Otulfi
Otulfi (ustekinumab or ustekinumab-aauz) is a biologic medication and a biosimilar to Stelara (ustekinumab). Like Stelara (ustekinumab), it's FDA approved to treat several autoimmune conditions, such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It works by lowering inflammation through blocking proteins in the body called interleukins. The medication is typically given as an injection under the skin, with doses spaced every 8 to 12 weeks based on your condition. Common side effects include tiredness, headache, and cold-like symptoms.
What is Otulfi (ustekinumab)?
What is Otulfi (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 Otulfi (ustekinumab) works
Otulfi (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
Side effects of Otulfi (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
Otulfi (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
The following Otulfi (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 Otulfi (ustekinumab)
Pros
- Biosimilar that's interchangeable with Stelara (ustekinumab)
- Syringes can be stored at room temperature for up to 30 days
- Approved for children as young as 6 years old for certain conditions
- Stopper isn't made of natural rubber latex
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 Otulfi (ustekinumab)
- Mark your injection dates on a calendar. You don’t use Otulfi (ustekinumab) very often, so it can be easy to forget. Keeping track helps you stay on schedule.
- Inject Otulfi (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 Otulfi (ustekinumab). These might include swelling of the face or throat, trouble breathing, or a rash.
- Otulfi (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 Otulfi (ustekinumab).
- Otulfi (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 Otulfi (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 Otulfi (ustekinumab) from a prefilled syringe:
- Make sure you know how to inject Otulfi (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.
Common questions about Otulfi (ustekinumab)
Yes. Otulfi (ustekinumab) is available in the United States as of March 2025. It was approved by the FDA in September 2024.
No. Otulfi (ustekinumab) and Stelara (ustekinumab) aren't exactly the same, but they are closely related. Otulfi (ustekinumab) is a biosimilar to Stelara (ustekinumab), meaning it's made to act the same way in your body and treat the same conditions. Both medications have the same active ingredient, though they might have different inactive ingredients. While they might look a little different, they’re expected to be just as safe and effective. If you have questions comparing the two, talk to your prescriber.
Yes. Otulfi (ustekinumab) is interchangeable with Stelara (ustekinumab). That means that pharmacies can swap Otulfi (ustekinumab) for Stelara (ustekinumab) without a new prescription, making it more convenient if you want to switch.
Yes. Otulfi (ustekinumab) is a biologic medication. Biologic medications are made using living sources, such as cells or proteins, rather than being made from chemicals like regular medications.
Yes, Otulfi (ustekinumab) is an immunosuppressant because it works by calming down part of your immune system. This helps control symptoms of autoimmune conditions, but it might also make it a little harder for your body to fight off infections.
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Risks and warnings for Otulfi (ustekinumab)
Otulfi (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
Otulfi (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 Otulfi (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
Otulfi (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 Otulfi (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 Otulfi (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 Otulfi (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 Otulfi (ustekinumab). Check with your care team before getting any vaccines during treatment.
Lung problems
Different types of pneumonia have been reported in people taking Otulfi (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.
Otulfi (ustekinumab) dosage
Typical dosage for Otulfi (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 infused 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 infused 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 infused into the veins once, then 90 mg injected under the skin every 8 weeks.
How much does Otulfi (ustekinumab) cost?
$1,743.65
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