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Nov 17, 2023

Stelara (ustekinumab): Side effects, dosage, cost, and more

Stelara is a brand-name prescription medication. It’s approved by the Food and

Stelara is a brand-name prescription medication. It's approved by the Food and Drug Administration (FDA) to treat:

Stelara contains the drug ustekinumab. It's a monoclonal antibody, which is a type of drug that's made in a lab from immune system cells.

Stelara comes as a liquid solution that's typically given as a subcutaneous injection.

However, when Stelara is used to treat Crohn's disease or ulcerative colitis, your first dose is given as an intravenous (IV) infusion (an injection into your vein that's given over a period of time). Each dose after the IV infusion is given as a subcutaneous injection. Stelara subcutaneous injections may be self-injected or given by a healthcare professional.

In clinical studies, Stelara was effective in treating plaque psoriasis, psoriatic arthritis, and Crohn's disease. For more information on the drug's effectiveness, see the "Stelara uses" section directly below.

The Food and Drug Administration (FDA) approves prescription drugs such as Stelara to treat certain conditions. Stelara may also be used off-label for other conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.

Stelara is FDA-approved to treat moderate to severe plaque psoriasis in adults and children ages 6 years and older.

It's approved for use in people who could receive treatment with either:

Plaque psoriasis is an autoimmune disease that causes plaques on your skin. Plaques are areas on your skin that are raised and may be red- or silver-colored. They may also feel itchy.

In clinical studies, Stelara was effective in treating adults and adolescents with moderate to severe plaque psoriasis.

After 12 weeks of treatment:

Also, 77.3% of children ages 6 to 11 years had very few to no plaques on their skin. No one in this age group took a placebo.

These studies also looked at how many people had fewer plaques on their skin after treatment. The studies found that:

Additionally, just over 84% of children ages 6 to 11 years had at least a 75% improvement in their psoriasis symptoms. No one in this age group took a placebo.

Stelara is FDA-approved to treat psoriatic arthritis in adults. It's approved for use on its own or in combination with methotrexate.

Psoriatic arthritis is a condition that causes patches of psoriasis on your skin and arthritis in your joints.

In clinical studies, Stelara was effective in improving psoriatic arthritis symptoms in adults. After 6 months of treatment:

About half of the people in these studies were taking Stelara in combination with stable doses of methotrexate.

Stelara is FDA-approved to treat moderate to severe Crohn's disease in adults.

Crohn's disease is a type of inflammatory bowel disease. It causes inflammation in your gastrointestinal (GI) tract.

With Crohn's disease, you may have:

One clinical study looked at effectiveness after 8 weeks of treatment. In this study, clinical remission (having very few or no symptoms) was reached in 14% to 21% more people who took Stelara than in those who took a placebo (treatment with no active drug).

Clinical remission can also be defined based on a scoring system that measures how severe people's Crohn's disease symptoms are. Lower scores show fewer Crohn's disease symptoms. If you have a score of less than 150 points, you’re considered to be in remission. The highest possible score is 1,100.

In these 8-week studies, between 18% and 26% more people taking Stelara than those taking the placebo had a decreased score of at least 100 points.

Stelara is FDA-approved to treat moderate to severe ulcerative colitis in adults.

This condition is a type of inflammatory bowel disease. It causes inflammation in your gastrointestinal (GI) tract.

With ulcerative colitis, you may have:

In clinical studies, Stelara was effective in treating ulcerative colitis in adults. To learn how the drug performed in these studies, see Stelara's prescribing information.

Additionally, guidelines from the American Gastroenterological Association suggest Stelara as a treatment option for adults with moderate to severe ulcerative colitis.

In addition to the uses listed above, Stelara may be used off-label for other conditions. Off-label drug use is when a drug that's approved for one use is used for a different one that's not approved. And you may wonder if Stelara is used for certain other conditions.

Stelara for ankylosing spondylitis (off-label use)

Stelara isn't FDA-approved to treat ankylosing spondylitis (AS).

In clinical studies of Stelara, some people with psoriatic arthritis also had AS. In people with both conditions, Stelara decreased AS symptoms by at least half in 29.3% of people after 6 months of treatment. In people taking a placebo (treatment with no active drug), 11.4% of people had the same result.

