ustekinumab
Stelara (ustekinumab) is an injectable medication used to treat autoimmune conditions like plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. As an interleukin antagonist, it works by blocking certain proteins that cause inflammation in your body, which helps reduce swelling and ease symptoms. You typically get it as an injection under your skin. Common side effects include common cold symptoms, headache, and feeling tired. This medication also has many biosimilars available.
What is Stelara (ustekinumab)?
What is Stelara (ustekinumab) used for?
- Moderate-to-severe plaque psoriasis (Ps) - adults and children 6 years and older
- Psoriatic arthritis (PsA) - adults and children 6 years and older
- Moderate-to-severe Crohn's disease (CD) - adults only
- Moderate-to-severe ulcerative colitis (UC) - adults only
How Stelara (ustekinumab) works
Stelara (ustekinumab) is an interleukin antagonist. It works by blocking two proteins in your immune system — interleukin-12 (IL-12) and interleukin-23 (IL-23) — that play a major role in inflammation. By targeting these proteins, the medication helps to lower inflammation and relieve symptoms from autoimmune conditions.
Drug facts
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Side effects of Stelara (ustekinumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Plaque psoriasis
- Common cold symptoms (7-8%)
- Upper respiratory tract infection (4-5%)
- Headache (5%)
Psoriatic arthritis
- Joint pain (3%)
- Nausea (3%)
Crohn's disease
- Common cold symptoms (11%)
- Redness at the injection site (5%)
- Yeast infection (5%)
- Bronchitis (5%)
Ulcerative colitis:
- Common cold symptoms (24%)
- Headache (10%)
- Stomach pain (7%)
- Flu infection (6%)
- Fever (5%)
Less Common Side Effects
- Dizziness
- Diarrhea
- Back pain
- Muscle pain
- Depression
- Sore throat
- Itchiness
- Vomiting
Stelara (ustekinumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infection: fever, muscle aches, cough, trouble breathing, weight loss, sores on the body, diarrhea, stomach pain, problems with urination, tiredness
- Severe allergic reaction: feeling faint, facial swelling, chest tightness, rash
- Brain condition: headache, confusion, vision problems, seizures
- Lung conditions: trouble breathing, cough
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The following Stelara (ustekinumab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in your skin, such as a new growth, a sore that doesn't heal, or a change in a mole
- Dry cough, shortness of breath or trouble breathing
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Diarrhea
- Dizziness
- Fatigue
- Headache
- Pain, redness, or irritation at injection site
- Runny or stuffy nose
- Sore throat
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Pros and cons of Stelara (ustekinumab)
Pros
- After the first few doses, only need a shot every 8 to 12 weeks
- Available as a prefilled syringe or vial
- Syringes can be stored at room temperature for up to 30 days
- Approved for children as young as 6 years old
Cons
- Can weaken your immune system and raise your risk of infection
- Potential to cause serious allergic reactions
- For CD and UC, the first dose must be given as an IV infusion
- Can't receive live vaccines while taking this medication
Pharmacist tips for Stelara (ustekinumab)
- Mark your injection dates on a calendar. You don’t use Stelara (ustekinumab) very often, so it can be easy to forget. Keeping track helps you stay on schedule.
- Inject Stelara (ustekinumab) under the skin in your upper arms, thighs, buttocks, or stomach area. Pick a new spot each time to avoid skin irritation. Don’t inject into skin that’s red, bruised, sore, or hard.
- Get medical help right away if you have signs of a serious allergic reaction after using Stelara (ustekinumab). These might include swelling of the face or throat, trouble breathing, or a rash.
- Tell your prescriber if you have a latex allergy. The needle cover of the Stelara (ustekinumab) prefilled syringe contains latex which could cause a reaction if you're sensitive to it.
- Stelara (ustekinumab) can weaken your immune system, making it harder to fight infections. Let your prescriber know if you have symptoms of an infection, such as a fever, cough, tiredness, muscle aches, or stomach pain.
