Ustekinumab

Pronunciation: YOO sti KIN ue mab
Generic name: Ustekinumab
Brand names: Imuldosa, Otulfi, Pyzchiva, Selarsdi, Stelara, Wezlana
Dosage form: injection for subcutaneous use, intravenous infusion
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 30, 2024.

What is ustekinumab?

Ustekinumab (Stelara, Wezlana, Selarsdi, Pyzchiva, Otulfi, Imuldosa) is used to treat certain types of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Ustekinumab helps reduce the symptoms of these diseases but does not cure these inflammatory diseases.

• Wezlana is an interchangeable biosimilar of Stelara (ustekinumab). 
• Selarsdi, Pyzchiva, Otulfi, and Imuldosa are all biosimilars to Stelara that have gained FDA approval for certain types of plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Ustekinumab works by blocking certain proteins in your body called IL-12 (interleukin-12) and IL-23 (interleukin-23) that cause inflammation in these autoimmune conditions. By ustekinumab blocking these interleukin proteins helps reduce inflammation and improves the symptoms of these autoimmune conditions. Ustekinumab is from a class of medicines called interleukin inhibitors.

Stelara is a biological medicine and was the first brand of ustekinumab approved by the FDA, and is called the reference product.

• Because Wezlana is an interchangeable biosimilar of Stelara, it may be dispensed when the prescription has been written for Stelara without consulting the prescriber, subject to state laws. 
• Because Selarsdi, Pyzchiva, Otulfi, and Imuldosa are all biosimilars to Stelara, they may be prescribed by a healthcare provider instead of Stelara for psoriasis, psoriatic arthritis, ulcerative colitis, or Crohn’s disease.

What is ustekinumab used for?

Ustekinumab is FDA-approved to treat:

• moderate or severe psoriasis (patients 6 years and older)
• psoriatic arthritis (patients 6 years and older) 
• moderately to severely active Crohn's disease (patients 18 years and older)
• moderately to severely active ulcerative colitis (patients 18 years and older)

For moderate or severe psoriasis, you will only be prescribed this medicine if your doctor believes your psoriasis will be improved by taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).

It is not known if ustekinumab is safe and effective in children less than 6 years of age.

How does ustekinumab work?

Plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis are autoimmune disorders that are caused by an overactive immune response causing inflammation and the symptoms of each condition. 

Proteins (cytokines) called IL-12 and IL-23 are involved in the inflammation and immune response.  Ustekinumab binds and inhibits IL-12 and IL-23, which reduces inflammation and helps the symptoms of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Ustekinumab is a human IgG1қ monoclonal antibody that binds with specificity to the p40 protein subunit used by the IL-12 and IL-23 cytokines.

Ustekinumab side effects

Common ustekinumab side effects

• cough with mucus, shortness of breath, chest discomfort
• Infection
• fever, flu-like symptoms
• headache, tiredness
• Itching
• redness at the injection site
• vaginal itching or discharge
• pain or burning when you urinate
• stomach pain, nausea, vomiting, diarrhea.

Serious ustekinumab side effects

Get emergency medical help if you have signs of an allergic reaction to this medicine: hives; chest pain, difficulty breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with ustekinumab. Call your doctor right away if you have signs of infection including fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

Also, call your doctor at once if you have:

• a mole that has changed in size or color
• swelling, pain, warmth, or redness anywhere on your body
• stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation)
• new or worsening cough, sudden chest pain, feeling short of breath
• pain or burning when you urinate
• severe headache, confusion, change in mental status, vision problems, and/or seizure (convulsions).

​​​​​This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Warning

You should not use this medicine if you have received a vaccine to prevent tuberculosis (BCG vaccine) within 1 year before using ustekinumab while using it, or 1 year after you have finished treatment. Before you start treatment with this medicine your doctor may perform tests to make sure you do not have tuberculosis.

When you are being treated with ustekinumab, it can make you more likely to get infections or make an infection that you have worse. Call your doctor right away if you have signs of infection, including fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.
Ustekinumab may also cause a rare but serious condition affecting the brain. Tell your doctor right away if you have a headache, confusion, vision problems, or a seizure

Before taking this medicine

You should not use ustekinumab if you are allergic to it or any of the inactive ingredients or if you have:

• active tuberculosis (TB)
• if you have received a TB vaccine (BCG vaccine) in the last year.
• tell your doctor if you have ever had tuberculosis if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure ustekinumab is safe for you, tell your doctor if you have:

• signs of infection (fever, chills, cough, muscle aches, painful skin sores, diarrhea, pain when you urinate, feeling very tired);
• chronic infection
• new or changing skin lesions
• allergy shots
• a latex allergy
• phototherapy (light therapy) or
• if you recently received or are scheduled to receive any vaccine.

