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For patients with active, For patients with active,

UCERIS TABLETS DELIVER STEROID POWER FOR COMPLETE UC RELIEF

For patients with active, For patients with active,

UCERIS TABLETS DELIVER STEROID POWER FOR COMPLETE UC RELIEF

For patients with active, For patients with active,

UCERIS TABLETS DELIVER STEROID POWER FOR COMPLETE UC RELIEF

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UCERIS extended release tablets are a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

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Most eligible commercially insured patients may pay no more than $25 for each UCERIS tablets prescription.*

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MMX® technology allows for the extended release of budesonide.

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ABOUT UCERIS TABLETS

UCERIS tablets with MMX® technology: Extended release of budesonide in the colon1

  • UCERIS tablets contain budesonide—a steroid with high topical activity
  • Topical potency 15x that of prednisolone, the active metabolite of prednisone
  • Budesonide has up to 90% first-pass metabolism
  • In clinical trials, overall glucocorticoid effects were similar to placebo over 8 weeks of induction therapy

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.

UCERIS tablets use MMX® technology.2 The tablets are enteric coated to prevent dissolution in the stomach, and do not dissolve until they reach pH ≥7 in the terminal ileum of the small intestine.1,3

After reaching the colon, the tablet matrix expands, providing extended release of budesonide in a time-dependent manner.1 UCERIS tablets have been detected by scintigraphic imaging in the ascending colon between 4 and 24 hours after dosing.3

 

UCERIS tablets distribution at 7 hours postrelease.

Image enhanced for presentation purposes. Image is from 1 healthy individual and does not necessarily correspond to clinical effects in patients with active, mild to moderate UC.

The clinical effect of drug delivery on outcome is unknown.

UCERIS tablets with MMX® technology provide extended release of budesonide in the colon, in a time-dependent manner.1,3

View Pharmacoscintigraphic Image

UCERIS is a single 9-mg tablet taken once daily in the morning by mouth for up to 8 weeks.1

SELECTED IMPORTANT SAFETY INFORMATION

  • UCERIS extended release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of UCERIS tablets. Anaphylactic reactions have occurred with other budesonide formulations
  • Care is needed in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS tablets, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients. Taper patients slowly from systemic corticosteroids if transferring to UCERIS tablets

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INDICATION

UCERIS® (budesonide) extended release tablets are a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

IMPORTANT SAFETY INFORMATION—UCERIS extended release tablets

  • UCERIS extended release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of UCERIS tablets. Anaphylactic reactions have occurred with other budesonide formulations.
  • When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Since UCERIS 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 tablets, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients. Taper patients slowly from systemic corticosteroids if transferring to UCERIS 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 courses of chickenpox or measles can occur in susceptible patients.
  • 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.
  • In clinical studies, the most common adverse reactions of UCERIS tablets (occurring in ≥2% of UCERIS patients and at a higher incidence than placebo) were headache (11%), nausea (5%), decreased blood cortisol (4%), upper abdominal pain (4%), fatigue (3%), flatulence (2%), abdominal distension (2%), acne (2%), urinary tract infection (2%), arthralgia (2%), and constipation (2%).
  • Concomitant use of inhibitors of Cytochrome P450 3A4 (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin) should be avoided and patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Advise patients to avoid ingestion of grapefruit and grapefruit juice, which is known to inhibit CYP3A4, when taking UCERIS tablets.
  • Since the dissolution of the coating of UCERIS tablets is pH dependent, the release properties and uptake of the compound may be altered when UCERIS tablets are used after treatment with gastric acid–reducing agents (eg, PPIs, H2-blockers and antacids).
  • There are no adequate and well-controlled studies in pregnant women. Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is secreted in human milk. A decision should be made whether to discontinue nursing or to discontinue UCERIS tablets, taking into account the clinical importance of UCERIS tablets to the mother.
  • Patients with moderate to severe liver disease should be monitored for increased signs and/or symptoms of hypercorticism. Discontinuing the use of UCERIS tablets should be considered in these patients.

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-508-0024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information for UCERIS extended release tablets.

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salixmc@dlss.com

References: 1. UCERIS tablets [Prescribing Information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. 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(5):1218-1226. 3. 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. 2006;61(1):31-38.

*Some restrictions apply. Please click here for full eligibility criteria, terms and conditions. Salix Pharmaceuticals reserves the right to modify or cancel these offerings at any time.

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The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

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Salix Pharmaceuticals
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UCERIS is a trademark of Salix Pharmaceuticals or its affiliates.
MMX is a trademark of Cosmo Technologies Limited used under license.
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UCE.0050.USA.16    February 2017.

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