UCERIS TABLETS: ONCE-DAILY DOSING
- One 9-mg tablet taken orally once daily in the morning for up to 8 weeks1
- With or without food1
- UCERIS tablets should be swallowed whole and not chewed, crushed, or broken1
|Strength||UCERIS 9 mg|
|Package Size||30 tablets|
SELECTED IMPORTANT SAFETY INFORMATION
- Concomitant use of inhibitors of Cytochrome P450 3A4 (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin) should be avoided and patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Advise patients to avoid ingestion of grapefruit and grapefruit juice, which is known to inhibit CYP3A4, when taking UCERIS tablets
A BUDESONIDE WITH MMX® TECHNOLOGY
Budesonide has up to 90% first-pass metabolism, and no clinically significant differences were observed with respect to the overall percentages of patients with any glucocorticoid-related effects between UCERIS and placebo after 8 weeks of induction therapy.1 However, since UCERIS tablets are a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.
The clinical effect of drug delivery on outcome is unknown.
UCERIS tablets are enteric coated to resist dissolution in the stomach, and do not dissolve until exposure to pH ≥7 in the terminal ileum of the small intestine. After reaching the colon, the tablet matrix expands, forms a hydrogel, and provides extended release of budesonide in a time-dependent manner. UCERIS tablets have been detected by scintigraphic imaging in the ascending colon between 4 and 24 hours after dosing.1,3
SELECTED IMPORTANT SAFETY INFORMATION
- Care is needed in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS tablets, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients. Taper patients slowly from systemic corticosteroids if transferring to UCERIS tablets
The efficacy of UCERIS tablets was assessed in two randomized, double-blind, placebo-controlled studies. The studies were conducted in a total of 970 adult patients with active, mild to moderate UC.1,4
Primary endpoint: Combined clinical and endoscopic remission at 8 weeks.
UCERIS extended release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of UCERIS.
Two similar drug trials studied a total of 970 adult patients with active, mild to moderate UC. Each trial consisted of 2 groups: one group was given UCERIS tablets and the other was given sugar pills (placebo). Participants had an Ulcerative Colitis Disease Activity Index (UCDAI) score that was equal to or higher than 4, but less than or equal to 10. UCDAI measures UC with a total score of 0 to 12, based on frequency of bowel movements, rectal bleeding, appearance of the colon, and the physician’s rating of disease activity. Remission was defined as a UCDAI score of less than or equal to 1.1,4
Profile of steroid-related safety at 8 weeks1†
†In a pooled analysis of 2 Phase III clinical trials.
- In clinical studies, the most common adverse reactions of UCERIS tablets (occurring in ≥2% of UCERIS patients and at a higher incidence than placebo) were headache (11%), nausea (5%), decreased blood cortisol (4%), upper abdominal pain (4%), fatigue (3%), flatulence (2%), abdominal distension (2%), acne (2%), urinary tract infection (2%), arthralgia (2%), and constipation (2%)
Since UCERIS tablets are a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.
Study design: Two randomized, double-blind, placebo-controlled studies were conducted in a total of 970 adult patients with active, mild to moderate UC (UCDAI: ≥4 and ≤10 at entry). The primary endpoint was induction of combined clinical and endoscopic remission (defined as a UCDAI score of ≤1, with subscores of 0 for both rectal bleeding and stool frequency, normal mucosa with no friability on endoscopy, and a ≥1-point reduction in the EI score) after 8 weeks of treatment.1,4