Induction of Remission in Active, Mild to Moderate Ulcerative Colitis
Two similarly designed, randomized, double-blind, placebo-controlled studies were conducted in a total of 970 adult patients with active, mild to moderate ulcerative colitis (UC) which was defined as an Ulcerative Colitis Disease Activity Index (UCDAI of greater than or equal to 4 and less than or equal to 10). Eight hundred ninety-nine of these patients had histology consistent with active UC; this was considered the primary analysis population. UCDAI is a four-component scale (total score of 0 to 12) that encompasses the clinical assessments of stool frequency, rectal bleeding, mucosal appearance and physician’s rating of disease activity (score of 0 to 3 for each of the components).
The baseline median UCDAI score in both studies was 7.
In Study 1, 56% of patients were male, and the median age was 42 years. In Study 2, 57% of patients were male, and the median age was 44 years. In Study 1, 50% of patients were Caucasian, 7% were African American, and 34% were Asian. In Study 2, more than 99% were Caucasian.
Both studies compared budesonide extended-release tablets 9 mg and 6 mg with placebo and included an active reference arm (a mesalamine 2.4 g in Study 1 and a budesonide* 9 mg not approved for the treatment of UC in Study 2). The primary endpoint was induction of remission after 8 weeks of treatment. Remission was defined as a UCDAI score of less than or equal to 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a greater than or equal to 1 point reduction in an endoscopy-only score.2 In both studies, budesonide extended-release tablets 9 mg demonstrated superiority to placebo in inducing remission (Table 4).
|Treatment Group||Study 1 n/N (%)||Study 2 n/N (%)|
|Budesonide Extended-Release Tablets 9 mg||22/123 (17.9)||19/109 (17.4)|
|Budesonide Extended-Release Tablets 6 mg||16/121 (13.2)||9/109 (8.3)|
|Reference arm*||15/124 (12.1)||13/103 (12.6)|
|Placebo||9/121 (7.4)||4/89 (4.5)|
|Treatment difference between Budesonide Extended-Release Tablets 9 mg and placebo (95% CI) †||10.4% (2.2%, 18.7%)||12.9% (4.6%, 21.3%)|
Remission is defined as a UCDAI score of less than or equal to 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a greater than or equal to 1 point reduction in an endoscopy-only score.2
The primary analysis population included only patients that had histology consistent with active UC.
* The reference arm in Study 1 is a delayed release mesalamine 2.4 g; the reference arm in Study 2 is a budesonide 9 mg not approved for the treatment of UC.
† p<0.025 for budesonide extended-release tablets 9 mg vs. placebo in both Studies 1 and 2 based on the Chi-square test (alpha = 0.025)
1. Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. BMJ. 1989;298:82-6.
Budesonide extended-release tablets 9 mg, are white, round, biconvex, film-coated tablets imprinted with “WPI ” and “2510 ” on one side and plain on the other. Tablets are supplied in bottles of 30, NDC 0591-2510-30.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Keep container tightly closed. Protect from light and moisture.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Patients being treated with budesonide extended-release tablets should receive the following information and instructions. This information is intended to aid the patient in the safe and effective use of budesonide extended-release tablets.
Hypercorticism and Adrenal Suppression
Patients should be advised that budesonide extended-release tablets may cause systemic glucocorticosteroid effects of hypercorticism and adrenal suppression. Patients should taper slowly from systemic corticosteroids if transferring to budesonide extended-release tablets [see Warnings and Precautions (5.1) and (5.2)].
Patients who are on immunosuppressant doses of glucocorticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician immediately. If exposure to such a person occurs, and the patient has not had chickenpox or been properly vaccinated, a physician should be consulted immediately. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex [see Warnings and Precautions (5.3)].
How to Take Budesonide Extended-Release Tablets
Budesonide extended-release tablets should be swallowed whole with water and NOT CHEWED, CRUSHED, OR BROKEN. Patients should be advised to avoid the consumption of grapefruit juice for the duration of their budesonide extended-release tablets therapy [see Dosage and Administration (2)].
Advise female patients that budesonide extended-release tablets may cause fetal harm and to inform their healthcare provider with a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Rev. A 6/2020
PATIENT INFORMATION Budesonide (bue des′ oh nide) Extended-Release Tablets
What are budesonide extended-release tablets?
| Who should not take budesonide extended-release tablets? |
Do not take budesonide extended-release tablets if:
|What should I tell my healthcare provider before taking budesonide extended-release tablets? |
Before you take budesonide extended-release tablets tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Budesonide extended-release tablets and other medicines may affect each other causing side effects.
Especially tell your healthcare provider if you take another medicine that contains corticosteroids for other conditions, such as allergies or asthma.
How should I take budesonide extended-release tablets?
What should I avoid while taking budesonide extended-release tablets?
What are the possible side effects of budesonide extended-release tablets?
Budesonide extended-release tablets may cause serious side effects, including:
| || |
| || |
| || |
| || |
| || |
| || |
| || |
| || |
| || |
| || |
|Tell your healthcare provider if you have any side effect that bothers you or that does not go away. |
These are not all the possible side effects of budesonide extended-release tablets. For more information, ask your healthcare provider or pharmacist.
| How should I store budesonide extended-release tablets? |
|General information about the safe and effective use of budesonide extended-release tablets. |
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use budesonide extended-release tablets for a condition for which it was not prescribed. Do not give budesonide extended-release tablets to other people, even if they have the same symptoms you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about budesonide extended-release tablets that is written for health professionals.
What are the ingredients in budesonide extended-release tablets?
Active ingredient: budesonide, USP
Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2910, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid copolymer types A and B, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, propylene glycol, sodium starch glycolate Type A, soy lecithin powder, talc, titanium dioxide, and triethyl citrate.
Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA
Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA
|This Patient Information has been approved by the U.S. Food and Drug Administration. Rev. A 6/2020|
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.