However, more recent studies didn't find the drug to be effective in treating AS. These studies were stopped early because Stelara was no more effective than a placebo in reducing AS symptoms.

If you’re interested in using Stelara to treat AS, talk with your doctor.

Stelara for lupus (off-label use)

Stelara isn't FDA-approved to treat lupus.

In a small clinical study, Stelara was given to people with active systemic lupus erythematosus. After 6 months of treatment, 62% of people taking Stelara had significantly reduced symptoms. Of people taking a placebo (treatment with no active drug), 33% had the same results. Both groups of people received their treatment in combination with standard lupus medications.

However, a more recent study was stopped early because Stelara wasn't more effective than a placebo in reducing lupus symptoms.

If you’re interested in using Stelara to treat lupus, talk with your doctor.

Stelara for rheumatoid arthritis (not an appropriate use)

Stelara isn't FDA-approved to treat rheumatoid arthritis (RA). And it hasn't been shown effective for treating this condition.

In a clinical study, Stelara was given in combination with methotrexate to people with active RA. After 28 weeks of treatment, Stelara didn't improve people's RA symptoms any more than a placebo (treatment with no active drug) did.

If you’re interested in knowing more about treatment options for RA, talk with your doctor.

Stelara is FDA-approved for use in children ages 6 and older with moderate to severe plaque psoriasis. See the "Stelara for plaque psoriasis" section above for more details.

Stelara contains the active drug ustekinumab, which is a biologic. It's not currently available in biosimilar form. Stelara is available only as a brand-name medication.

A biosimilar medication is a medication that's similar to a brand-name biologic medication (the parent drug).

Biologics are made from living cells. It's not possible to make an exact copy of a biologic. A generic, on the other hand, refers to medications made from chemicals. A generic is an exact copy of the active medication in a brand-name medication.

Biosimilars are considered to be just as safe and effective as their parent drug. And like generics, biosimilars tend to cost less than brand-name medications.

Stelara can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Stelara. These lists do not include all possible side effects.

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

The more common side effects of Stelara can include:

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

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

Serious side effects and their symptoms can include the following:

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here's some detail on some of the side effects this drug may or may not cause.

As with most drugs, some people can have an allergic reaction after taking Stelara. These were rare in the drug's clinical studies, though.

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 a severe allergic reaction to Stelara. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

You may experience headaches while you’re using Stelara.

Headaches were one of the most common side effects reported during clinical trials. Of people taking Stelara for plaque psoriasis, 5% of people had a headache. Of people taking a placebo (treatment with no active drug), 3% had a headache.

Also, of people taking Stelara for ulcerative colitis, 10% of people had a headache. This was compared with 4% of people who took a placebo.

If you have headaches while you’re taking Stelara, talk with your doctor about using over-the-counter medications to help relieve your pain.

Fatigued (lack of energy) was a common side effect seen during clinical trials of Stelara.

Of people taking Stelara for plaque psoriasis, 3% of people had fatigue. Of people taking a placebo (treatment with no active drug), 2% had fatigue. Also, of people taking Stelara for ulcerative colitis, 4% had fatigue. This was compared with 2% of people who took a placebo.

If you feel fatigued during Stelara treatment, talk with your doctor about ways to increase your energy level.

Depression is a possible side effect of Stelara.

During clinical trials of people with plaque psoriasis, depression was reported in 1% of people taking Stelara. Depression was reported in less than 1% of people taking a placebo (treatment with no active drug). It's not known whether this side effect occurred in people taking Stelara for ulcerative colitis.

Also, people with autoimmune diseases, such as Crohn's disease or psoriasis, may have a higher risk of depression. It's thought that the stress of having a chronic (long-term) autoimmune disease can lead to depression in some people.

If you feel depressed while you’re taking Stelara, talk with your doctor about ways to help improve your mood.

It's not clear if Stelara causes joint pain.

In clinical studies, which included people with psoriatic arthritis, 3% of people taking Stelara had joint pain. Of those taking a placebo (treatment with no active drug), 1% had joint pain. However, joint pain is also a symptom of psoriatic arthritis.

