For healthcare professionals
Help your adult patients maintain ulcerative colitis remission with once-daily APRISO
APRISO is a locally acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in patients 18 years of age and older.
- Maintains time in remission1
- Proven to maintain remission for up to 6 months in 2 clinical trials
- INTELLICOR™ delayed- and extended-release delivery1,2
- Provides coverage throughout the colon
- 1.5-g once-daily dose1
- Can be taken with or without meals
- APRISO has extensive formulary coverage2
- Transition to an affordable option for your patients
APRISO maintains time in remission for your patients with UC
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 (SDAI).
In a combined analysis (APRISO, n=373; placebo, n=189)—including withdrawals due to UC treatment failure only—of 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. Relapse was defined as a rectal bleeding subscale score of ≥1 and a mucosal appearance score of ≥2 on the SDAI.
Transition to APRISO with confidence
78% of patients with UC who transitioned from other 5-aminosalicylates (5-ASAs) to APRISO maintained remission up to 6 months3
Patients with UC who maintained remission at 6 months after transitioning to APRISO from other 5-ASAs
A post hoc analysis of 2 identically designed, prospective, randomized, double-blind, placebo-controlled, 6-month, multicenter trials was conducted in 487 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 APRISO (granulated mesalamine) and placebo, respectively.2
APRISO features INTELLICORTM delayed- and extended-release delivery for coverage throughout the colon1,2
- A daily dose of APRISO releases granules that dissolve at pH ≥6, for a delayed release of mesalamine
- As intestinal fluid is absorbed, granules swell and form channels through which mesalamine is delivered in an extended release
- The delayed- and extended-release INTELLICOR™ delivery system provides once-daily protection throughout the colon
Explore the INTELLICORTM delivery system
Proven tolerability in a once-daily dose
APRISO is well tolerated, with most adverse events reported as mild to moderate in severity1
APRISO is pregnancy category B.1
IMPORTANT SAFETY INFORMATION
APRISO is a locally acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older. APRISO is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates (sulfasalazine) or to any of the components of APRISO capsules. 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. The recommended dose of APRISO is four 0.375-g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame, equivalent to 2.24 mg of phenylalanine per day. In 2 well-controlled clinical trials, the most common treatment-related adverse events occurring in at least 3% of adult patients taking 1.5 g/day of APRISO and at a rate greater than placebo were headache (11% vs 8% for placebo), diarrhea (8% vs 7% for placebo), upper abdominal pain (5% vs 3% for placebo), nausea (4% vs 3% for placebo), nasopharyngitis (4% vs 3% for placebo), influenza and influenza-like illness (4% vs 4% for placebo), and sinusitis (3% vs 3% for placebo).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch/ or call
1-800-FDA-1088.
Complete Prescribing Information
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
E-mail: Salix@medcomsol.com
References: 1. APRISO [prescribing information]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2008. 2. Data on file, Salix Pharmaceuticals, Inc. 3. Lichtenstein GR, Merchant K, Shaw A, Yuan J, Bortey E, Forbes W. Once-daily 1.5-g granulated mesalamine effectively maintains remission in patients with ulcerative colitis who switch from different 5-ASA formulations. Abstract presented at: American College of Gastroenterology Annual Scientific Meeting; October 3-8, 2008; Orlando, FL.