UCERIS rectal foam is a glucocorticosteroid, formulated with budesonide, that's uniformly delivered to the distal colon, where it extends up to 40 cm from the anal verge to help patients with active, mild to moderate distal UC achieve remission.1,2
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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 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 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 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 foam are flammable. Instruct the patient to avoid fire, flame and smoking during and immediately following administration.
- Patients should temporarily discontinue use of UCERIS 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%).
- Concomitant use of inhibitors of Cytochrome P450 3A4 (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine and grapefruit juice) should be avoided and patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Advise patients to avoid grapefruit and grapefruit juice, which is known to inhibit CYP3A4, when taking UCERIS foam.
- UCERIS foam may cause fetal harm. Discontinue in nursing mothers after taking into account the importance of the drug to the mother.
- Patients with moderate to severe hepatic impairment should be monitored for increased signs and/or symptoms of hypercorticism. Discontinuing the use of UCERIS 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.
For product information and product complaint reports, please contact:
Salix Product Information Call Center
here for full Prescribing Information for UCERIS rectal foam.
References: 1. UCERIS rectal foam [Prescribing Information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. 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. 3. 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.
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