Uceris (Rectal)

Budesonide rectal foam is used to help control mild to moderate active ulcerative colitis that extends from the rectum to the sigmoid colon (induce remission). Budesonide is a steroid (cortisone-like) medicine.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits for any problems or side effects that may be caused by this medicine.

If your condition does not improve or if it gets worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you experience more than one of these symptoms while using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

If you are taking another steroid medicine and are switching to Uceris®, check with your doctor first. This may increase your chance of having steroid withdrawal side effects, such as headache, loss of appetite, blurred vision, change in the ability to see colors (especially blue or yellow), or vomiting.

You may become more susceptible to infections while using this medicine. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.

Make sure any doctor or dentist treating you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you might have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how budesonide rectal foam affects children. Its safety and effectiveness have not been established. Since budesonide may slow growth in children, those using it for a long time should have their weight and growth checked by their doctor regularly.

Geriatric

Studies have not shown any specific problems in older adults that would limit the usefulness of budesonide rectal foam. However, older patients are more likely to have liver, kidney, or heart problems related to aging, which may require careful monitoring and possible dose adjustments for those taking budesonide rectal foam.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together, even if there may be an interaction. In such cases, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are highlighted for their potential significance but are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may change some of the other medicines you take.

• Desmopressin
• Levoketoconazole
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Aceclofenac
• Acemetacin
• Adagrasib
• Amtolmetin Guacil
• Aspirin
• Atazanavir
• Balofloxacin
• Belzutifan
• Bemiparin
• Besifloxacin
• Boceprevir
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Ciprofloxacin
• Clarithromycin
• Clonixin
• Cobicistat
• Conivaptan
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Duvelisib
• Enoxacin
• Etodolac
• Etofenamate
• Etoricoxib
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Fleroxacin
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Fosnetupitant
• Gatifloxacin
• Gemifloxacin
• Ibuprofen
• Idelalisib
• Indinavir
• Indomethacin
• Itraconazole
• Ivosidenib
• Ketoconazole
• Ketoprofen
• Ketorolac
• Larotrectinib
• Lefamulin
• Lenacapavir
• Levofloxacin
• Lomefloxacin
• Lopinavir
• Lorlatinib
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nefazodone
• Nelfinavir
• Nepafenac
• Netupitant
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nirmatrelvir
• Norfloxacin
• Ofloxacin
• Olutasidenib
• Omaveloxolone
• Oxaprozin
• Oxyphenbutazone
• Pacritinib
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pirtobrutinib
• Posaconazole
• Pranoprofen
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Ritlecitinib
• Ritonavir
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Saquinavir
• Sargramostim
• Sodium Salicylate
• Somatrogon-ghla
• Sparfloxacin
• Sulindac
• Telaprevir
• Telithromycin
• Tenoxicam
• Tiaprofenic Acid
• Tocilizumab
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Trofinetide
• Valdecoxib
• Voriconazole

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both.

• Auranofin
• Erythromycin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used near the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are highlighted for their potential significance but are not a complete list.

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If used together, your doctor may adjust the dose or frequency or provide special instructions regarding food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

Having other medical issues may affect how this medicine works. Make sure to tell your doctor if you have any other health problems, especially:

• Cataracts (eye disease), or a family history of
• Diabetes, or a family history of
• Eczema (skin condition) or
• Glaucoma, or a family history of
• Hypertension (high blood pressure) or
• Infection (e.g., bacteria, virus, fungus) or
• Osteoporosis (thin bones) or
• Rhinitis (inflammation inside your nose) or
• Stomach ulcer, active or history of
• Tuberculosis, active or history of
• Weakened immune system—Use with caution. May worsen these conditions.

• Liver disease (including cirrhosis), moderate to severe—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Darkening of the skin
• diarrhea
• dizziness
• fainting
• loss of appetite
• mental depression
• nausea
• skin rash
• unusual tiredness or weakness
• vomiting

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• blurred vision
• cough or hoarseness
• difficulty swallowing
• fever or chills
• headache
• hives or itching
• itching, scaling, severe redness, soreness, or swelling of the skin
• lower back or side pain
• painful or difficult urination
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• slow or fast heartbeat
• tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Blemishes on the skin
• pimples
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Uceris

Available Dosage Forms:

• Foam

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Adrenal Glucocorticoid

Use this medicine exactly as directed by your doctor. Do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

To use:

• Before using this medicine, it is best to empty your bowels.
• This medicine is to be applied on the anus. Do not take this medicine by mouth.
• Attach the applicator (provided in the package) to the can. Each applicator is coated with a lubricant. If additional lubrication is needed, you may use petrolatum or petroleum jelly.
• Warm the canister foam by shaking it in your hands for 10 to 15 seconds.
• You may use the rectal foam in a standing, lying, or sitting position (eg, while using the toilet).
• Apply the foam in the morning and evening for the first 2 weeks. When applied in the evening, use it before bedtime. Try not to empty bowels until the next morning.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For rectal dosage form (foam):For induction of remission mild to moderate distal ulcerative colitis Adults—One metered dose (containing 2 milligrams [mg]) two times a day (in the morning and evening) for the first 2 weeks. After 2 weeks, apply it once a day in the evening (before bedtime) for 4 weeks. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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