Also, of people in studies taking Stelara for ulcerative colitis, 4.5% to 8.7% had joint pain. This was compared with 8.6% of people who took a placebo.

If you’re taking Stelara and are having joint pain, talk with your doctor about ways to help reduce your pain.

It's not known whether cancer is a side effect of Stelara. However, in clinical studies, new cases of cancer were reported during treatment with the drug.

In clinical studies of people with plaque psoriasis, 1.5% of those taking Stelara reported a nonmelanoma skin cancer. Also in these studies, 1.7% of people taking Stelara developed cancer other than nonmelanoma skin cancer. These types of cancer included prostate cancer, breast cancer, and colorectal cancer.

In clinical studies of people with Crohn's disease, 0.2% of those taking Stelara developed a nonmelanoma skin cancer. Of those taking a placebo (treatment with no active drug), 0.2% had the same result. Cancers other than nonmelanoma skin cancer were also reported in 0.2% of people taking Stelara. These types of cancer weren't reported in any of the people taking the placebo in the studies.

In studies of people with ulcerative colitis, 0.36% of people taking Stelara developed a nonmelanoma skin cancer. No one who took a placebo had this result. Additionally, 0.48% of people taking Stelara developed a cancer other than nonmelanoma skin cancer. This was compared with 0.31% of people who took a placebo.

It's not clear if Stelara causes cancer. However, Stelara does lower your immune system's ability to attack and destroy cancer cells. Because of this, you may have an increased risk of cancer with Stelara use. This risk could be greater for people ages 60 years and older, and for people who’ve taken drugs that lower their immune system's function for a long time.

While you’re taking Stelara, your doctor will monitor you closely for any signs of cancer, including skin cancer. If you’re concerned about your risk of developing cancer while using Stelara, talk with your doctor.

In clinical studies of people with plaque psoriasis, diarrhea occurred in 2% of those taking Stelara. And 2% of people taking a placebo (treatment with no active drug) had diarrhea.

In people with ulcerative colitis, 4% of people taking Stelara had diarrhea. This was compared with 1% of people who took a placebo.

However, this wasn't a commonly reported side effect in people taking Stelara for psoriatic arthritis or Crohn's disease.

If you have diarrhea while you’re using Stelara, talk with your doctor about ways to reduce this side effect.

You may have more frequent colds while you’re using Stelara.

In clinical studies of people with plaque psoriasis or Crohn's disease, 4% to 11% of people taking Stelara had upper respiratory infections. Of people taking a placebo (treatment with no active drug), 5% to 8% had upper respiratory infections.

In people with ulcerative colitis, 24% of people taking Stelara had upper respiratory infections. This was compared with 20% of people who took a placebo.

These upper respiratory infections included runny nose or the common cold. Colds and runny nose may occur because Stelara decreases your immune system's ability to fight off infections.

If you have frequent colds while you’re using Stelara, talk with your doctor about ways to treat your symptoms.

Weight gain or weight loss (not a side effect)

In clinical studies, weight gain and weight loss weren't reported as side effects of Stelara.

However, weight loss can be a symptom of Crohn's disease or ulcerative colitis. Keep in mind, Stelara can be used to treat these conditions.

If you’re gaining or losing weight during Stelara treatment, talk with your doctor. They’ll help identify any possible health reasons for your weight change.

Hair loss (not a side effect)

Hair loss was not a side effect of Stelara in clinical studies. However, hair loss could be a symptom of plaque psoriasis, which Stelara is used to treat.

Additionally, hair loss can be a side effect of methotrexate. This drug may be used in combination with Stelara to treat psoriatic arthritis.

If you have hair loss during Stelara treatment, talk with your doctor. They’ll check to see if you have other health conditions that may be causing your hair loss. They can also discuss ways to help reduce your hair loss.

Eczema (not a side effect)

Eczema is not a side effect of Stelara treatment.

However, in clinical studies of people with plaque psoriasis and Crohn's disease, itchy skin was reported in up to 4% of people using Stelara and up to 2% of those taking a placebo (treatment with no active drug).

