UCERIS rectal foam helped significantly more patients achieve remission, reaching up to 40 cm beyond the anal verge1,3

Significantly more patients achieved remission at week 6 as measured by MMDAI1

STUDY 1: 38.3% vs 25.8% (UCERIS rectal foam [n=133] vs placebo [n=132], respectively), P=.032

STUDY 2: 44.0% vs 22.4% (UCERIS rectal foam [n=134] vs placebo [n=147], respectively), P<.001

Remission as measured by MMDAI1

  • Rectal bleeding score of 0*
  • Endoscopy score of ≤1†
  • Decrease or no change in stool frequency

MMDAI, Modified Mayo Disease Activity Index.

How UCERIS Rectal Foam Works in the Colon

STUDY DESIGN: Two identically designed, randomized, double-blind, placebo-controlled, multicenter studies were conducted in 546 adult patients with an endoscopy-confirmed diagnosis of active, mild to moderate distal colitis with disease extending at least 5 cm, but no further than 40 cm, from the anal verge. Primary endpoint was the proportion of patients who were in remission after 6 weeks of treatment.1

*Rectal bleeding score criteria: 0=no blood seen; 1=blood streaks in stool less than half of the time; 2=blood streaks in stool half the time or more; 3=blood alone passed.1,5

†Endoscopy score criteria: 0=normal/inactive disease; 1=erythema, decreased vascular pattern; 2=marked erythema, absent vascular pattern, friability, erosions; 3=spontaneous bleeding, ulceration.1

UCERIS rectal foam is a targeted therapy1,4

  • No clinically significant differences were observed with respect to the overall percentages of patients with any glucocorticoid-related effects1,3
  • Since UCERIS rectal foam is a glucocorticosteroid, general warnings concerning glucocorticosteroids should be followed
  • Cortisol levels returned to baseline by week 6 for patients taking UCERIS rectal foam1,3

UCERIS rectal foam was designed to stay in place6

UCERIS rectal foam is designed with small volume and high viscosity, which promotes adhesion to the mucosal lining and helps minimize the potential for post-application leakage.6

INDICATION

UCERIS® (budesonide) rectal foam is indicated for the induction of remission in patients with active, mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

IMPORTANT SAFETY INFORMATION—UCERIS rectal foam
  • UCERIS rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of UCERIS rectal foam. Reactions have included anaphylaxis
  • When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Since UCERIS rectal foam contains a glucocorticosteroid, general warnings concerning glucocorticoids should be followed
  • Monitor patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS rectal foam, 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 rectal foam
  • Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. More serious or even fatal courses of chickenpox or measles can occur in susceptible patients. 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
  • Monitor 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
  • The contents of UCERIS rectal foam are flammable. Instruct the patient to avoid fire, flame and smoking during and immediately following administration
  • Patients should temporarily discontinue use of UCERIS rectal foam before initiation of bowel preparation for colonoscopy
  • In clinical studies, the most common adverse reactions of UCERIS rectal foam (occurring in ≥2% of UCERIS patients and at a higher incidence than placebo) were decreased blood cortisol (17%), adrenal insufficiency (4%), and nausea (2%)
  • Advise female patients that UCERIS rectal foam may cause fetal harm and they should inform their healthcare provider about a known or suspected pregnancy
  • The active ingredient of UCERIS rectal foam, budesonide, is metabolized by CYP3A4. Inhibitors of CYP3A4 activity (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, and grapefruit juice) can increase systemic budesonide concentrations. Avoid concomitant use of CYP3A4 inhibitors with UCERIS rectal foam
  • Patients with moderate to severe hepatic impairment should be monitored for increased signs and/or symptoms of hypercorticism. Discontinuing the use of UCERIS rectal foam should be considered in these patients if signs of hypercorticism are observed

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information for UCERIS rectal foam.

References: 1. UCERIS rectal foam [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. Langholz E, Munkholm P, Davidsen M, Nielsen OH, Binder V. Changes in extent of ulcerative colitis: a study on the course and prognostic factors. Scand J Gastroenterol. 1996;31(3):260-266. 3. Sandborn WJ, Bosworth B, Zakko S, et al. Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. Gastroenterology. 2015;148(4):740-750. 4. Brunner M, Vogelsang H, Greinwald R, et al. Colonic spread and serum pharmacokinetics of budesonide foam in patients with mildly to moderately active ulcerative colitis. Aliment Pharmacol Ther. 2005;22(5):463-470. 5. US Department of Health and Human Services. Ulcerative colitis: clinical trial endpoints: guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ulcerative-colitis-clinical-trial-endpoints-guidance-industry. Published August 2016. Accessed December 2, 2020. 6. Gross V, Bar-Meir S, Lavy A, et al. Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis. Aliment Pharmacol Ther. 2006;23(2):303-312.

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.

See more
INDICATION

UCERIS® ((budesonide) rectal foam is indicated for the induction of remission in patients with active, mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

IMPORTANT SAFETY INFORMATION—UCERIS rectal foam
  • UCERIS rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of UCERIS rectal foam. Reactions have included anaphylaxis
  • When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Since UCERIS rectal foam contains a glucocorticosteroid, general warnings concerning glucocorticoids should be followed