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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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Pharmacy Corner

UCERIS TABLETS: ONCE-DAILY DOSING

  • One 9-mg tablet taken orally once daily in the morning for up to 8 weeks1
  • With or without food1
  • UCERIS tablets should be swallowed whole and not chewed, crushed, or broken1

Not actual size.

Strength UCERIS 9 mg
NDC Number 68012-309-30
Package Size 30 tablets

SELECTED IMPORTANT SAFETY INFORMATION

  • 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


A BUDESONIDE WITH MMX® TECHNOLOGY

Budesonide has up to 90% first-pass metabolism, and no clinically significant differences were observed with respect to the overall percentages of patients with any glucocorticoid-related effects between UCERIS and placebo after 8 weeks of induction therapy.1 However, since UCERIS tablets are a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.

The clinical effect of drug delivery on outcome is unknown.

UCERIS tablets are enteric coated to resist dissolution in the stomach, and do not dissolve until exposure to pH ≥7 in the terminal ileum of the small intestine. After reaching the colon, the tablet matrix expands, forms a hydrogel, and provides extended release of budesonide in a time-dependent manner. UCERIS tablets have been detected by scintigraphic imaging in the ascending colon between 4 and 24 hours after dosing.1,3

SELECTED IMPORTANT SAFETY INFORMATION

  • 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

Efficacy

The efficacy of UCERIS tablets was assessed in two randomized, double-blind, placebo-controlled studies. The studies were conducted in a total of 970 adult patients with active, mild to moderate UC.1,4

Primary endpoint: Combined clinical and endoscopic remission at 8 weeks.

UCERIS extended release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of UCERIS.

Study design

Two similar drug trials studied a total of 970 adult patients with active, mild to moderate UC. Each trial consisted of 2 groups: one group was given UCERIS tablets and the other was given sugar pills (placebo). Participants had an Ulcerative Colitis Disease Activity Index (UCDAI) score that was equal to or higher than 4, but less than or equal to 10. UCDAI measures UC with a total score of 0 to 12, based on frequency of bowel movements, rectal bleeding, appearance of the colon, and the physician’s rating of disease activity. Remission was defined as a UCDAI score of less than or equal to 1.1,4

Safety profile

Profile of steroid-related safety at 8 weeks1†

†In a pooled analysis of 2 Phase III clinical trials.

  • 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%)

Since UCERIS tablets are a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.


Study design: Two randomized, double-blind, placebo-controlled studies were conducted in a total of 970 adult patients with active, mild to moderate UC (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 subscores of 0 for both rectal bleeding and stool frequency, normal mucosa with no friability on endoscopy, and a ≥1-point reduction in the EI score) after 8 weeks of treatment.1,4

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, and erythromycin) should be avoided. Advise patients to also avoid ingestion of grapefruit and grapefruit juice, which are 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 1-800-321-4576 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: 1-800-321-4576
Email: salixmc@dlss.com

References: 1. UCERIS tablets [Prescribing Information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. US Food and Drug Administration. Drugs at FDA Web site. https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=UCERIS. Accessed May 12, 2016. 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. 4. Sandborn WJ, Danese S, D’Haens G, et al. Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative colitis with budesonide MMX 9 mg: pooled analysis of two phase 3 studies. Aliment Pharmacol Ther. 2015;41(5):409-418. 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(5):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. Gut. 2014;63(3):433-441.

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