Frequently asked questions about APRISO

General APRISO information

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What is APRISO and how does it work?

APRISO is an ulcerative colitis (UC) treatment that contains mesalamine, a type of medication that reduces inflammation in the colon. It is a once-daily delayed- and extended-release medication that can be taken with or without meals. APRISO is indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older.

How often do I take APRISO?

Just once a day.

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

You can take APRISO with or without meals. It passes through the stomach without affecting absorption or effectiveness.

Can I take other medications with APRISO?

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. You should not take APRISO with antacids. Your doctor will tell you which other medications you may or may not take with APRISO.

What safety concerns should I know about?

For safety information, please see the Important Safety Information for APRISO as well as the full Prescribing Information.

Should I continue to take APRISO even if I begin to feel better?

Even if you begin to feel better, you should consult your physician before discontinuing the use of any prescription medication, including APRISO. APRISO is a once-daily medication that can be taken with or without meals.

Medication savings offer

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Are there special offers for savings with APRISO?

Yes. APRISO offers the APRISO Savings Card, which 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.*

Can I print out an APRISO Savings Card online?

Yes. If you did not receive an APRISO Savings Card from your doctor, you can get your card here.

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 Savings Card, 6501 Weston Pkwy, Suite 370, Cary, NC 27513.

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.

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 InformationPDF

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

*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.