Full Prescribing Information
UCERIS® (budesonide) extended release tablets are designed to provide time-dependent release of budesonide in the colon, using multi-matrix (MMX®) technology.
UCERIS® (budesonide) tablets provide extended release of budesonide in the colon, in a time-dependent manner.1-3
  • UCERIS is enteric coated to protect from dissolution in the stomach. The tablet core provides extended release of budesonide in the colon, in a time-dependent matter1,3
  • Coating dissolves at pH ≥71

MMX technology is designed to provide extended release of budesonide in the colon, in a time-dependent manner.2,3

Important Safety Information

UCERIS 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.

UCERIS® (budesonide) tablets:
Potency and pharmacokinetic profile
  • High topical activity1
  • Topical potency of 15x that of prednisolone, the active metabolite of prednisone1
  • Limited systemic glucocorticoid activity1
  • Up to 90% first-pass metabolism1

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 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.

UCERIS® (budesonide) tablets are effective in inducing clinical and endoscopic remission in patients with active, mild to moderate ulcerative colitis (UC)4

Important Safety Information

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.

The CORE studies combined two measures of remission
  • Two randomized, double-blind, placebo-controlled trials (CORE I and CORE II) in 899 adult patients with active, mild to moderate UC1,2,4,5,*

Baseline disease severity

Active UC

Patients beginning the study had:

  • Active, mild to moderate UC (Ulcerative Colitis Disease Activity Index [UCDAI] score between 4 and 10)4
  • A median baseline UCDAI score of 7 on a scale of 0-121
  • No concomitant treatment on entering the studies and through completion4
  • The CORE studies required the stringent primary endpoint of clinical remission plus endoscopic remission1
  • 1) Ulcerative Colitis Disease Activity Index (UCDAI)†:
  • UCDAI score of ≤1, with subscores of 0 for both rectal bleeding and stool frequency1
  • A normal mucosa (with no evidence of friability) by endoscopy1
  • 2) Rachmilewitz Endoscopic Index (EI):
  • A ≥1-point reduction in the EI score from baseline4
  • 4-component score (total score 0-12) composed of granulation, vascular pattern, vulnerability of mucosa, and mucosal damage6
UCDAI at study entry was ≥4 and ≤10.
UCDAI is a 4-component scale (total score of 0-12) that is composed of clinical assessments of stool frequency, rectal bleeding, mucosal appearance, and physician's rating of disease activity, with scores of 0-3 for each component.1

Primary endpoint

Remission of UC

Combined clinical and endoscopic
remission at week 81,4

Endoscopic images are not from study patients.

Important Safety Information

Patients with moderate to severe liver disease should be monitored for increased signs and/or symptoms of hypercorticism.

UCERIS® (budesonide) tablets: Efficacy†

IN STUDY 1

UCERIS 9 mg induced remission in 17.9% of patients (n/N; 22/123) compared with 7.4% (9/121) of patients taking placebo at 8 weeks (P=0.0143)1,5

IN STUDY 2

UCERIS induced remission in 17.4% (19/109) of patients vs 4.5% (4/89) of placebo-treated patients at 8 weeks (P=0.005)1,2

  • Three times more patients taking UCERIS achieved clinical and endoscopic remission vs placebo4
PRIMARY ENDPOINT: COMBINED CLINICAL AND
ENDOSCOPIC REMISSION AT 8 WEEKS IN A POOLED ANALYSIS OF THE TWO CORE STUDIES
18%
6%

Sources: UCERIS Prescribing Information1; Sandborn 2015.4

Important Safety Information

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® (budesonide) tablets:
Adverse Event Profile
  • Overall glucocorticosteroid-related side effects for UCERIS and placebo at 8 weeks were 10.2% and 10.5%, respectively1,‡
GLUCOCORTICOID-RELATED SIDE EFFECTS
WITH UCERIS 9 MG AND PLACEBO‡
10.2
10.5
3.5
4.3
2.7
4.7
2.4
3.1
2.4
1.9
1.2
1.6

Source: UCERIS Prescribing Information.1

In a pooled analysis of 2 Phase III trials.
Glucocorticoid-related side effects of UCERIS® (budesonide) tablets 6 mg from a 12-month safety study
  • Overall glucocorticoid-related side effects for UCERIS 6 mg and placebo at 12 months were 14.5% vs 11.5%, respectively1
GLUCOCORTICOID-RELATED SIDE EFFECTS
WITH UCERIS 6 MG AND PLACEBO
14.5
11.5
6.5
3.3
4.8
4.9
6.5
6.6
4.8
0
4.8
4.9

Source: UCERIS Prescribing Information.1

  • The recommended dosage for the induction of remission in adult patients with active, mild to moderate UC is one 9-mg tablet to be taken once daily for up to 8 weeks1
  • The UCERIS long-term safety data were evaluated in a placebo-controlled 12-month study and used the 6-mg dose. The 6-mg dose is not available in the United States1
  • Normal bone density was reported in 77% (27/35) and 74% (29/39) of patients taking UCERIS 6 mg and placebo, respectively1

Important Safety Information

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.

