Full prescribing information
UCERIS® (budesonide) extended release tablets are designed to provide extended release of budesonide in the colon, in a time-dependent manner, 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 target delivery of budesonide throughout the full length of the colon.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
  • Budesonide has high topical activity1
  • Topical potency of 15x that of prednisolone, the active metabolite of prednisone1
  • Budesonide has 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 (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 versus 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 versus 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 20154

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 occurred at similar rates with UCERIS 9-mg tablets and placebo at 8 weeks1
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 occurred at similar rates for UCERIS 6 mg and placebo at 12 months1
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.

Emily H||

Physical Exam

Temp: 97.6°F

BP: 110/72 mm Hg

UCDAI Score: 5

Laboratory Results

CBC/Differential: Within normal limits

ESR/CRP: 20 mm/hr; 4 mg/dL

CrCL : 125 mL/min

LFT panel: Within normal limits

Lipid panel: Within normal limits

Stool test:(-) Escherichia coli;
(-) Clostridium difficile; (-) RBC

Pregnancy test: hCG level:<5mlU/mL; negative

Background

Emily is a 29-year-old entrepreneur who owns a catering business and travels frequently for personal deliveries. She is newly married and is looking forward to her next vacation with her husband.

Chief Complaints

Fatigue, nausea, abdominal pain with mild diarrhea, unexplained weight loss.

Past Medical History

  • Anemia

Current Medications

  • Iron
  • Vitamin B12 supplement

Treatment Decision

  • Colonoscopy reveals that Emily has mildly active UC
  • Emily will be started on one UCERIS 9-mg tablet daily in the morning for up to 8 weeks to induce remission
  • Emily prefers taking oral medication with her busy travel schedule
BP = blood pressure; CBC = complete blood count; CrCL = creatinine clearance; CRP = c-reactive protein; ESR = erythrocyte sedimentation rate; hCG = human chorionic gonadotropin; LFT = liver function test; RBC = red blood cells; Temp = temperature; UC = ulcerative colitis; UCDAI = Ulcerative Colitis Disease Activity Index.
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.

Ray S||

Physical Exam

Temp: 98.6°F

BP: 140/82 mm Hg

UCDAI Score: 8

Laboratory Results

CBC/Differential:

Hgb: 12.1 g/dL;

WBC > 10,000 cells/mL

ESR/CRP: 25 mm/hr; 8 mg/dL

CrCL: 102 mL/min

LFT panel: Within normal limits

Lipid panel:

TC: 174 mmol/L

TG: 155 mmol/L

HDL: 45 mmol/L

LDL: 98 mmol/L

Stool test: (-) Escherichia coli; (-) Clostridium difficile; (+) RBC

Background

Ray is a 52-year-old insurance agent who works long hours. He likes to eat out and drink socially.

Chief Complaints

Abdominal pain and diarrhea a few times per day for the past 2 weeks. These symptoms had occurred briefly a few months prior to the office visit, but resolved on their own. Recently, streaks of blood in his stools have been noted more frequently.

Past Medical History

  • UC (diagnosed at age 33)
  • Hyperlipidemia
  • GERD

Current Medications

  • Statin
  • OTC proton pump inhibitor
  • Multivitamin

Treatment Decision

  • Colonoscopy confirmed marked erythema and erosions; biopsy confirms moderately active UC
  • Ray will be started on one UCERIS 9-mg tablet daily in the morning for up to 8 weeks to induce remission
  • Ray's doctor advised him to keep a food diary to see what foods might affect symptoms and to limit stress as much as possible
BP = blood pressure; CBC = complete blood count; CrCL = creatinine clearance; CRP = c-reactive protein; ESR = erythrocyte sedimentation rate; GERD = gastroesophageal reflux disease; hCG = human chorionic gonadotropin; HDL = high density lipoprotein; Hgb = hemoglobin; LDL = low density lipoprotein; LFT = liver function test; OTC = over-the-counter; RBC = red blood cells; TC = total cholesterol; Temp = temperature; TG = triglycerides; UC = ulcerative colitis; UCDAI = Ulcerative Colitis Disease Activity Index; WBC = white blood cell count.
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, Inc. 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
WARNINGS
AND PRECAUTIONS:
 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, Inc, a division of Valeant Pharmaceuticals North America.
REFERENCES
  1. UCERIS [prescribing information]. Raleigh, NC: Salix Pharmaceuticals, Inc.; 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. 2005;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 Feb;132(2):763-86.

© 2015 Salix Pharmaceuticals, Inc. / Santarus, Inc.

UCE-US-0008 3/15


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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