- Contact your care team right away if you notice symptoms like headache, confusion, vision problems, or seizures. These could be signs of a rare brain condition linked to Stelara (ustekinumab).
- Stelara (ustekinumab) can affect how your body responds to vaccines. Avoid live vaccines during treatment. Talk to your prescriber before getting any type of vaccine.
- Store Stelara (ustekinumab) in its original carton in the refrigerator. If you're using the prefilled syringes, you can keep them at room temperature (up to 30°C or 86°F) for up to 30 days, but don’t put them back once they've been out of the fridge. If you’re using a vial, it should stay refrigerated until it’s time for your dose.
How to inject Stelara (ustekinumab) from a prefilled syringe:
- Make sure you know how to inject Stelara (ustekinumab) the right way. Ask your prescriber or pharmacist if you have questions.
- Clean the spot on your skin with an alcohol wipe before you inject to help prevent infection.
- When you're ready to inject, take off the needle cover from the syringe. Hold the syringe with one hand and pinch the cleaned skin with the other.
- Insert the needle into the pinched skin at about a 45-degree angle and push the plunger down with your thumb until all the liquid is injected. Then take out the needle and let go of your skin.
- Put the syringe into a sharps container. Never throw used syringes into the regular trash since it could harm someone.
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Common questions about Stelara (ustekinumab)
You can keep taking Stelara (ustekinumab) as long as it continues to help and doesn't cause serious side effects. Many people with long-term autoimmune conditions often stay on it for years. Your prescriber will check regularly to make sure it’s still safe and effective, and as long as it is, there’s usually no set time limit for how long you can stay on it.
Yes. Stelara (ustekinumab) is a biologic medication. Biologic medications are made from living sources, like cells or proteins.
Yes, Stelara (ustekinumab) is considered an immunosuppressant because it works by slowing down part of your immune system. By doing this, the medication helps reduce symptoms, but it might also make it slightly harder for your body to fight infections.
Stelara (ustekinumab) can stay in your system for months after your last dose. This is because it has a long half-life — between 15 and 45 days — meaning it takes that long for half the medication to leave your body. How long it stays can vary depending on your dose, how often you took it, and how your body processes medications.
It depends on the condition you're taking Stelara (ustekinumab) for. For example, studies show that some people saw improvement in their symptoms within 3 weeks for Crohn's disease and within 2 weeks for ulcerative colitis. But it can take a few months to feel the full effect, no matter the condition. Everyone responds differently, so be sure to follow up with your prescriber to talk about how the medication is working for you.
Weight gain isn’t a common side effect of Stelara (ustekinumab). But changes in weight can happen for other reasons, such as your medical condition, how your body responds to treatment, or other medications you might be taking. If you notice unexpected weight gain while taking this medication, talk to your prescriber.
Hair loss wasn't reported as a side effect by people using Stelara (ustekinumab) during clinical trials. If you notice hair loss while taking this medication, contact your prescriber — they can help you look into possible causes and recommend next steps.
Stelara (ustekinumab) prefilled syringes can be stored out of the refrigerator for up to 30 days as long as the temperature stays below 30°C (86°F). Once the syringe has been kept at room temperature, it shouldn't be returned to the refrigerator. Don’t use the medication if it has been left out for too long, exposed to heat or sunlight, or if you notice any changes in color or particles. Always follow the storage instructions from your pharmacist or the product label.
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Risks and warnings for Stelara (ustekinumab)
Stelara (ustekinumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infections
- Risk factors: Active, chronic, or recurrent infection | People with certain genetic mutations | Taking other medications that weaken your immune system
Stelara (ustekinumab) can raise your risk of infections, including serious ones that might need hospital care. These can be caused by bacteria, viruses, or fungi. Tell your prescriber about your medical history before starting Stelara (ustekinumab), especially if you've ever had tuberculosis (TB). Let your care team know right away if you have signs of infection, such as fever, chills, cough, or tiredness — your treatment might need to be paused until you recover.
