Budesonide (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 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).

Table 4. Induction of Remission in Studies 1 and 2
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.

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 budesonide extended-release tablets 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

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.

17 PATIENT COUNSELING INFORMATION

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)].

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 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)].

Pregnancy

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)].

Manufactured by:
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA

Distributed by:
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?

  • Budesonide 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 budesonide extended-release tablets are safe and effective in children.
Who should not take budesonide extended-release tablets?

Do not take budesonide extended-release tablets if:

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

  • 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. Budesonide 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. Budesonide can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take budesonide 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. 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?

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

What should I avoid while taking budesonide extended-release tablets?

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

What are the possible side effects of budesonide extended-release tablets?

Budesonide extended-release tablets may cause serious side effects, including:

  • Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-time use of budesonide 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 budesonide 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 budesonide extended-release tablets including:
  • tiredness
  • vomiting
  • weakness
  • low blood pressure
  • nausea
  • Immune system effects and a higher chance of infections. Budesonide 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 budesonide extended-release tablets.Tell your healthcare provider about any signs or symptoms of infection during treatment with budesonide extended-release tablets, including:
  • fever
  • chills
  • pain
  • feeling tired
  • aches
  • nausea and vomiting
  • Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to budesonide 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 budesonide extended-release tablets.The most common side effects of budesonide extended-release tablets include:
  • headache
  • stomach or intestinal gas
  • nausea
  • bloating
  • decreased blood cortisol levels
  • acne
  • stomach-area pain
  • urinary tract infection
  • tiredness
  • 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 budesonide extended-release tablets. For more information, ask your healthcare provider or pharmacist.

How should I store budesonide extended-release tablets?
  • Store budesonide extended-release tablets at room temperature between 68° to 77°F (20° to 25°C).
  • Keep the bottle tightly closed to protect budesonide extended-release tablets from light and moisture.
Keep budesonide extended-release tablets and all medicines out of the reach of children.
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

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