Greg H§

23-year-old graduate student

Mild UC

Diagnosed 2 years ago

Disease Presentation

  • Two to three bowel movements per day
  • Abdominal discomfort
  • Frequent bowel urgency
  • Intermittent streaks of blood in stool

Clinical History

  • Symptoms generally controlled with maintenance mesalamine
  • Experienced flaring UC symptoms that required additional treatment
  • Wanted to control his UC flare, but was concerned about steroid side effects

Treatment Decision

  • Greg prefers taking oral medication due to his busy school schedule
  • Greg will be started on one UCERIS 9-mg tablet daily in the morning for 8 weeks to induce remission
Fictitious patient. This case study is not intended to instruct any healthcare provider in the treatment of any illness nor is it meant to substitute for medical training or to be relied upon in treating any individual patient.

Diana S§

34-year-old real estate broker

Moderate UC

Diagnosed 15 years ago

Disease Presentation

  • Four to five bowel movements per day
  • Obvious blood in stool
  • Abdominal pain
  • Mucosal inflammation with friability apparent on endocopy

Clinical History

  • Treated with mesalamine for maintenance of UC since diagnosis
  • Tried several courses of other treatments for active disesase; discontinued and unwilling to repeat
  • UC flares were becoming more disruptive
  • Did not want to advance to treatment with biologics

Treatment Decision

  • Diana will be started on one UCERIS 9-mg tablet daily in the morning for 8 weeks to induce remission
  • Diana's doctor advised her to limit stress as much as possible and to keep a food diary to see what foods might affect her symptoms
Fictitious patient. This case study is not intended to instruct any healthcare provider in the treatment of any illness nor is it meant to substitute for medical training or to be relied upon in treating any individual patient.

Important Safety Information

UCERIS 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.

UCERIS® (budesonide) TABLETS
ARE A LOW-COST OPTION
Most eligible patients
with commercial insurance
will pay only
$25||
Some restrictions apply. Please see the eVoucherRx™ and Instant Savings Card Program brochure for Terms and Conditions. Salix Pharmaceuticals reserves the right to modify or cancel these offerings at any time.
MPR MONOGRAPH
Company:
 Santarus, Inc.
Pharmacologic
class:
 Glucocorticosteroid
Active
IngRedient:
 Budesonide 9 mg; extended release tablets
Indication:
 Induction of remission in patients with active, mild to moderate ulcerative colitis
Adults:
 Swallow whole. 9 mg once daily in the AM for up to 8 weeks
Children:
 Not established
Contraindications:
 Known hypersensitivity to budesonide or any of the ingredients in UCERIS tablets
SAFETY CONSIDERATIONS:
 Hypercorticism and adrenal suppression. Supplement with systemic glucocorticosteroid in surgery or other stress situations. Caution when transferring from steroids with high systemic availability (monitor). May unmask allergies previously controlled by systemic corticosteroids. Immunosuppression. Potential worsening of infections. Active or quiescent tuberculosis, untreated fungal, bacterial, systemic viral or parasitic infections. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Hypertension. Diabetes. Osteoporosis. Peptic ulcer. Glaucoma. Cataracts. Moderate-to-severe liver disease: monitor for hypercorticism; consider discontinuing. Elderly. Pregnancy (Cat. C). Nursing mothers: not recommended
Interactions:
 May be potentiated by CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin); consider discontinuing. Avoid grapefruit or grapefruit juice. May be affected by gastric acid reducing agents (eg, PPIs, H2-blockers, antacids)
Adverse reactions:
 Headache, nausea, decreased blood cortisol, upper abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia, constipation
How Supplied:
 Tablets—30/bottle
Santarus, Inc. is a wholly owned subsidiary of Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America.
REFERENCES
  1. UCERIS [prescribing information]. Raleigh, NC: Salix Pharmaceuticals; 2013.
  2. Travis SP, 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.
  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. D'Haens G, Sandborn WJ, Feagan BG, et al. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007;132(2):763-786.

© 2015 Valeant Pharmaceuticals North America LLC.

All rights reserved.

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This MPR Prescribing Alert is produced as a basic reminder of important information for healthcare professionals. Readers are advised to consult manufacturers and specialists if questions arise about specific products, treatments, or diseases. The publisher and editors do not assume liability for any errors or omissions. MPR and MPR Prescribing Alert are registered trademarks of Haymarket Media, Inc.

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