Experts Discuss UCERIS® (budesonide) rectal foam

UCERIS rectal foam is a glucocorticosteroid 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. In this video roundtable series, Marla Dubinsky, MD, sits down with David Hudesman, MD, and Simon Lichtiger, MD, to discuss topics including left-sided symptoms of ulcerative colitis, patient quality of life, and the importance of rectal therapy. The panel also reviews their own experiences prescribing UCERIS rectal foam, the clinical data behind UCERIS, and how to discuss this treatment option with patients.

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Video 1: The Right Fit for Rectal Therapy

In this video, the panelists discuss which patients with left-sided ulcerative colitis can benefit the most from rectal therapy and how to explain treatment options to these patients. Please click here for full Prescribing Information for UCERIS rectal foam.

Up Next

Video 1: The Right Fit for Rectal Therapy
Video 2: Reach Beyond the Rectum with UCERIS rectal foam
Video 3: UCERIS rectal foam in Review

About the Panel

Marla Dubinsky, MD

  • Co-Director, Susan and Leonard Feinstein IBD Clinical Center
  • The Mount Sinai Hospital

David Hudesman, MD

  • Co-Director, Inflammatory Bowel Disease Center, NYU Langone Health
  • Associate Professor of Medicine, NYU School of Medicine

Simon Lichtiger, MD

  • Professor of Gastroenterology, Columbia University Medical Center

Disclosures

This roundtable was produced by the Custom Programs division of Frontline Medical Communications.

The faculty received modest honoraria from Frontline Medical Communications and Salix Pharmaceuticals for their participation in this roundtable.

All faculty maintain ongoing relationships with Salix Pharmaceuticals.

Uceris is a trademark of Salix Pharmaceuticals or its affiliates.

© 2019 Salix Pharmaceuticals or its affiliates.

The Uceris Indication and Important Safety Information were provided by Salix Pharmaceuticals.

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.

  • 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
  • Care is needed in 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%)
  • 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
  • There are no adequate and well controlled studies with UCERIS rectal foam in pregnant women. UCERIS rectal foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use of UCERIS rectal foam is likely to result in budesonide in human milk. Exercise caution when administering UCERIS rectal foam to a nursing woman
  • 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.

Based on: 9499001, Rev. 09/2016