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Uceris

Generic Name: budesonide

Date of Approval:

  • Extended Release Tablets - January 14, 2013
  • Rectal Foam - October 7, 2014
Company: Santarus, Inc.

Treatment for: Ulcerative Colitis

FDA Approves Uceris

The U.S. Food and Drug Administration (FDA) has approved Uceris (budesonide) extended release tablets, a prescription corticosteroid for the induction of remission in patients with active, mild to moderate ulcerative colitis. It is taken once daily in the morning with or without food for up to 8 weeks.

The U.S. Food and Drug Administration has also approved Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge. The foam formulation overcomes treatment limitations associated with currently approved oral therapies which are often ineffective due to insufficient distribution of active drug to the distal colon.

Uceris Extended-Release Tablets Patient Information

What is Uceris?

Uceris is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis (UC) under control (induce remission).

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

It is not known if Uceris is safe and effective in children.

Who should not take Uceris?

Do not take Uceris if:

  • you are allergic to budesonide or any of the ingredients in Uceris. See the end of this leaflet for a complete list of ingredients in Uceris.

What should I tell my healthcare provider before taking Uceris?

Before you take Uceris tell your healthcare provider if you:

  • have liver problems
  • are planning to have surgery
  • have chicken pox or measles or have recently been near anyone with chicken pox 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)
  • stomach ulcers
  • any other medical condition
  • are pregnant or plan to become pregnant. It is not known if Uceris will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Uceris can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take Uceris or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter vitamins, and herbal supplements. Uceris and other medicines may affect each other causing side effects.

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?

  • Take Uceris exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how many Uceris to take.
  • Take Uceris in the morning.
  • Take Uceris tablets whole with water. Do not chew, crush, or break the tablets before swallowing.
  • If you take too much of Uceris, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid?

  • Do not eat grapefruit or drink grapefruit juice while taking Uceris. Eating grapefruit or drinking grapefruit juice can increase the level of Uceris in your blood.

Uceris side effects

Uceris can cause some serious side effects, including:

  • Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-time use of Uceris 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 is 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 including:
    • tiredness
    • vomiting
    • weakness
    • low blood pressure
    • nausea
  • Immune system effects and a higher chance of infections. Uceris 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 chicken pox or measles, while taking Uceris.

    Tell your healthcare provider about any signs or symptoms of infection during treatment with Uceris, 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 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.

The most common side effects of Uceris 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. 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.

See also: Side effects (in more detail)

How should I store Uceris?

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

Keep Uceris and all medicines out of the reach of children.

General Information about Uceris

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Uceris for a condition for which it was not prescribed. Do not give Uceris to other people, even if they have the same symptoms you have. It may harm them.

If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Uceris that is written for health professionals.

For more information go to www.Uceris.com or call (1-888-778-0887).

What are the ingredients in Uceris?

Active Ingredients: budesonide

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

Uceris Rectal Foam Patient Information

What is Uceris Rectal Foam?

Uceris rectal foam is a prescription corticosteroid medicine used to help get mild to moderate active ulcerative colitis that extends from the rectum to the sigmoid colon under control (induce remission).

It is not known if it is safe and effective in children.

Who should not use Uceris Rectal Foam?

Do not use this preparation if you are allergic to budesonide or any of the ingredients listed at the end of this patient information leaflet.

Before using Uceris Rectal Foam

Before you use this medication, tell your healthcare provider if you:

  • have liver problems
  • are planning to have surgery
  • have chicken pox or measles or have recently been near anyone with chicken pox 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)
  • stomach ulcers
  • any other medical condition
  • are pregnant or plan to become pregnant. It is not known if the rectal foam will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Uceris rectal foam can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will use the rectal foam 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 rectal foam 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 use Uceris Rectal Foam?

See the Instructions for Use that comes with your prescription for detailed information about the right way to use the rectal foam.

  • Use the rectal foam exactly as your healthcare provider tells you to use it.
  • The rectal foam should only be used rectally (through the anus). Do not take the rectal foam by mouth.
  • Warm the Uceris rectal foam canister by holding it in your hands while shaking it for 10 to 15 seconds.
  • Uceris rectal foam is used twice a day for the first TWO weeks of treatment (in the morning and in the evening). After TWO weeks, use Uceris rectal foam ONCE a day in the evening, before bedtime for FOUR weeks.
  • If you use too much rectal foam, call your healthcare provider right away.
  • You should stop using Uceris rectal foam before preparing for a colonoscopy. Call your healthcare provider before restarting treatment after your colonoscopy.

What should I avoid?

  • Do not eat grapefruit or drink grapefruit juice while using Uceris rectal foam. Eating grapefruit or drinking grapefruit juice can increase the level of budesonide (the active ingredient in the rectal foam) in your blood.
  • Uceris rectal foam is flammable. Avoid fire, flame and smoking during and right after using the rectal foam.

Uceris Rectal Foam side effects

Uceris rectal foam may cause serious side effects, including:

  • Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-time use of Uceris rectal foam 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 rectal foam is used for a long period of time (chronic use), the adrenal glands may 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 including:
    • tiredness
    • weakness
    • nausea
    • vomiting
    • low blood pressure
  • Immune system effects and a higher chance of infections. Uceris rectal foam may 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 chicken pox or measles during treatment.

    Tell your healthcare provider about any signs or symptoms of infection during treatment including:
    • fever
    • chills
    • aches
    • feeling tired
    • pain
    • nausea or vomiting
  • Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to Uceris rectal foam may cause your allergies to come back. These allergies may include eczema (a skin disease) or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while using Uceris rectal foam.

The most common side effects include:

  • decreased blood cortisol levels
  • adrenal insufficiency
  • nausea

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

This list does not cover all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may also report side effects to FDA at 1-800-FDA-1088.

How should I store Uceris rectal foam?

  • Store the rectal foam at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Do not store the rectal foam container near heat or store at temperatures above 120°F (49°C).
  • Do not puncture or burn the foam canister.
  • Do not refrigerate.

Keep all medicines out of the reach of children.

General Information

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medication for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Uceris rectal foam?

Active ingredients: budesonide

Inactive ingredients: cetyl alcohol, citric acid monohydrate, edetate disodium, emulsifying wax, polyoxyl (10) stearyl ether, propylene glycol, and purified water

Propellant: n-butane, isobutane, and propane

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