Cancers
- Risk factors: Older adults | Taking other medications that weaken your immune system | History of skin cancer
Stelara (ustekinumab) weakens your immune system and can raise your risk of certain cancers. Some people developed skin cancer while taking this medication, especially those with a higher risk. Your care team will check your skin regularly during treatment, particularly if you have a history of cancer or other risk factors. Let your prescriber know if you’ve had cancer before or if you notice any new or changing spots on your skin.
Severe allergic reaction
Serious allergic reactions, including anaphylaxis and angioedema, have been reported with Stelara (ustekinumab). If you have a severe reaction, your care team will stop the medication and treat you right away. Get medical help immediately if you have symptoms like trouble breathing, swelling of your face or throat, or a serious rash.
Brain condition
Rare cases of a brain condition called posterior reversible encephalopathy syndrome (PRES) have been reported in people taking Stelara (ustekinumab). Symptoms can include headache, seizures, confusion, or vision changes. These symptoms can appear anywhere from a few days to months after starting the medication, sometimes even after a year or more. If you have PRES, your care team will stop the medication and provide treatment. Let your prescriber know right away if you notice any of these signs.
Vaccines
Before starting Stelara (ustekinumab), you or your child should be up to date on all recommended vaccines. While you're being treated, avoid getting live vaccines. You should also avoid the BCG vaccine during treatment, as well as for one year before starting and one year after stopping the medication. Be careful if someone in your household gets a live vaccine since it can spread and pose a risk to you. Non-live vaccines are generally safe, but they might not work as well while you're taking Stelara (ustekinumab). Check with your care team before getting any vaccines during treatment.
Lung problems
Different types of pneumonia have been reported in people taking Stelara (ustekinumab), and in some cases, these conditions were serious. Symptoms can include cough and trouble breathing. Let your care team know right away if you have new or worsening breathing problems. You might have to stop taking the medication and receive the appropriate treatment.
Stelara (ustekinumab) dosage
Syringe| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 0.5ml of 45mg/0.5ml | 1 syringe | $3,507.24 | $3,507.24 |
| 1ml of 90mg/ml | 1 syringe | $7,005.48 | $7,005.48 |
Vial| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 0.5ml of 45mg/0.5ml | 1 vial | $10,512.72 | $10,512.72 |
Typical dosage for Stelara (ustekinumab)
Plaque psoriasis
- Adults:
- Weight 220 lbs or less: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.
- Weight more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.
- Children ages 6 and older:
- Weight less than 132 lbs: The typical dose is 0.75 mg/kg of body weight injected under the skin once, then another 0.75 mg/kg four weeks later. After the second dose, 0.75 mg/kg is injected every 12 weeks.
- Weight of 132 lbs to 220 lbs: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.
- Weight more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.
Psoriatic arthritis
- Adults:
- Psoriatic arthritis only: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.
- Psoriatic arthritis with plaque psoriasis and weighing more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.
- Children ages 6 and older:
- Weight less than 132 lbs: The typical dose is 0.75 mg/kg of body weight injected under the skin once, then another 0.75 mg/kg four weeks later. After the second dose, 0.75 mg/kg is injected every 12 weeks.
- Weight of 132 lbs or more: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.
- Psoriatic arthritis with plaque psoriasis and weighing more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.
Crohn's disease and ulcerative colitis:
- Adults:
- Weight less than 121 lbs: The typical dose is 260 mg infusion into the veins once, then 90 mg injected under the skin every 8 weeks.
- Weight of 121 lbs to 187 lbs: The typical dose is 390 mg infusion into the veins once, then 90 mg injected under the skin every 8 weeks.
- Weight more than 187 lbs: The typical dose is 520 mg infusion into the veins once, then 90 mg injected under the skin every 8 weeks.
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