Uceris: Side effects, dosage, alternatives, and more (original) (raw)

Uceris is a brand-name drug that’s prescribed for ulcerative colitis. The medication is available in the following forms: rectal foam and oral tablet. Uceris belongs to the corticosteroid drug class.

Uceris is FDA-approved to induce remission* for mild to moderate ulcerative colitis (UC) in adults. It’s typically a short-term treatment.

Specifically, Uceris rectal foam is approved to treat UC that affects a certain area of the distal colon (the last part of the colon that connects to the rectum).

* With UC, to induce remission means to make your symptoms ease or go away.

Effectiveness

For information about the effectiveness of Uceris, see the “Uceris uses” section below.

Uceris is a brand-name drug that contains the active drug budesonide. This active drug is also available as a generic medication. A generic drug is an exact copy of the active drug in a brand-name medication.

The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

If you’re interested in trying the generic form of Uceris, talk with your doctor. They can tell you whether it comes in forms and strengths that can be prescribed for your condition.

Uceris can cause mild or serious side effects. The following lists contain some of the key side effects that may occur during treatment with Uceris. These lists do not include all possible side effects.

For more information about the possible side effects of Uceris, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Uceris, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Uceris. To learn about other mild side effects, talk with your doctor or pharmacist, or view the prescribing information for Uceris rectal foam or Uceris oral tablet.

Mild side effects of Uceris rectal foam can include:

Mild side effects of Uceris oral tablet can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Uceris, see “Allergic reaction” below.

Serious side effects

Serious side effects from Uceris aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* For details about allergic reaction and Uceris, see “Allergic reaction” below.

**ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction to Uceris. This side effect wasn’t reported in clinical trials of Uceris rectal foam or Uceris oral tablet, but has occurred since the drug was approved.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

Call your doctor right away if you have an allergic reaction to Uceris, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Your dosage of Uceris dosage will depend on the form of Uceris your doctor prescribes.

The following information describes dosages that are commonly prescribed or recommended. However, be sure to follow the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Uceris comes in the following forms and strengths:

* Extended release means the drug is slowly released into your body over a period of time.

Dosage for ulcerative colitis

The recommended dosage of Uceris oral tablets for ulcerative colitis (UC) is 9 mg taken once per day for up to 8 weeks.

The recommended dose of Uceris rectal foam for UC is 2 mg. You’ll administer this dose rectally twice per day for the first 2 weeks of treatment. Then you’ll administer 2 mg rectally once per day for the next 4 weeks.

What if I miss a dose?

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or putting a note where you’ll see it, such as on your bathroom mirror or bedside table. You could also download a reminder app on your phone.

Will I need treatment with this drug long term?

Uceris is meant to be a short-term treatment. You’ll likely take or administer it for 6 or 8 weeks, depending on the form of the drug your doctor prescribes.

Other drugs are available that can treat ulcerative colitis (UC). Some may be a better fit for you than others. If you’re interested in finding an alternative to Uceris, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are prescribed off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Alternatives for UC

Examples of other drugs that may be prescribed to treat mild to moderate UC include:

As with all medications, the cost of Uceris can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Uceris. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.

Before approving coverage for Uceris, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Uceris, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Uceris, or if you need help understanding your insurance coverage, help is available.

A program called the Instant Savings Program is available for Uceris rectal foam. For more information and to find out whether you’re eligible for support, call 855-558-1669 or visit the drug website.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Uceris may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Uceris, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Uceris is available in a generic form called budesonide. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs. To find out how the cost of budesonide compares with the cost of Uceris, talk with your doctor or pharmacist.

If your doctor has prescribed Uceris and you’re interested in trying budesonide instead, talk with your doctor. They may have a preference for one version or the other. You’ll also need to check your insurance plan, as it may only cover one or the other.

The Food and Drug Administration (FDA) approves prescription drugs such as Uceris to treat certain conditions. Uceris may also be prescribed off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Uceris for ulcerative colitis

Uceris oral tablet is FDA-approved to induce remission for mild to moderate ulcerative colitis (UC) in adults.

Uceris rectal foam is FDA-approved to induce remission for mild to moderate distal UC in adults. This is UC that affects a specific area of the distal colon (the last part of the colon that connects to the rectum).

During a flare, symptoms of UC are occurring. Uceris is prescribed to induce remission (make the symptoms stop or become less bothersome). Remission refers to a period of time when you have few to no symptoms.

Uceris is typically prescribed as a short-term treatment.

UC explained

UC is an inflammatory bowel disease that affects the colon. The condition involves periods of flares (times when symptoms are occurring).

