Uceris (Page 4 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

UCERIS rectal foam is supplied as a kit containing 2 aerosol canisters with 28 PVC applicators coated with paraffin lubricant for administration of the foam (NDC 65649-651-03). Each canister (NDC 65649-651-02) is labeled with a net weight of 33.4 g and contains 14 metered doses.

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Handling

UCERIS rectal foam contains a flammable propellant. Do not have the canister burned after use and do not spray contents directly towards flames.

Do not expose to heat or store at temperatures above 120°F (49°C).
Flammable. Avoid fire, flame, or smoking during and immediately following administration.
Contents under pressure. Do not puncture or incinerate.

DO NOT REFRIGERATE.

17 PATIENT AND COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)

Administration

Advise patients:

UCERIS rectal foam is only to be applied rectally. It is not for oral use.
Before using UCERIS rectal foam, use the bathroom to empty your bowels.
Each applicator is coated with a lubricant. If additional lubrication is needed, petrolatum or petroleum jelly can also be used.
Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use.
UCERIS rectal foam can be used in a standing, lying or sitting position (e.g., while using the toilet).
Apply UCERIS rectal foam in the morning and the evening for the first 2 weeks of treatment; then once daily in the evening for the next 4 weeks. When applied in the evening, use immediately prior to bedtime. Try not to empty your bowels again until the next morning.
Avoid consumption of grapefruit or grapefruit juice during treatment with UCERIS rectal foam.
Avoid fire, flame, and smoking during and immediately following administration since UCERIS rectal foam is flammable.

Hypercorticism and Adrenal Suppression

Advise patients that UCERIS rectal foam may cause hypercorticism and adrenal suppression and that they should taper slowly from systemic corticosteroids if transferring to UCERIS rectal foam [see Warnings and Precautions (5.1) ,(5.2)]. Advise patients that replacement of systemic glucocorticosteroids with UCERIS rectal foam may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug.

Increased Risk of Infection

Advise patients to avoid exposure to people with chicken pox or measles and if exposed, consult a physician. Also, inform patients that they are at increased risk of developing a variety of infections, including worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex and to contact their physician if they develop any symptoms of infection [see Warnings and Precautions (5.3)].

Manufactured for:

Salix Pharmaceuticals, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

Product marketed and distributed under license from Dr. Falk Pharma.

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

© Valeant Pharmaceuticals North America LLC

9499001

Revised: 09/2016

Patient Information

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) .
have stomach ulcers.
have 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:
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 while using UCERIS rectal foam.
Tell your healthcare provider about any signs or symptoms of infection during treatment with UCERIS rectal foam, including:
fever
aches
pain
chills
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
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° to 77°F (20° 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.

Manufactured for:
Salix Pharmaceuticals, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

Product marketed and distributed under license from Dr. Falk Pharma.

Uceris is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

© Valeant Pharmaceuticals North America LLC

9499001

Revised: 09/2016

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