MAKE THE MOVE TO INTELLICOR®

    INTELLICOR® delayed- and extended-release delivery initiates at pH ≥6, and is designed to provide locally acting coverage in the colon.1

    Delayed Release

    A once-daily morning dose of 4 APRISO 0.375-g capsules (1.5 g) releases hundreds of granules that dissolve at a pH ≥6, for a delayed release of mesalamine.1,2

    Extended Release

    As the outer coating of each APRISO granule dissolves, intestinal fluid activates a polymer matrix core, facilitating extended release of mesalamine.2,3

    APRISO

    Maintain Remission With a Once-daily Dose1

    • 1.5-g daily dose (4 APRISO 0.375-g capsules)
    • Can be taken with or without food
    • APRISO is pregnancy category B
    • APRISO is dibutyl phthalate (DBP)-free

    INDICATION

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

    IMPORTANT SAFETY INFORMATION—APRISO extended-release capsules

    • APRISO extended-release capsules are contraindicated in patients with hypersensitivity to salicylates or aminosalicylates, or to any of the components of APRISO capsules.
    • Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as APRISO that contain mesalamine or are converted to mesalamine. It is recommended that patients have an evaluation of renal function prior to initiation of APRISO therapy and periodically while on therapy. Exercise caution when using APRISO in patients with known renal dysfunction or a history of renal disease.
    • Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. If acute intolerance syndrome is suspected, promptly discontinue treatment with APRISO.
    • There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering APRISO to patients with liver disease.
    • In clinical studies, the most common adverse reactions (occurring in ≥3% of APRISO patients and at a greater rate than placebo) were headache (11%), diarrhea (8%), upper abdominal pain (5%), nausea (4%), nasopharyngitis (4%), influenza and influenza-like illness (4%), and sinusitis (3%).
    • Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be co-administered with antacids.
    • Because of the potential for blood dyscrasias in patients 65 years and older, caution should be taken to closely monitor blood cell counts during mesalamine therapy in these patients.
    • Inform patients with phenylketonuria (PKU) or their caregivers 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.

    To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-508-0024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

    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

    • References: 1. APRISO [prescribing information] Bridgewater, NJ: Salix Pharmaceuticals. 2. Oliveira L, Cohen R. Maintaining remission in ulcerative colitis—role of once daily extended-release mesalamine. Drug Des Devel Ther. 2011;5:111-116. 3. Zakko S, Gordon G, Murthy U. Once-daily mesalamine granules for maintaining remission of ulcerative colitis: pooled analysis of efficacy, safety, and prognostic factors. Postgraduate Medicine. 2016. DOI:10.1080/00325481.2016.1152876.