Symptoms of UC may include:

You can learn more about this condition by visiting our inflammatory bowel disease hub.

Effectiveness for UC

Uceris has been found to be effective in treating UC. Budesonide, the active drug in Uceris rectal foam and Uceris oral tablet, is recommended as a treatment option by the American Gastroenterological Association (AGA). The drug is included in the AGA’s treatment guidelines for mild to moderate UC.

For information on how the drug performed in clinical trials, see the prescribing information for Uceris rectal foam and Uceris oral tablet.

Uceris and children

It isn’t known whether Uceris is safe for use in children. The drug is only approved for UC in adults.

Here are answers to some frequently asked questions about Uceris.

Is Uceris similar to prednisone?

Yes, in some ways. Uceris and prednisone both belong to the same drug class, called corticosteroids. They work in a similar way to reduce inflammation (swelling) in the body.

Uceris and prednisone are both available as an oral tablet. Uceris is also available as a rectal foam.

Uceris is a treatment that’s specifically prescribed for ulcerative colitis (UC). In contrast, prednisone is prescribed for a wide variety of conditions that cause inflammation anywhere in the body. For example, prednisone may be prescribed to treat airway inflammation (such as asthma) or skin inflammation (such as poison ivy). In some cases, doctors may prescribe prednisone short term to manage UC symptoms during flares.

If you have questions about Uceris and prednisone, talk with your doctor or pharmacist.

Does Uceris cause long-term side effects?

Uceris shouldn’t cause long-term side effects. This is because Uceris is a short-term treatment that you’ll likely take or administer for 6 or 8 weeks.

As with other corticosteroid drugs, taking or administering Uceris for a long time can raise the risk of certain side effects. Examples include increased blood pressure, high blood sugar, and hypercorticism (having too much cortisol in your blood).

Symptoms of hypercorticism may include:

Talk with your doctor if you have questions about your risk of long-term side effects with Uceris.

Is Uceris safe for older adults?

Yes, since Uceris is a short-term treatment prescribed to induce remission, it’s safe for most older adults. (Older adults typically refers to people ages 65 years and older.) However, experts do not recommend long-term maintenance use of corticosteroid drugs for UC in older adults.

In general, older adults may be more vulnerable to drug side effects. For example, Uceris weakens the immune system. This increases the risk of infection, such as pneumonia or shingles. And older adults may already have a weakened immune system due to older age or other medical conditions.

If you’re an older adult, your doctor will monitor you closely during Uceris treatment. Tell your doctor right away if you have symptoms of a possible infection, such as a fever.

If you have questions about Uceris for older adults, talk with your doctor.

Uceris is a corticosteroid drug. It’s prescribed to induce remission (make symptoms ease or stop) for ulcerative colitis (UC) in adults. It works by decreasing inflammation (swelling) in the intestines.

Uceris oral tablet is meant to treat mild to moderate UC. Uceris rectal foam is specifically prescribed to treat mild to moderate distal UC. Distal UC affects a specific area of the distal colon (the last part of the colon that connects to the rectum). Since Uceris foam is applied rectally, the foam doesn’t reach the entire colon.

Your doctor can help determine which form of Uceris is right for your condition.

How long does it take to work?

Uceris starts working soon after your first dose. In clinical trials, Uceris rectal foam typically worked within 6 weeks to induce UC remission (stop or reduce symptoms of UC). And Uceris oral tablet worked within 8 weeks to induce remission in clinical trials.

Talk with your doctor if you have questions about what to expect from Uceris treatment.

There are no known interactions between Uceris and alcohol.

However, consuming alcohol may worsen symptoms of ulcerative colitis (UC). Since Uceris is prescribed to treat UC, it may be best to avoid alcohol during treatment with the drug.

If you have questions about drinking alcohol during Uceris treatment, talk with your doctor or pharmacist.

Uceris can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe. Drug-condition interactions can also cause certain effects. For information about these interactions, see the “Uceris precautions” section below.

Uceris and other medications

Below is a list of medications that can interact with Uceris. This list does not contain all drugs that may interact with Uceris.

Certain drugs that increase the level of Uceris. CYP3A4 is an enzyme that breaks down certain drugs in the body. (Enzymes are proteins that speed up processes in your body.) Some drugs can inhibit (block or slow) this enzyme, causing drug interactions.