If you develop eczema or have itchy skin while you’re using Stelara, talk with your doctor about ways to manage your symptoms.

In a clinical study, children ages 12 years and older with plaque psoriasis used Stelara for treatment. The side effects in these children were similar to the side effects in adults with plaque psoriasis during other clinical studies.

The Stelara dosage your doctor prescribes will depend on several factors. These include:

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

Stelara comes as a liquid solution that contains the active drug ustekinumab.

It's available as:

Stelara is given as a subcutaneous injection. It can be given in your upper arms, thighs, belly, or buttocks.

Your healthcare professional may give you Stelara injections at a medical clinic. They may also show you how to self-inject Stelara at home.

Note: Stelara also comes in a vial that contains 130 mg of ustekinumab. This vial is used for a one-time intravenous (IV) infusion (an injection into your vein that's given over a period of time) of Stelara. It's used to give the first dose of the drug to people with Crohn's disease or ulcerative colitis. This one-time infusion is called a "loading dose" or an "induction dose." This IV infusion will take place over at least 1 hour. Each dose of Stelara after the IV infusion is given as a subcutaneous injection.

Stelara is approved to treat plaque psoriasis in both adults and children ages 6 years and older. The typical dosage for adults is described here.

Stelara is given as one subcutaneous injection on each of the following days:

The usual dosage of Stelara for plaque psoriasis is based on your body weight and age. In adults with plaque psoriasis, the typical dosage of Stelara for each injection is as follows:

The usual dose of Stelara for adults with psoriatic arthritis is 45 mg for each injection.

Stelara is given as one subcutaneous injection on each of the following days:

If you have psoriatic arthritis with plaque psoriasis, your doctor may prescribe a higher dosage of Stelara for you.

The usual dosage of Stelara for adults with Crohn's disease is 90 mg given once every 8 weeks. Stelara is given as a subcutaneous injection. When treating Crohn's disease, this is called your maintenance dose.

However, the first dose of Stelara that you’ll receive is called an induction (loading) dose. It's given as an intravenous (IV) infusion (an injection into your vein that's given over a period of time). This infusion lasts at least 1 hour.

The usual dosage for the loading dose is based on your body weight, as follows:

Every dose of Stelara that you receive after your loading dose will be given as a subcutaneous injection.

The usual dosage of Stelara for adults with ulcerative colitis is 90 mg given once every 8 weeks. Stelara is given as a subcutaneous injection. When treating ulcerative colitis, this is called your maintenance dose.

However, the first dose of Stelara that you’ll receive is called an induction (loading) dose. It's given as an intravenous (IV) infusion (an injection into your vein that's given over a period of time). This infusion lasts at least 1 hour.

The usual dosage for the loading dose is based on your body weight, as follows:

Every dose of Stelara that you receive after your loading dose will be given as a subcutaneous injection.

Stelara is approved to treat plaque psoriasis in both adults and children ages 6 years and older. The typical dosage for children is described below.

Stelara is given as one subcutaneous injection on each of the following days:

The dosage of Stelara for plaque psoriasis is based on body weight and age. In children with plaque psoriasis, the typical dosage of Stelara for each injection is as follows:

For example, a child who weighs 88 pounds (about 40 kilograms) will receive a 30-mg dose of Stelara. This is calculated by multiplying 40 kilograms by 0.75 milligrams of drug, which equals 30 mg of drug.

It's important to keep your appointments with your healthcare professional for Stelara injections. If you miss an appointment, call your doctor's office right away. They can reschedule your appointment.

If you’re using Stelara at home and you miss a dose, take it as soon as you remember. Don't take more than one dose at a time. This can increase your risk of serious side effects.

Talk with your doctor about any missed doses. They can help you set up a new schedule for your Stelara treatment.

To help make sure that you don't miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Stelara is meant to be used as a long-term treatment. If you and your doctor determine that Stelara is safe and effective for you, you’ll likely take it long term.

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

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

Janssen Biotech, Inc., the manufacturer of Stelara, offers a program called Janssen CarePath. For more information and to find out if you’re eligible for support, call 877-CAREPATH (877-227-3728) or visit the program website.

