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For Active, Mild to Moderate Ulcerative Colitis (UC)
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UCERIS®
(budesonide)
extended release tablets
Power your
patients
can handle
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MMX® technology targets delivery of budesonide throughout
the full length of the colon1,2
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UCERIS is uniquely designed for targeted local action at the
entire site of UC1-3
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UCERIS is indicated for the treatment of active, mild to moderate UC; it is not indicated for the treatment of Crohn’s disease.1
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Budesonide, a highly potent corticosteroid, is rapidly metabolized and therefore must be delivered to its desired site of action for optimal effect4
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UCERIS is locally acting, dissolving at pH >7.0, the approximate pH level near entry to the colon1,3
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Controlled ileal release (CIR) budesonide
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CIR budesonide targets the ileum and/or ascending colon, dissolving at pH >5.5–the approximate pH of the duodenum.
CIR budesonide is indicated for the treatment of active, mild to moderate Crohn’s disease involving the ileum and/or ascending colon;
it is not indicated for the treatment of UC.5
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The clinical effect of this information is unknown.
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3 times more patients taking UCERIS achieved combined clinical remission AND mucosal healing compared with placebo6*
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www.UCERIS.com
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Rates of overall expected glucocorticoid-related side effects were similar for UCERIS and placebo at 8 weeks—10.2% vs 10.5%, respectively1* |
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UCERIS has a convenient treatment regimen, dosed as a single daily tablet1 |
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Most patients with commercial insurance will pay only $25 for UCERIS† |
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INDICATION
UCERIS® is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
DOSAGE AND ADMINISTRATION
The recommended dosage of UCERIS is one 9-mg tablet to be taken once daily in the morning with or without food for up to 8 weeks.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
UCERIS is contraindicated in patients with known hypersensitivity to budesonide or any of the ingredients of UCERIS.
WARNINGS AND PRECAUTIONS
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Hypercorticism and adrenal suppression: Since UCERIS is a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.
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Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids with high systemic effects. Taper patients slowly from systemic corticosteroids if transferring to UCERIS.
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Immunosuppression: Potential worsening of infections (eg, existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
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Increased systemic glucocorticoid susceptibility: Reduced liver function affects the elimination of glucocorticosteroids.
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Other glucocorticoid effects: Caution should be taken in patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where glucocorticosteroids may have unwanted effects. |
ADVERSE REACTIONS
Most common adverse reactions (incidence >2%) are headache, nausea, decreased blood cortisol, upper abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia, and constipation.
DRUG INTERACTIONS
Avoid Cytochrome P450 3A4 inhibitors (eg, ketoconazole, grapefruit juice). May cause increased systemic corticosteroid effects.
USE IN SPECIFIC POPULATIONS
Hepatic impairment: Monitor patients for signs and/or symptoms of hypercorticism.
This Important Safety Information does not include all of the information needed to use UCERIS safely and effectively. See Full Prescribing Information for additional information.
*In a pooled analysis of 2 Phase III studies.1,6
†Some restrictions apply. Please see the eVoucherRx™ and Instant Savings Card Program brochure for Terms and Conditions. Santarus reserves the right to modify or cancel these offerings at any time.
References: 1. UCERIS Prescribing Information. Santarus, Inc. January 2013. 2. Brunner M, Ziegler S, Di Stefano AF, et al. Gastrointestinal transit, release and plasma pharmacokinetics of a new oral budesonide formulation. Br J Clin Pharmacol. 2005;61:31-38. 3. Press AG, Hauptmann IA, Hauptmann L, et al. Gastrointestinal pH profiles in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 1998;12:673-678. 4. Sandborn WJ, Travis S, Moro L, et al. Once-daily budesonide MMX® extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012;143:1218-1226. 5. Entocort Prescribing Information. AstraZeneca AB. 2011. 6. Data on file. Santarus, Inc.
UCERIS is a registered trademark of Santarus, Inc.
MMX is a registered trademark of Cosmo Technologies, Ltd.
eVoucherRx™ is a trademark of RelayHealth.
© 2013 Santarus, Inc. 1-UCE13225 July 2013
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