Make maintenance of remission your mission with APRISO
For the maintenance of remission of ulcerative colitis
APRISO is a type of medication called a 5-aminosalicylate, or 5-ASA, an antiinflammatory medication that reduces irritation of the colon. APRISO is a once-daily 5-ASA that features INTELLICOR™ delayed- and extended-release delivery for the maintenance of remission of ulcerative colitis (UC) in adults.1
Studies show APRISO provides extended relief from key UC symptoms for up to 6 months, including
- Rectal bleeding
- Diarrhea
- Flare-ups
Features include
- Once-daily dosing: You take APRISO only once a day. It can be taken with or without meals1
- Extended once-daily protection: APRISO provides protection and maintains remission of ulcerative colitis up to 6 months with a 1.5-g once-daily dose1
- Maintenance of remission of UC: In clinical trials, up to 7 out of 10 patients maintained remission for up to 6 months at a 1.5-g once-daily dose1
- Targeting: The delayed- and extended-release delivery releases mesalamine at a pH ≥6, distributing it throughout the colon2
- Savings up to $100 per prescription: The APRISO Savings Card can save you up to $100 on your prescription. Use this free card up to once a month until December 31, 2012, and pay no more than $25 each time*
*You will be required to pay a minimum of $25 of your co-pay or retail cost. You could pay more than $25 if your co-pay or retail cost exceeds $125. Not valid in Massachusetts. Void where prohibited by law. This offer is not valid for prescriptions reimbursed in whole or in part by Medicaid, Medicare, or federally or state-funded programs.
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.