Stelara may be used with other drugs to treat:

Your doctor will recommend if you need to take other drugs with Stelara to treat your condition.

When it's used to treat psoriatic arthritis, Stelara is FDA-approved for use alone or in combination with methotrexate (Otrexup, Trexall). Your doctor will discuss with you whether the combination of Stelara and methotrexate is right for you.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Stelara, 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 used off-label to treat these specific conditions.

Examples of other drugs that may be used to treat plaque psoriasis include:

Examples of other drugs that may be used to treat psoriatic arthritis include:

Examples of other drugs that may be used to treat Crohn's disease include:

Examples of other drugs that may be used to treat ulcerative colitis include:

You may wonder how Stelara compares to other medications that are prescribed for similar uses. Here we look at how Stelara and Humira are alike and different.

Stelara contains the drug ustekinumab, while Humira contains the drug adalimumab. They’re both monoclonal antibodies, which are drugs that are made from immune system cells.

Stelara and Humira are both FDA-approved to treat:

Stelara is also approved to treat moderate to severe plaque psoriasis in children ages 6 years and older.

Humira is also approved to treat Crohn's disease in children ages 6 years and older. And it's approved to treat ulcerative colitis in children ages 5 years and older.

Additionally, Humira is also approved to treat:

Stelara and Humira both come as a liquid solution that's given as a subcutaneous injection.

For people taking Stelara to treat Crohn's disease or ulcerative colitis, their first dose is given by intravenous (IV) infusion (an injection into your vein that's given over a period of time). The infusion lasts for at least 1 hour. The rest of their doses are given by subcutaneous injection.

Stelara and Humira can both be given as injections at your doctor's office or clinic. They can also be self-injected at home, after your healthcare professional has shown you how to inject the drugs.

Stelara can be injected under the skin of your upper arms, thighs, belly, or buttocks. Humira can be injected under the skin of your thighs or belly.

Stelara comes as a disposable prefilled syringe that's meant to be used once. It also comes as a single-dose vial that you’ll inject using a syringe and needle. Stelara also comes in a single-use vial that's used for injections given by healthcare professionals.

Humira comes as prefilled, single-dose pens and syringes. It also comes in a single-use vial that's used for injections given by healthcare professionals.

Stelara and Humira both contain different drugs. Therefore, the medications can cause very different side effects. Below are examples of these side effects.

These lists contain examples of more common side effects that can occur with Stelara, with Humira, or with both drugs (when taken individually).

These lists contain examples of serious side effects that can occur with Stelara, with Humira, or with both drugs (when taken individually).

Stelara and Humira have different FDA-approved uses. But they’re both used to treat psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis.

The effectiveness of these drugs in treating plaque psoriasis has been compared in studies. An analysis that pooled the results of several studies found that Stelara and Humira may have similar effectiveness in treating adults with plaque psoriasis. Another analysis found that these drugs may have similar effectiveness in treating children with plaque psoriasis.

The effectiveness of Stelara and Humira in treating psoriatic arthritis has also been compared in an analysis. This analysis found that Humira may be more effective than Stelara in treating psoriatic arthritis.

Stelara and Humira are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

However, there are biosimilar products of Humira available. Biosimilar drugs are similar versions of the original brand-name drug that are approved to treat some of the same conditions as the original drug. They may cost less than the original drug.

Humira may cost less than Stelara. The actual price you’ll pay for either drug depends on your dosage, your insurance plan, your location, and the pharmacy you use.

You may wonder how Stelara compares to other medications that are prescribed for similar uses. Here we look at how Stelara and Cosentyx are alike and different.

Stelara contains the drug ustekinumab. Cosentyx contains the drug secukinumab. They’re both monoclonal antibodies, which are drugs that are made from immune system cells.

Stelara and Cosentyx are both FDA-approved to treat:

Stelara is also approved for use in adults to treat moderate to severe:

And Cosentyx is also approved for use in adults to treat:

Stelara and Cosentyx both come as a liquid solution that's given as a subcutaneous injection.

For people taking Stelara to treat Crohn's disease or ulcerative colitis, their first dose is given by intravenous (IV) infusion (an injection into your vein that's given over a period of time). The infusion lasts for at least 1 hour. The rest of their doses are given by subcutaneous injection.

