UCERIS (budesonide) rectal foam

UCERIS (budesonide) rectal foam

UCERIS (budesonide) rectal foam UCERIS (budesonide) rectal foam

UCERIS rectal foam is a glucocorticosteroid designed to target mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

Indication for UCERIS rectal foam

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 about UCERIS rectal foam

UCERIS (budesonide) 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. Monitor for withdrawal symptoms and unmasking of allergies.

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Monitor 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.

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.

Concomitant use of inhibitors of Cytochrome P450 3A4 (for example ketoconazole and erythromycin) should be avoided and patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Avoid grapefruit juice, which is known to inhibit CYP3A4, when taking UCERIS rectal foam.

Based on animal data, UCERIS rectal foam may cause fetal harm.

Patients with moderate to severe hepatic impairment should be monitored for increased signs and/or symptoms of hypercorticism.

In clinical studies, the most common adverse reactions (incidence ≥2%) were decreased blood cortisol, adrenal insufficiency, and nausea.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for UCERIS rectal foam. pdf

Marketed and distributed by Salix Pharmaceuticals, Inc. under license from Dr. Falk Pharma.

The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.

UCERIS is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

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