UCERIS® (budesonide) extended release tablets
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New Formulary Coverage and Expanded Savings ProgramUCERIS:
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  MMX Technology   MMX® technology targets delivery of budesonide throughout the entire site of ulcerative colitis1-3  
 
  3 times more patients taking UCERIS achieved combined clinical remission AND mucosal healing compared with placebo4*

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.

 
  Rates of overall expected glucocorticoid-related side effects were similar for UCERIS and placebo at 8 weeks—10.2% vs 10.5%, respectively1*

 
  UCERIS has a convenient treatment regimen, dosed as a single daily tablet1

 
  UCERIS Savings   Through the UCERIS Savings Program, now 90% of patients will pay only $254†‡  
  www.UCERIS.com

UCERIS (budesonide) extended release tablets
  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
Hypercorticism and adrenal suppression: Since UCERIS is a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.

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.

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.

Increased systemic glucocorticoid susceptibility: Reduced liver function affects the elimination of glucocorticosteroids.

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.1,4
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.
Source: RelayHealth, June 2013.

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. 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.

SANTARUS, INC. (R)  
© 2013 Santarus, Inc. 1-UCE13409 September 2013