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
- 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