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Uceris

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Uceris

PATIENT INFORMATION

Instructions for Use

UCERIS
(u SAIR us) (budesonide) rectal foam

Read the Patient Information and Instructions for Use that comes with UCERIS rectal foam before you start using it. Talk to your healthcare provider if you have any questions.

Before using UCERIS rectal foam, you should use the bathroom to empty your bowels.

You may use UCERIS rectal foam while in a standing position, in a lying position, or in a sitting position (for example, while using the toilet).

Applicators should be used only 1 time. You should use a new applicator for each dose.

Figure A

Contents of Kit - Illustration

Each kit contains (See Figure A):

  • Complete Prescribing Information
  • Patient Information and Instructions for Use
  • 2 canisters containing 14 doses each 4 trays of single-use applicators (7 applicators per tray)
  • Applicator disposal bags for use after each dose

Preparing to use UCERIS rectal foam

Step 1: Twist Safety Tab to Remove

Before the first use, remove the safety tab from under the pump dome (See Figure B).

Figure B

Remove the safety tab - Illustration

The canister cannot be used if safety tab is not removed.

Step 2: Attach the Applicator

The applicators are in a special tray. Hold the tray firmly and pull to remove 1 applicator.

Push the applicator firmly onto the nozzle of the canister (See Figure C).

Each applicator is coated with a lubricant. If needed, you can apply an additional lubricant, such as Vaseline® (petrolatum, petroleum jelly).

Figure C

Push the applicator firmly onto the nozzle of the canister - Illustration

Step 3: Align Notch to Nozzle

To unlock the canister, twist the dome on the top of the canister until the semi-circular notch underneath the dome is in line with the nozzle (See Figure D).

Figure D

Unlock the canister - Illustration

Step 4: Warm and Shake Canister

Warm the canister by holding it in your hands while shaking it vigorously for 10 to 15 seconds (See Figure E).

Figure E

Warm the canister by holding it in your hands while shaking it vigorously - Illustration

Step 5: Turn the Canister Upside Down

Place your forefinger on the top of pump dome and then turn the canister upside down (See Figure F).

The canister will only work properly when held with the pump dome pointing down.

Figure F

Turn the Canister Upside Down - Illustration

Step 6: Insert the Applicator into Rectum

Insert the applicator into your rectum as far as it is comfortable.

The easiest way to use UCERIS rectal foam is to keep one foot on the floor and raise the other foot onto a firm surface such as a chair or stool (See Figure G).

Figure G

Insert the Applicator into Rectum - Illustration

Step 7: Give a Dose of UCERIS Rectal Foam

To give a dose of UCERIS rectal foam, use your forefinger to fully push down the pump dome one time and hold it for about 2 seconds in that position (See Figure H).

Figure H

Give a Dose of UCERIS Rectal Foam -  Illustration

Step 8: Release and Hold

Release finger pressure on the pump dome and hold the applicator in place for 10 to 15 seconds (See Figure I).

Figure I

Hold the applicator in place for 10 to 15 seconds - Illustration

Step 9: Remove the Applicator (See Figure J)

The foam will still expand a little and may drop out of the applicator or anus.

Figure J

Remove the Applicator - Illustration

Step 10: Remove Applicator from Canister

Remove the applicator from the canister and place the used applicator in the plastic bag provided. (See Figure K). Throw the plastic bag away in your household trash.

Figure K

Place the used applicator in the plastic bag provided- Illustration

Step 11: Twist Notch on Dome Away from Nozzle

To prevent loss of UCERIS rectal foam from the canister between uses, turn the pump dome around so that the semi-circular notch faces the opposite direction to the nozzle (See Figure L).

Figure L

Twist Notch on Dome Away from Nozzle - Illustration

Wash your hands with soap and water. Try not to empty your bowels until the next morning.

UCERIS
(u SAIR us)
(budesonide) rectal foam

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 UCERIS rectal foam is safe and effective in children.

Who should not use UCERIS rectal foam?

Do not use UCERIS rectal foam if you are allergic to budesonide or any of the ingredients in UCERIS rectal foam. See the end of this leaflet for a complete list of ingredients in UCERIS rectal foam.

What should I tell my healthcare provider before using UCERIS rectal foam?

Before you use UCERIS rectal foam, 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 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 UCERIS 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” at the end of this Patient Information for detailed information about the right way to use UCERIS rectal foam.

  • Use UCERIS rectal foam exactly as your healthcare provider tells you to use it.
  • UCERIS rectal foam should only be used rectally (through the anus). Do not take UCERIS 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 2 weeks of treatment (in the morning and in the evening). After 2 weeks, use UCERIS 1 time a day in the evening, before bedtime for 4 weeks.
  • If you use too much UCERIS 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 UCERIS rectal foam after your colonoscopy.

What should I avoid while using UCERIS rectal foam?

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

What are the possible side effects of UCERIS rectal foam?

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 with UCERIS rectal foam including:
  • 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 while using UCERIS rectal foam.

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

These are not all the possible side effects of UCERIS rectal foam. 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 UCERIS rectal foam at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Do not store the UCERIS rectal foam container near heat or store at temperatures above 120°F (49°C).
  • Do not puncture or burn the UCERCIS rectal foam canister.
  • Do not refrigerate.

Keep UCERIS rectal foam and all medicines out of the reach of children.

General Information about UCERIS rectal foam

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use UCERIS rectal foam for a condition for which it was not prescribed. Do not give UCERIS rectal foam 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 about UCERIS rectal foam. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about UCERIS rectal foam that is written for health professionals.

For more information, go to www.UCERIS.com.

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

Last reviewed on RxList: 11/17/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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