Stelara and Cosentyx can both be given as injections at your doctor's office. They can also be self-injected at home, after your healthcare professional has shown you how to inject them.

Stelara and Cosentyx can be injected under the skin of your upper arms, thighs, or belly. Stelara can also be injected into your buttocks.

Stelara comes as a disposable, prefilled syringe that's meant to be used once. It also comes as a single-dose vial that you’ll inject using a syringe and needle. As well, Stelara comes in a single-use vial that's used for injections given by healthcare professionals.

Cosentyx comes as a disposable, prefilled syringe that's meant to be used once. It also comes as a single-dose pen (called the Sensoready pen). As well, Cosentyx comes in a single-use vial that's used for injections given by healthcare professionals.

Stelara and Cosentyx contain different drugs. Therefore, they can cause different side effects. Below are examples of these side effects.

These lists contain examples of more common side effects that can occur with Stelara, with Cosentyx, or with both drugs (when taken individually).

These lists contain examples of serious side effects that can occur with Stelara, with Cosentyx, or with both drugs (when taken individually).

Stelara and Cosentyx have different FDA-approved uses, but they’re both used to treat plaque psoriasis and psoriatic arthritis.

Stelara and Cosentyx have been compared in studies as treatments for these conditions.

An analysis that pooled the results of several studies found that Stelara and Cosentyx may have similar effectiveness in treating plaque psoriasis in adults. A different analysis found that Stelara and Cosentyx were similarly effective in treating psoriatic arthritis.

Stelara and Cosentyx are both brand-name drugs. There are currently no biosimilar forms of either drug. Biosimilar drugs are similar versions of the original brand-name drug that are approved to treat some of the same conditions as the original drug. They may cost less than the original drug.

The actual price you’ll pay for either drug depends on your dosage, your insurance plan, your location, and the pharmacy you use.

There aren't any known interactions between Stelara and alcohol. Talk with your doctor about whether it's safe for you to drink alcohol while you’re using Stelara.

Stelara can interact with several other medications and therapies.

Different drug interactions can cause different effects in your body. For instance, some interactions can interfere with how well a drug works for you. Other interactions can increase a drug's side effects or make them more severe.

Below are lists of medications and therapies that can interact with Stelara. These lists do not contain all the drugs that may interact with Stelara.

Before taking Stelara, 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.

You shouldn't get a live vaccine when you’re using Stelara. Getting a live vaccine during Stelara treatment increases your risk of getting the condition the vaccine is meant to prevent.

This is because Stelara suppresses (lowers) your immune system's ability to fight infections. Receiving a live vaccine during Stelara treatment increases your risk of serious infections.

Examples of live vaccines that you should avoid during Stelara treatment include:

You should also avoid getting the Bacillus Calmette-Guérin (BCG) vaccine for 1 year before you start using Stelara, during your Stelara treatment, and for 1 year after you stop using Stelara. The BCG vaccine is meant to prevent tuberculosis (TB). It's more commonly given to people who live outside of the United States.

If you’re using Stelara, it also might not be safe for you if people in your household get a live vaccine. This is because they may be able to pass to you the virus that was contained in the live vaccine.

If you get a non-live vaccine during Stelara treatment, your immune system might not be strong enough to protect you from the condition that the vaccine is used for. Talk with your doctor about whether it's safe for you to get a non-live vaccine while you’re using Stelara.

It's not known if it's safe to get allergy shots (called immunotherapy) while you’re using Stelara. This is because Stelara may affect how your immune system responds to the allergy shots.

Getting allergy shots while you’re using Stelara may cause the shots to not work as well for you. You may also have an increased risk of having a serious allergic reaction (including anaphylaxis) to the allergy shots.

If you receive allergy shots, be sure to tell your doctor if you’re also using Stelara. They’ll discuss with you the risks and benefits of treatment. They’ll also monitor you more closely for serious reactions to your allergy shots.

Taking Stelara with warfarin (Jantoven) can change the level of warfarin in your body. This can affect how well warfarin works for you. It could also increase your risk of side effects, such as bleeding.

