Uceris (Page 4 of 5)

14 CLINICAL STUDIES

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 ≥4 and ≤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 UCERIS 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 ≤1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥1 point reduction in an endoscopy-only score.2 In both studies, UCERIS 9 mg extended-release tablets demonstrated superiority to placebo in inducing remission (Table 4).

Table 4. Induction of Remission in Studies 1 and 2

Treatment Group

Study 1 n/N (%)

Study 2 n/N (%)

UCERIS 9 mg

22/123 (17.9)

19/109 (17.4)

UCERIS 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 UCERIS 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 ≤1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥1 point reduction in an endoscopy-only score.2

The primary analysis population included only patients that had histology consistent with active UC.

CI=Confidence Interval

*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 UCERIS 9 mg vs. placebo in both Studies 1 and 2 based on the Chi-square test (alpha=0.025)

15 REFERENCES

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.

16 HOW SUPPLIED/STORAGE AND HANDLING

UCERIS® (budesonide) extended-release tablets 9 mg are white, round, biconvex tablets and debossed with “MX9”. They

are supplied as follows:

NDC 68012-309-30 Bottles of 30 tablets

Store at 25°C to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room

Temperature].

Keep container tightly closed. Protect from light and moisture.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients being treated with UCERIS 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 UCERIS.

Hypercorticism and Adrenal Suppression

Patients should be advised that UCERIS extended-release tablets may cause systemic glucocorticosteroid effects of hypercorticism and adrenal suppression. Patients should taper slowly from systemic corticosteroids if transferring to UCERIS extended-release tablets [see Warnings and Precautions (5.1) and (5.2)].

Immunosuppression

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 UCERIS Extended-Release Tablets

UCERIS 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 UCERIS therapy [see Dosage and Administration (2)].

Pregnancy

Advise female patients that UCERIS may cause fetal harm and to inform their healthcare provider with a known or

suspected pregnancy [see Use in Specific Populations (8.1)].

Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC

Bridgewater, NJ 08807 USA

By:

Cosmo S.p.A.

Milan, 20020 Italy

By license of Cosmo Technologies Ltd., Dublin, Ireland

U.S. Patent Numbers: 7,410,651; 7,431,943; 8,293,273; 8,784,888; 8,895,064; 9,132,093; 9,192,581; 9,320,716;

9,532,954; 9,592,203 and RE43799

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

© 2020 Salix Pharmaceuticals, Inc. or its affiliates

Patient Information

UCERIS (u SAIR us)

(budesonide)

extended release tablets

What are UCERIS extended release tablets?

UCERIS extended release tablets are a prescription corticosteroid medicine used to help get active mild to moderate ulcerative colitis (UC) under control (induce remission).

It is not known if UCERIS extended release tablets are safe and effective in children.

Who should not take UCERIS extended release tablets?

Do not take UCERIS extended release tablets if:

you are allergic to budesonide or any of the ingredients in UCERIS extended release tablets. See the end of this leaflet for a complete list of ingredients in UCERIS extended release tablets.

What should I tell my healthcare provider before taking UCERIS extended release tablets?

Before you take UCERIS extended release tablets tell your healthcare provider about all of your medical conditions, including if you:

have liver problems.
are planning to have surgery.
have chickenpox or measles or have recently been near anyone with chickenpox or measles.
have an infection.
have or had a family history of diabetes, cataracts or glaucoma.
have or had tuberculosis.
have high blood pressure (hypertension).
have decreased bone mineral density (osteoporosis).
have stomach ulcers.
are pregnant or plan to become pregnant. UCERIS extended release tablets may harm your unborn baby. Tell your healthcare provider if you are pregnant or think you are pregnant.
are breastfeeding or plan to breastfeed. UCERIS extended release tablets can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take UCERIS extended release tablets or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. UCERIS 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.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take UCERIS extended release tablets?

Take UCERIS extended release tablets exactly as your healthcare provider tells you to take them.
Take UCERIS extended release tablets 1 time each day in the morning with or without food.
Take UCERIS extended release tablets whole with water. Do not chew, crush, or break UCERIS extended release tablets before swallowing.
If you take too much of UCERIS extended release tablets, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid while taking UCERIS extended release tablets?

Do not eat grapefruit or drink grapefruit juice while taking UCERIS extended release tablets. Eating grapefruit or drinking grapefruit juice can increase the level of UCERIS extended release tablets in your blood.

What are the possible side effects of UCERIS extended release tablets?

UCERIS extended release tablets may cause some serious side effects, including:

Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-time use of UCERIS extended release tablets can cause you to have too much glucocorticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism:
acne
bruise easily
rounding of your face (moon face)
ankle swelling
thicker or more hair on your body and face
a fatty pad or hump between your shoulders (buffalo hump)
pink or purple stretch marks on the skin of your abdomen, thighs, breasts and arms
Adrenal suppression. When UCERIS extended release tablets are taken for a long period of time (chronic use), the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression during treatment with UCERIS extended release tablets including:
tiredness
weakness
nausea
vomiting
low blood pressure
Immune system effects and a higher chance of infections.

UCERIS extended release tablets weaken your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chickenpox or measles, while taking UCERIS extended release tablets.

Tell your health care provider about any signs or symptoms of infection during treatment with UCERIS extended release tablets, including:

fever
pain
aches
chills
feeling tired
nausea and vomiting
Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to UCERIS extended release tablets may cause your allergies to come back. These allergies may include eczema (a skin disease) or rhinitis (inflammation inside your nose). Tell your healthcare provider if any of your allergies become worse while taking UCERIS extended release tablets.

The most common side effects of UCERIS extended release tablets include:

headache
nausea
decreased blood cortisol levels
stomach-area pain
tiredness
stomach or intestinal gas
bloating
acne
urinary tract infection
joint pain
constipation

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 UCERIS extended release tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store UCERIS extended release tablets?

Store UCERIS extended release tablets at room temperature, between 68°F to 77°F (20°C to 25°C).
Keep the bottle tightly closed to protect UCERIS extended release tablets from light and moisture.

Keep UCERIS extended release tablets and all medicines out of the reach of children.

General information about the safe and effective use of UCERIS extended release tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use UCERIS extended release tablets for a condition for which it was not prescribed. Do not give UCERIS 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 UCERIS extended release tablets that is written for health professionals.

For more information go to www.UCERIS.com or call 1-800-321-4576.

What are the ingredients in UCERIS extended release tablets?

Active Ingredient: budesonide

Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributed by:

Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA

By:

Cosmo S.p.A. Milan, 20020 Italy

By license of Cosmo Technologies Ltd., Dublin, Ireland

U.S. Patent Numbers: 7,410,651; 7,431,943; 8,293,273; 8,784,888; 8,895,064; 9,132,093; 9,192,581; 9,320,716; 9,532,954; 9,592,203 and RE43799

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

© 2020 Salix Pharmaceuticals, Inc. or its affiliates

Revised: 04/2020

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