Uceris

Ulcerative Colitis

Uceris is primarily prescribed to treat mild to moderate active ulcerative colitis, a chronic inflammatory bowel disease that causes sores and inflammation in the lining of the colon and rectum. It is used to help get symptoms under control, a process known as inducing remission.

Forms and Specific Uses

The medication is available in different forms depending on the location of the inflammation and the specific needs of the patient:

• Oral Tablets: These extended-release tablets are used to treat active ulcerative colitis. They are also used in some cases to help maintain remission in adults.
• Rectal Foam: This form is specifically used to treat active mild to moderate ulcerative colitis that affects the distal (lower) parts of the colon, such as the rectum and the sigmoid colon.

Uceris is a localized corticosteroid. It is designed to release the medication directly in the areas of the gut where inflammation occurs, which may help limit the amount of medicine absorbed into the rest of the body compared to other types of steroids.

Mechanism of Action

Uceris contains budesonide, a medicine known as a corticosteroid. It works by decreasing the body's immune response and reducing inflammation, swelling, and redness in the digestive tract.

In conditions like ulcerative colitis, the immune system becomes overactive and attacks the lining of the colon. Uceris helps by:

• Blocking the release of substances in the body that cause inflammation.
• Reducing the activity of the immune system in the specific area where the medicine is applied or released.

Targeted Delivery

Uceris is designed to provide localized treatment, meaning it acts primarily on the site of inflammation rather than throughout the entire body. This is achieved through different delivery methods:

• Extended-release tablets: These use a specific technology to ensure the medicine is released slowly as it passes through the intestines, reaching the colon where it is needed most.
• Rectal foam: This formulation is applied directly to the lower part of the large intestine to treat inflammation in that specific area.

Because the medicine targets the gut and is quickly processed by the liver, less of it circulates in the bloodstream compared to some other types of steroid medications.

Common Side Effects

Some people may experience mild side effects while taking Uceris. Common symptoms include:

• Headache
• Nausea or stomach pain
• Indigestion or constipation
• Feeling tired or dizzy
• Acne
• Joint or back pain
• Cold symptoms, such as a sore throat or cough

Serious Side Effects

While less common, Uceris can cause serious side effects. Contact a doctor immediately if you notice:

• Signs of infection: Fever, chills, or body aches.
• Vision problems: Blurred vision, eye pain, or seeing halos.
• Mental health changes: New or worsening depression, anxiety, or mood swings.
• Physical changes: Swelling in the ankles or feet, or rapid weight gain.
• Skin issues: Thinning skin, easy bruising, or reddish-purple stretch marks.
• Signs of high cortisol: A rounded face (moon face) or a fatty hump between the shoulders.

Seek emergency medical care if you experience signs of a severe allergic reaction, including hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.

Infection Risk

Budesonide can lower the body's ability to fight infections. It is important to avoid contact with individuals who have contagious diseases, such as chickenpox or measles. If exposure occurs, a healthcare provider should be contacted immediately. People with active or inactive tuberculosis, or those with untreated fungal, bacterial, or viral infections, should use this medication with caution.

Adrenal and Hormonal Issues

Switching from a systemic corticosteroid (like prednisone) to Uceris may cause adrenal insufficiency, a condition where the body does not produce enough natural steroids. This can be dangerous during periods of physical stress, such as surgery or severe illness. Long-term use can also lead to hypercorticism (Cushing's syndrome), which may cause symptoms like weight gain, a rounded face, and thinning skin.

Long-Term Health Effects

• Bone Health: Extended use of corticosteroids can lead to a loss of bone mineral density, increasing the risk of osteoporosis and fractures.
• Eye Problems: This medication may increase the risk of developing cataracts or glaucoma. Regular eye exams may be necessary for those using the drug for long periods.
• Growth in Children: Corticosteroids can slow growth in children and adolescents.

Pre-existing Conditions

Certain medical conditions may require closer monitoring or affect how the drug is used, including:

• Liver disease (cirrhosis)
• High blood pressure
• Stomach ulcers
• Diabetes
• A history of tuberculosis

Dietary Precautions

Grapefruit and grapefruit juice should be avoided while taking Uceris, as they can increase the levels of the medication in the bloodstream and raise the risk of side effects.

Pregnancy

There are no adequate and well-controlled studies on the use of Uceris in pregnant women. In animal studies, corticosteroids like budesonide have been shown to cause fetal harm, including bone growth issues and cleft palate, when administered at high doses. While Uceris is designed to act locally in the digestive tract and has lower systemic absorption than some other steroids, the potential risk to a human fetus remains uncertain.

If you are pregnant or planning to become pregnant, consult your doctor to determine if the benefits of treating your condition outweigh the potential risks to the pregnancy. Infants born to mothers who used significant amounts of corticosteroids during pregnancy should be monitored for signs of adrenal insufficiency.

Breastfeeding

Budesonide, the active ingredient in Uceris, is known to pass into breast milk. Although the amount of medication an infant might receive through breastfeeding is expected to be low, the potential effects on a nursing child are not fully known. Healthcare providers generally recommend weighing the importance of the drug to the mother against the benefits of breastfeeding for the infant.

If you are breastfeeding or plan to breastfeed, talk to your healthcare provider about the safest way to manage your treatment while ensuring the health of your baby.

Available Forms

Uceris is provided in two primary delivery formats:

• Extended-release tablets: Taken by mouth, these tablets are formulated to provide a controlled release of the medication as it passes through the digestive tract.
• Rectal foam: This version is administered rectally and is supplied in a pressurized canister with disposable applicators.

FDA Approval and Indications

Uceris (budesonide) is approved by the U.S. Food and Drug Administration (FDA) for the induction of remission in patients with active, mild to moderate ulcerative colitis. The specific application depends on the dosage form:

• Oral Tablets: Approved for treating active, mild to moderate ulcerative colitis.
• Rectal Foam: Approved for treating active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

Regulatory Status

Uceris is a prescription-only medication. It is not classified as a controlled substance. There are no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) currently required by the FDA for this medication.

Usage Limitations

The FDA-approved labeling for Uceris focuses on the induction of remission. It is generally intended for short-term use (typically 8 weeks) rather than long-term maintenance of remission.

Factors Influencing Cost

The price of Uceris can fluctuate depending on several factors:

• Medication Form: Uceris is available as an extended-release oral tablet and as a rectal foam. The costs for these two delivery methods differ significantly.
• Generic Availability: Generic versions of budesonide extended-release tablets are available and are typically less expensive than the brand-name Uceris tablets. Generic availability for the rectal foam may be more limited.
• Insurance Coverage: Your out-of-pocket expenses depend on your insurance plan's formulary, deductible, and copayment levels. Some insurance providers may require prior authorization or step therapy before covering the brand-name version.
• Pharmacy Selection: Prices can vary between different retail pharmacies, and mail-order pharmacy services may offer different pricing structures for long-term supplies.

Financial Assistance and Savings

There are several options that may help reduce the cost of Uceris:

• Manufacturer Savings Cards: The manufacturer may offer coupons or savings cards for patients with commercial insurance to help lower copayments.
• Patient Assistance Programs: Programs may be available to provide the medication at a reduced cost or for free to individuals who meet specific financial eligibility criteria and lack insurance coverage.
• Generic Alternatives: Discussing the use of generic budesonide with a healthcare provider can often lead to lower out-of-pocket costs.