If you need to take warfarin while you’re using Stelara, your doctor may closely monitor certain lab tests to check the ability of your blood to form clots. Your doctor will also monitor you closely for side effects, such as bleeding.

If you’re taking these drugs together, your doctor may need to adjust your dosage of either Stelara or warfarin.

Taking Stelara with certain drugs used during and after organ transplants can change the level of the transplant drug in your body. This can affect how well the drugs work for you, or even increase your risk of serious side effects.

Examples of transplant drugs that may be affected by Stelara include:

If you need to take one of these transplant drugs with Stelara, your doctor will order lab tests to monitor your levels of the transplant drug. They’ll also monitor you more closely for side effects. Your doctor may adjust your dosage of either Stelara or the transplant drug if you’re taking these medications together.

There haven't been enough studies in pregnant people to know whether Stelara is safe to use during pregnancy.

Studies in animals didn't show harm to the fetus when pregnant animals were given Stelara. However, animal studies don't always predict what will happen in humans.

If you’re pregnant or planning to become pregnant, talk with your doctor about safe treatment options for your condition.

It's not known if Stelara is safe to use during pregnancy. Talk with your doctor about your birth control needs while you’re using Stelara.

It's not known if Stelara is safe to use while you’re breastfeeding.

In animal studies, Stelara did pass into breast milk when it was given to lactating females. However, there isn't enough information to know if Stelara passes into human breast milk.

If you’re considering using Stelara while breastfeeding, talk with your doctor about whether this is safe for your child.

You should use Stelara according to your doctor or healthcare professional's instructions.

Stelara is given as a subcutaneous injection. Your healthcare professional will give you your first dose. They may also show you how to self-inject the drug at home for your future doses.

If you are taking Stelara to treat Crohn's disease or ulcerative colitis, your first dose will be given as an intravenous (IV) infusion (an injection into your vein that's given over a period of time). This infusion usually lasts at least 1 hour. You’ll get the infusion in a healthcare office or clinic. The rest of your doses will be given as subcutaneous injections, which can be given by either your healthcare professional or yourself.

The manufacturer of Stelara provides step-by-step instructions for self-injections. They also provide instructional videos that review how to use Stelara.

Stelara can be used at any time of the day. It doesn't matter what time you choose to use the medication.

It's important to go to all of your scheduled appointments if you’re receiving Stelara from a healthcare professional. If you are self-injecting the drug at home, make sure to keep track on a calendar when your injections are needed.

To help make sure that you don't miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Stelara is a biologic medication. This means it's a drug that's made in a lab from living things (such as plant or animal cells). Stelara is also called a monoclonal antibody. These drugs are proteins made from immune system cells.

Stelara is approved to treat:

These conditions are partly caused by an overactive immune system. With an overactive immune system, your body mistakes normal cells for foreign invader cells, such as germs. This causes symptoms of the conditions, including skin plaques, joint pain, or inflammation in your intestines.

Stelara helps decrease your immune system's activity by attaching to specific proteins, called interleukin-12 (IL-12) and interleukin-23 (IL-23). These proteins cause inflammation in your body. They also turn on other immune system cells, which leads to worsening symptoms of your condition.

When Stelara attaches to IL-12 and IL-23, it blocks them from causing inflammation and from turning on other immune system cells. This results in less inflammation, fewer symptoms, and improvement in your condition.

Stelara starts working inside your body shortly after you take a dose. However, it could be several weeks before you start to notice that your symptoms have eased.

Here are answers to some frequently asked questions about Stelara.

It's possible that your condition may return or worsen if you stop taking Stelara. This can lead to symptoms that may be confused with withdrawal symptoms.

Don't stop taking Stelara unless your doctor recommends that you stop treatment. Once you stop taking Stelara, your doctor will monitor you closely to determine if you can safely remain off the medication.

Stelara makes your immune system (your body's defense against disease) less able to function. Certain vaccines (called live vaccines) are made from weakened forms of a virus. Because your immune system can't fight off the virus very well, you shouldn't get live vaccines during Stelara treatment. Doing so can put you at risk for developing the infection that the vaccine is meant to prevent.

