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PRESCRIBING INFORMATION

FOR HEALTHCARE PROFESSIONALS

UC Medications and Treatments

Bringing Medications for the Treatment of UC to Life.

While there is currently no cure for ulcerative colitis (UC), medications are available to help reduce the inflammation and relieve symptoms, allowing the colon to heal. The goal of all UC medications is to help patients reach — and maintain — remission.

Medications used to treat UC are:

Aminosalicylates (5-ASA): This class of anti-inflammatory drugs is typically used to treat mild to moderate UC symptoms, and help prevent relapses. They include sulfasalazine and also oral formulations of mesalamine, such as APRISO. Side effects are usually mild.
Corticosteroids: Also known as steroids, drugs such as prednisone, methylprednisolone and hydocortisone also reduce inflammation and are used to treat moderate to severely active UC. Corticosteroids suppress the immune system, and are not recommended for long-term use because of significant side-effects.
Immune modifiers: Immune modifiers are sometimes called immunomodulators. These drugs are used to help decrease corticosteroid usage. They lessen the inflammatory response caused by UC by working on the body's immune system.
Biologic therapies: Biologic therapies are the newest class of drugs used for people suffering from moderate to severely active ulcerative colitis. These drugs are made from antibodies that bind with certain molecules to block a particular action. Biologic drugs are administered by injection or infusion. Because biologic drugs target only specific "pathways" involved with UC, they may have fewer side effects.

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. 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 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).

For complete Prescribing Information, please click here.