(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
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
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
- have decreased bone mineral
- 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
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
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:
- bruise easily
- rounding of your face (moon
- 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:
- 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 while using UCERIS
Tell your healthcare provider
about any signs or symptoms of infection during treatment with UCERIS rectal
- feeling tired
- 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
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
- 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
UCERIS 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
This Patient Information has
been approved by the U.S. Food and Drug Administration.
Instructions for Use
( 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.
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
- 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).
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
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).
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).
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.
Step 6: Insert the Applicator into Rectum
Insert the applicator into your rectum as far as it is
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).
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).
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).
Step 9: Remove the Applicator (See Figure J)
The foam will still expand a little and may drop out of
the applicator or anus.
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.
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).
Wash your hands with soap and water. Try not to empty
your bowels until the next morning.
This Instructions for Use has been approved by the U.S.
Food and Drug Administration.