Your doctor may recommend that you have all of the vaccines you need before you start Stelara treatment. This includes both live and non-live vaccines, with the exception of the Bacillus Calmette-Guérin (BCG) vaccine.

The BCG vaccine is meant to prevent tuberculosis (TB). It's more commonly given to people who live outside of the United States. You shouldn't start taking Stelara for at least 1 year after you’ve received a BCG vaccine.

If you receive any non-live vaccines while you’re taking Stelara, it's possible that your immune system won't have the right response to the vaccine. This means that the vaccine might not be able to prevent the infection that it's meant to prevent.

Talk with your doctor to make sure you are up to date on all of your vaccinations before you start using Stelara.

No, Stelara doesn't have a black box warning, which is also called a boxed warning. These warnings are used to alert healthcare professionals and patients about very serious side effects that can happen with some drugs.

Stelara can cause serious side effects. But the Food and Drug Administration (FDA) hasn't required the manufacturers of Stelara to include a black box warning with this medication.

Yes. Stelara reduces your immune system's ability to fight off infections.

Stelara is used to treat conditions that are partly caused by an overactive immune system. These conditions include plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Having an overactive immune system can lead to inflammation, pain, and other health problems.

Stelara helps decrease the activity of your immune system, which helps stop it from attacking your joints and organs. This can improve your symptoms and your quality of life.

However, when your immune system activity is decreased, you have a greater risk of developing serious or rare infections. You may also have a greater risk of reactivation (flare-up) of infections, such as tuberculosis (TB), that you’ve had in the past. Reduced immune system function caused by Stelara may also increase your risk of certain cancers, including skin cancer.

Talk with your doctor about infections that you’ve had in the past. Also, you should call your doctor right away if you think you have an infection during Stelara treatment. If you develop an infection while you’re using Stelara, your doctor may have you stop using Stelara for a while. They’ll also inform you when it's safe for you to restart treatment.

Yes, you might need to continue using a topical cream with Stelara if the drug doesn't clear up your plaque psoriasis enough. Your doctor may prescribe topical creams for you to use with Stelara.

Before taking Stelara, talk with your doctor about your health history. Stelara may not be right for you if you have certain medical conditions. These include:

Note: For more information about the potential negative effects of Stelara, see the "Stelara side effects" section above.

Do not use more Stelara than your doctor recommends.

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

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

The expiration date helps guarantee the effectiveness of the medication 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, talk with your pharmacist about whether you might still be able to use it.

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

Stelara should be stored in the refrigerator at a temperature of 36°F to 46°F (2°C to 8°C). It should also be stored in its original carton until you’re ready to use the drug. This will protect it from direct light. Don't freeze or shake vials or syringes of Stelara.

If you no longer need to take Stelara 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.

The manufacturer of Stelara has a program called Safe Returns, which provides sharps disposal containers to you free of charge. You can even send your used sharps containers back to the program by using prepaid return packages. To find out more about this program, visit the manufacturer's website or call 877-227-3728.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Stelara (ustekinumab) is indicated for the treatment of:

Stelara is a monoclonal antibody, which binds to the p40 protein subunit used by both interleukin-12 (IL-12) and interleukin-23 (IL-23). IL-12 and IL-23 are cytokines involved in inflammation and immune system cell activation. Binding to IL-12 and IL-23 disrupts the inflammation cascade and reduces inflammation-related symptoms.

After subcutaneous injection, maximum concentration is reached in 7 days for the 90-mg dose, and in 13.5 days for the 45-mg dose. Steady-state concentration is reached by week 28.

Mean half-life ranges from 14.9 to 45.6 days. Metabolism occurs via catabolic degradation to small peptides and amino acids.

Stelara is contraindicated in patients with a history of severe hypersensitivity reaction to ustekinumab or any of Stelara's excipients.

Store Stelara vials and prefilled syringes in the refrigerator at a temperature of 36°F to 46°F (2°C to 8°C). Stelara vials should be kept upright in the refrigerator. Protect the product from light by keeping it in the original container until time of use. Do not freeze or shake Stelara vials or syringes.

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.