UCERIS with MMX® technology: The power of locally acting budesonide
UCERIS is a locally acting corticosteroid that treats patients with active, mild to moderate ulcerative colitis (UC).
UCERIS uses MMX® technology, which targets delivery of budesonide throughout the full length of the colon. Targeted delivery is possible because UCERIS does not dissolve until it reaches the colon. The tablet is coated with a gastro-resistant film that only dissolves after exposure to a pH ≥7, which is when it normally reaches the terminal ileum, near the entry to the colon.
After reaching the colon, the pill matrix expands, forms a hydrogel, and provides extended release of budesonide in a time-dependent manner. Budesonide has been detected by scintigraphic imaging in the ascending colon between 4 and >24 hours after dosing. The medication is then absorbed into the body and subject to a high first-pass metabolism (80-90%), thereby minimizing side effects.
Unlike other UC therapies, UCERIS is a single pill taken once a day by mouth for up to 8 weeks. Additional 8-week courses can be given for recurring episodes of active disease.
MMX® technology allows budesonide to target the full length of the colon
UCERIS is uniquely designed for targeted local action at the entire site of UC.
INDICATIONS AND USAGE
UCERIS is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
DOSAGE AND ADMINISTRATION
The recommended dosage of UCERIS is one 9-mg tablet to be taken once daily in the morning with or without food for up to 8 weeks.
IMPORTANT SAFETY INFORMATION
UCERIS is contraindicated in patients with known hypersensitivity to budesonide or any of the ingredients of UCERIS.
WARNINGS AND PRECAUTIONS
- Hypercorticism and adrenal suppression: Since UCERIS is a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.
- Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids with high systemic effects. Taper patients slowly from systemic corticosteroids if transferring to UCERIS.
- Immunosuppression: Potential worsening of infections (eg, existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
- Increased systemic glucocorticoid susceptibility: Reduced liver function affects the elimination of glucocorticosteroids.
- Other glucocorticoid effects: Caution should be taken in 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.
Most common adverse reactions (incidence ≥2%) are headache, nausea, decreased blood cortisol, upper abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia, and constipation.
Avoid Cytochrome P450 3A4 inhibitors (eg, ketoconazole, grapefruit juice). May cause increased systemic corticosteroid effects.
USE IN SPECIFIC POPULATIONS
Hepatic impairment: Monitor patients for signs and/or symptoms of hypercorticism.
The Important Safety Information does not include all the information needed to use UCERIS safely and effectively. See Full Prescribing Information for additional information.
To report a Product Adverse Event or Product Complaint: 1-888-778-0887, Monday-Friday, 9:00 am-7:00 pm Eastern Time
Note: 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.
Reference: Data on file, Santarus, Inc.