PROVEN EFFICACY OF APRISO

    In Studies 1 and 2, the proportion of patients who remained relapse free* at 6 months was greater for APRISO than for placebo.1

    A chart shows that APRISO 1.5g/day helped patients stay relapse free for up to 6 months. A chart shows that APRISO 1.5g/day helped patients stay relapse free for up to 6 months. A chart shows which products patients were taking prior to initiating APRISO in clinical trials.
     
    • ~7 of 10 patients (withdrawals for any reason were counted as relapse) maintained UC remission for up to 6 months with APRISO, compared with ~5.5 of 10 adult patients taking placebo1
    • In studies 1 and 2, 87% of patients were previously taking a 5-ASA, and 5-ASA use was discontinued prior to the first dose of APRISO or placebo2

    Study Design: In 2 randomized, double-blind, placebo-controlled, multicenter trials conducted in 562 adult patients in remission from UC, the effectiveness and safety of APRISO 1.5 g given once daily compared with placebo was evaluated. Subjects were randomized in a 2:1 ratio to receive either 1.5 g (4 capsules total) or matching placebo capsules for 6 months. The primary endpoint was the proportion of patients who remained relapse free at 6 months (the end of the trial). Relapse was defined as a rectal bleeding subscale score of ≥1 and a mucosal appearance score of ≥2 on the Sutherland Disease Activity Index (UCDAI). All early study withdrawals were considered treatment failures.1

    Study Design: A post hoc analysis of 2 identically designed, prospective, randomized, double-blind, placebo-controlled, 6-month, multicenter trials was conducted in 487 adult patients with UC to evaluate the efficacy of once-daily granulated mesalamine 1.5 g vs placebo, in the maintenance of remission from UC, in patients who switched from other 5-ASA formulations. Patients were randomized 2:1 for granulated mesalamine and placebo, respectively.2

    *Relapse counted as a UCDAI rectal bleeding score of ≥1 and mucosal appearance score of ≥2, or premature withdrawal for any reason.
    †Some subjects used multiple formulations; therefore, the total number of treatments (522) is greater than the number of participants (487).

     

    LONG-TERM SAFETY PROFILE

    The safety of APRISO has been evaluated in two 6-month placebo-controlled trials and for up to 24 months in an open-label extension study1,3

    The safety and efficacy of APRISO for treating ulcerative colitis beyond 6 months has not been evaluated in controlled clinical trials.

     

    In clinical trials, APRISO was generally well tolerated, with most AEs reported as mild to moderate in severity1

    A chart shows the most common treatment-related Adverse Events experienced by greater or equal to 3% of APRISO-treated patients and at a greater rate than with APRISO.
     

    The long-term tolerability of APRISO was evaluated up to 24 months in an open-label extension study3


    A chart shows the most common treatment-related Adverse Events were experienced by greater or equal to 5% of APRISO-treated patients and at a higher rate than historical placebo group.

    Study Design: A phase 3, multicenter, 24-month, open-label extension study evaluated the safety and tolerability of once-daily APRISO (1.5 g) in 388 patients who previously achieved remission from mild to moderate UC. Eligible, enrolled patients had successfully participated in 1 of 2 previous phase 3, 6-month, double-blind, placebo-controlled trials (n=280), or were new patients in remission (n=113). Safety was assessed during clinic visits by monitoring AEs and the performance of clinic laboratory tests. A post hoc analysis of UC-related AEs was used to determine the risk of UC recurrence.3

    INDICATION

    APRISO® (mesalamine) extended-release capsules are indicated for the maintenance of remission of ulcerative colitis (UC) in adults

    IMPORTANT SAFETY INFORMATION

    • 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.
    • Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. Consider an alternative, selective assay for normetanephrine.
    • Discontinue APRISO at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
    • Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad spectrum sun screen outdoors.
    • Cases of nephrolithiasis have been reported with the use of mesalamine, Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment with APRISO.
    • 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. OR Please see 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

    • References:
    • 1. APRISO [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals.
    • 2. Lichtenstein GR, Zakko S, Gordon GL, et al. Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations: a pooled analysis from two randomised controlled trials. Aliment Pharmacol Ther. 2012;36(2):126-134.
    • 3. Lichtenstein GR, Barrett AC, Bortey E, et al. Long-term safety and tolerability of once-daily mesalamine granules in the maintenance of remission of ulcerative colitis. Inflamm Bowel Dis. 2014;20(8):1399-1406.
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    INDICATION

    APRISO® (mesalamine) extended-release capsules are indicated for the maintenance of remission of ulcerative colitis (UC) in adults

    IMPORTANT SAFETY INFORMATION

    • 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.
    • Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. Consider an alternative, selective assay for normetanephrine.
    • Discontinue APRISO at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
    • Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad spectrum sun screen outdoors.
    • Cases of nephrolithiasis have been reported with the use of mesalamine, Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment with APRISO.
    • 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. OR Please see 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