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Indication:
UCERIS® (budesonide) extended release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Important Safety Information: UCERIS® (budesonide) extended release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of UCERIS. When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Since UCERIS extended release tablets are a glucocorticosteroid, general warnings concerning glucocorticoids should be followed. Care is needed in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS extended release tablets, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Taper patients slowly from systemic corticosteroids if transferring to UCERIS extended release tablets. Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Patients with moderate to severe liver disease should be monitored for increased signs and/or symptoms of hypercorticism. 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. Concomitant use of inhibitors of Cytochrome P450 3A4 (for example ketoconazole and erythromycin) should be avoided and patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Avoid grapefruit juice, which is known to inhibit CYP3A4, when taking UCERIS. In clinical studies, the most common adverse reactions (incidence >2%) were headache, nausea, decreased blood cortisol, upper abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia, and constipation. Please see complete Prescribing Information for UCERIS extended release tablets. *In a pooled analysis of 2 Phase III studies. CORE study designs: Two randomized, double-blind, placebo-controlled studies were conducted in a total of 899 adult patients with active, mild to moderate UC (Ulcerative Colitis Disease Activity Index [UCDAI]: >4 and <10 at entry). The primary endpoint was induction of combined clinical and endoscopic remission (defined as a UCDAI score of <1, with scores of 0 for both rectal bleeding and stool frequency, normal mucosa with no friability on endoscopy, and a >1-point reduction in the Endoscopic Index [EI] score) after 8 weeks of treatment.1,5,6 References: 1. UCERIS Prescribing Information. Salix Pharmaceuticals, 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. Data on file. Salix Pharmaceuticals, Inc. 4. US Food and Drug Administration. Drugs at FDA Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed January 24, 2014. 5. 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. 6. Travis SPL, Danese S, Kupcinskas L, et al. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study [published online ahead of print February 22, 2013]. Gut. http://gut.bmj.com/content/early/2013/02/21/gutjnl-2012-304258.full.pdf. Accessed February 3, 2014. UCERIS is a registered trademark of Santarus, Inc., a wholly owned subsidiary of Salix Pharmaceuticals, Inc. MMX is a registered trademark of Cosmo Technologies, Ltd. 
© 2014 Salix Pharmaceuticals, Inc. / Santarus, Inc. UCE36-0114 |
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