules, taken once a day, in the morning.

    Back to top

    Do I have to take APRISO on an empty stomach or with food?

    You can take APRISO with or without food. It passes through the stomach without being fully absorbed.

    Back to top

    Can I take other medications with APRISO?

    You should not take APRISO with antacids. It is always best to let your doctor know about any other medications you are currently taking, even if they are over-the-counter, nonprescription medications, or dietary supplements. Your doctor will tell you which other medications you may or may not take with APRISO.

    Back to top

    What safety concerns should I know about?

    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.

    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.

    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.

    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 of age 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.

    Please click here for the Important Safety Information for APRISO and here for the full Prescribing Information.

    Back to top

    Are there special offers for savings with APRISO?

    Yes. The APRISO Instant Savings Card is available for most eligible commercially insured patients.

    Back to top

    Can I print out an APRISO Instant Savings Card online?

    Yes. If you are an eligible patient and you did not receive an APRISO Instant Savings Card from your doctor, you can activate and download one by clicking here.

    Back to top

    If I fill my prescription through a mail-order pharmacy, how do I use my card?

    For mail-order purchases, please mail a copy of your card with your pharmacy receipt indicating your purchase of APRISO and the amount paid to: APRISO Instant Savings Card, 2250 Perimeter Park Dr., Suite 300, Morrisville, NC 27560.

    Back to top

    What do I do if my card doesn't work?

    If your card does not work for any reason, please mail a copy of your card with your pharmacy receipt indicating your purchase of APRISO and the amount paid to: APRISO Savings Card, 6501 Weston Pkwy, Suite 370, Cary, NC 27513. For immediate assistance, please contact the Pharmacy Helpdesk at 1-877-236-9519. The helpdesk is available 24 hours a day, Monday though Friday; Saturday from 8 AM to 7 PM EST; and Sunday from 8 AM to 5 PM EST.

    Back to top

    * 
    • 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.