Taking these drugs with Uceris may increase the level of the drug in your body. This can increase the risk or severity of the drug’s side effects. Examples include:

Drugs that reduce stomach acid (Uceris oral tablet only). Uceris oral tablet is a coated tablet that you’ll swallow whole. Adequate stomach acid is required to dissolve the coating and release the active ingredient (budesonide). If you don’t have enough acid in your stomach, Uceris oral tablet may not work as well to treat your ulcerative colitis (UC).

Certain types of medications reduce the amount of acid in your stomach, so they can make Uceris less effective. These include:

Before starting Uceris, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Uceris and herbs and supplements

It’s important to note that the herb St. John’s wort can interact with Uceris. This is because St. John’s wort may lower the level of the drug in your body, which may make it less effective.

To help avoid interactions, check with your doctor or pharmacist before using any herbs or supplements during Uceris treatment.

Uceris and foods

It’s important to note that you should avoid eating grapefruit or drinking grapefruit juice during Uceris treatment. Consuming grapefruit with Uceris may increase the level of the drug in your body. This can increase the risk or severity of the drug’s side effects.

If you have questions about eating certain foods during treatment for UC, talk with your doctor.

Your doctor will likely recommend that you don’t take or administer Uceris while you’re pregnant.

Based on animal trials, Uceris rectal foam or Uceris oral tablet may cause fetal harm. But it’s important to note that animal trials don’t always predict what happens with humans.

There are also reports of preterm delivery and low birth weight of infants born to mothers who received budesonide (the active drug in Uceris) during pregnancy.

If you’re planning a pregnancy or can become pregnant, talk with your doctor about ulcerative colitis treatment options during pregnancy.

Uceris may not be safe to take or administer during pregnancy. If you or your partner can become pregnant, talk with your doctor about your birth control needs during treatment with Uceris.

For more information about Uceris treatment during pregnancy, see the “Uceris and pregnancy” section above.

It’s not known whether Uceris should be taken or administered while breastfeeding. No clinical trials have looked at the drug’s possible effects on breast milk or children who are breastfed.

If you’re currently breastfeeding or planning to do so, talk with your doctor about your options during this time. They may recommend other healthy ways to feed your child.

You should take or administer Uceris according to the instructions your doctor gives you.

Uceris oral tablet is taken by mouth.

Uceris rectal foam is applied by inserting the drug into the rectum. It comes as a canister with single-use applicators. Each applicator delivers one dose. The applicators come already coated in lubricant, but you can use petrolatum (Vaseline) if you’d prefer extra lubrication.

Uceris rectal foam comes with a detailed instruction guide. There’s also a video on how to administer Uceris rectal foam on the manufacturer’s website.

When to take

When you’ll take or administer Uceris depends on the form of the drug your doctor prescribes.

Uceris oral tablet should be taken in the morning. You’ll swallow the tablet whole with water.

With Uceris rectal foam, you’ll use one applicator in the morning and evening for the first 2 weeks of treatment. Then you’ll use one applicator in the evening for the next 4 weeks.

If possible, it’s best to have a bowel movement before you insert your dose. Moving your bowels after you insert your dose will cause some of the drug to be lost. This can make Uceris rectal foam less effective.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Accessible labels and containers

If your prescription label is hard to read, talk with your doctor or pharmacist. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist may be able to direct you to one that does.

If you have trouble opening medication bottles, ask your pharmacist if they can put Uceris in an easy-open container. They also may be able to recommend tools that can make it simpler to open lids.

Taking Uceris tablets with food

Uceris oral tablet can be taken with or without food.

Can Uceris tablets be crushed, split, or chewed?

No, you should not crush, split, or chew Uceris tablets. You’ll swallow the tablet whole.

This drug comes with several precautions. These are considered drug-condition interactions.

Before starting Uceris, talk with your doctor about your health history. Uceris may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

Note: For more information about the potential negative effects of Uceris, see the “Uceris side effects” section above.

Do not take or administer more Uceris than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take or administer too much Uceris

If you think you’ve taken or administered too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Uceris from the pharmacy, the pharmacist will add an expiration date to the label on the container. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, ask your pharmacist how to correctly dispose of it.

Storage

How long a medication remains good to use can depend on many factors, including how and where you store the medication.

Uceris tablets and Uceris rectal foam should be stored at a room temperature of 68°F to 77°F (20°C to 25°C) in a tightly sealed container away from light. You can temporarily store Uceris at temperatures between 59°F to 86°F (15°C to 30°C), such as when traveling. Avoid storing Uceris in areas where it could get damp or wet, such as bathrooms.

Uceris rectal foam should be kept away from open flames. It contains flammable ingredients.

Disposal

If you no longer need to take or administer Uceris and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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