Some people using this medicine have developed skin cancer (non-melanoma). However, usually, these people already may have had a higher risk of skin cancer. Talk to your doctor about your risk and what skin symptoms you should watch for. You may need to have regular skin exams.

Pregnancy

It is not known whether ustekinumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ustekinumab on the baby.

Breastfeeding

It may not be safe to breastfeed while using ustekinumab. It is thought that this medicine passes into your breast milk in small amounts. Talk to your doctor about the best way to feed your baby if you receive this medicine.

How will I receive ustekinumab? 

If you have psoriasis, you will be given ustekinumab as an injection under the skin (subcutaneous injection). Once you have had your first injection, you will have your next injection after 4 weeks, and from then on you will have an injection every 12 weeks.

If you have Crohn’s disease or ulcerative colitis, your first dose is given slowly as an infusion into a vein by your doctor or nurse. The next doses you have will be every 8 weeks as an injection under the skin (subcutaneous injection).

You will be able to inject yourself or have a caregiver give you your injection once you have been shown how to do this by your doctor or nurse.

The dose your healthcare provider will give you will depend on how much you weigh and whether you have psoriasis, Crohn’s disease or ulcerative colitis.

How to use ustekinumab

• Inject ustekinumab under the skin (subcutaneous injection) in your upper arms, buttocks, upper legs (thighs), or stomach area (abdomen).
• Do not give an injection in an area of the skin that is tender, bruised, red or hard.
• Use a different injection site each time you use ustekinumab.
• If you inject more ustekinumab than prescribed, call your doctor right away.
• Be sure to keep all of your scheduled follow-up appointments.

Related/similar drugs

Entyvio, Otezla, Sotyktu, prednisone, methotrexate, methylprednisolone, dexamethasone, hydrocortisone, hydrocortisone topical, budesonide

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What other drugs will affect ustekinumab?

Other drugs may interact with ustekinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using. Not all possible interactions are listed here.

Storage

Stelara vials and prefilled syringes 

• Refrigerate at 2°C to 8°C (36°F to 46°F). 
• Store Stelara vials upright.
• Keep the product in the original carton to protect from light until the time of use.
• Do not freeze.
• Do not shake.

Ingredients

Active ingredient: ustekinumab

Inactive ingredients:

Stelera: 

Single-dose prefilled syringe for subcutaneous use: L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, and sucrose. 

Single-dose vial for subcutaneous use contains L-histidine, L-histidine hydrochloride monohydrate, Polysorbate 80 and sucrose. Single-dose vial for intravenous infusion contains EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80, and sucrose.

Selarsdi:

Inactive ingredients (single-dose prefilled syringe for SC use): histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, L-histidine monohydrochloride monohydrate, methionine, polysorbate 80, sucrose, and water for injection.

Selarsdi is available as a 45 mg/0.5 mL single-dose prefilled syringe and a 90 mg/mL single-dose prefilled syringe.

Selarsdi is also available as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.

Imuldosa

Inactive ingredients (single-dose prefilled syringe for subcutaneous use): histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose.

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose. 

Imuldosa is available as a 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe for SC use.

Imuldosa is also available as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.

Otulfi

Inactive ingredients (single-dose prefilled syringe for subcutaneous use): histidine, polysorbate 80,
sucrose and hydrochloric acid (to adjust pH).

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, L-histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose.

Otulfi is available as a 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe for SC use.

Otulfi is also available as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.

Pyzchiva

Inactive ingredients (single-dose prefilled syringe for subcutaneous use): histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose.

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose. 

Pyzchiva is available as a 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe for SC use.

Pyzchiva is available as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.

Wezlana

Inactive ingredients (single-dose prefilled syringe for subcutaneous use): histidine, histidine hydrochloride
monohydrate, Polysorbate 80, and sucrose.

Inactive ingredients (single-dose vial for subcutaneous use): histidine, histidine hydrochloride monohydrate, Polysorbate 80, and sucrose.

Inactive ingredients (single-dose vial for intravenous infusion) edetate disodium, histidine, histidine hydrochloride monohydrate, methionine, Polysorbate 80, and sucrose.  

Company

Stelara: Janssen Biotech, Inc.

Selarsdi: Alvotech and Teva Pharmaceutical Industries.

Imuldosa: Dong-A ST and Meiji Seika Pharma.

Otulfi: Fresenius Kabi.

Pyzchiva: Samsung Bioepis Co., Ltd., makes Pyzchiva for Sandoz Inc. 

Wezlana: Amgen, Inc.

Ustekinumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for ustekinumab.

Stelara interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Stelara biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

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Further information

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