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Stelara

Pronunciation: stel-ar’-a
Generic name: ustekinumabYOO-sti-KIN-ue-mab ]
Dosage form: subcutaneous injection single-dose prefilled syringe (45 mg/0.5 mL or 90 mg/mL), subcutaneous injection single-dose vial (45 mg/0.5 mL), intravenous Infusion single-dose vial 130 mg/26 mL (5 mg/mL)
Drug class: Interleukin inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Nov 1, 2023.

What is Stelara?

Stelara (ustekinumab) is used to treat types of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, which are all autoimmune conditions. Stelara injection is an interleukin inhibitor that 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. Stelara works by blocking the activity of IL-12 and IL-23, which reduces inflammation, pain, swelling, and skin symptoms that you may have.

Stelara is usually given as an injection under the skin (subcutaneous injection), and for Crohn’s disease and ulcerative colitis, the first dose is given as an IV infusion.

Stelara was first FDA-approved on September 25, 2009, for adults with moderate to severe psoriasis, and since then, approval has been extended to include other conditions.  Stelara is a biologic medicine and was the first brand of ustekinumab to be FDA-approved, so it is called the reference product.  An interchangeable biosimilar of ustekinumab was approved on October 31, 2023, called Wezlana.

What is Stelara used for?

Stelara is FDA-approved to treat:

Stelara side effects

Common Stelara side effects may include:

Serious Stelara side effects:

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

Serious infections may occur during treatment with Stelara. Call your doctor right away if you have signs of infection such as: 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:

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 FDA at 1-800-FDA-1088.

Warnings

You should not use this medicine if you have received a BCG (Bacillus Calmette and Guérin) vaccine within 1 year prior to, during, or 1 year following treatment.

Before you start treatment with this injection, your doctor may perform tests to make sure you do not have tuberculosis.

Serious infections may occur during treatment with Stelara. Call your doctor right away if you have signs of infection such as 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 called Posterior Reversible Encephalopathy Syndrome (PRES). Tell your doctor right away if you have a headache, confusion, vision problems, or a seizure.

Stelara injection may decrease the activity of your immune system, and there may be an increase in your risk for certain types of cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving this medicine and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with this medicine, tell your doctor if you develop any new skin growths.

Before taking this medicine

You should not use Stelara injection or infusion if you:

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 Stelara is safe for you, tell your doctor if you have:

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

Pregnancy

It is not known whether this medicine 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 breast-feed while using this medicine. It is thought that Stelara 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 should I use Stelara?

Before you start treatment with this medicine, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.  Stelara is intended for use under the guidance and supervision of your doctor. Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Crohn’s disease and ulcerative colitis the first dose of Stelara is given through a vein in the arm (intravenous infusion) in a healthcare facility by your healthcare provider. It takes at least 1 hour to receive the infusion. Your next doses will be given as an injection under the skin (subcutaneous injection).

Psoriasis or psoriatic arthritis Stelara is given as an injection under the skin (subcutaneous injection) as described below.

Injecting Stelara under your skin

Dosing information

Crohn’s disease and ulcerative colitis Stelara is given as an infusion for the first dose then as a subcutaneous injection every 8 weeks thereafter. 

Psoriasis and Psoriatic Arthritis Stelara is given as a subcutaneous injection initially and 4 weeks later, then a dose is given every 12 weeks.

Dose is dependent on the patient's weight.

For more Stelara dosing information, click on the link below.

Stelara is available as:

Subcutaneous Injection

Intravenous Infusion 

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 should I avoid while using Stelara?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using this medicine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

BCG vaccine should not be given for at least 1 year after you receive your last dose of Stelara.

Non-live vaccines (including flu shots) may not work as well during your treatment, and may not fully protect you from disease. Make sure you are current on all vaccines before you begin treatment with this medicine.

What other drugs will affect Stelara?

Other drugs may interact with Stelara, 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.

It is important to tell your doctor if you are taking any of the following: 

Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Not all possible interactions are listed here.

Storage

Stelara vials and prefilled syringes

Diluted Stelara infusion 

Ingredients

Active ingredient: ustekinumab 

Inactive ingredients: 

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

Single-dose vial for subcutaneous use: L-histidine, L-histidine hydrochloride monohydrate, Polysorbate 80 and sucrose. 

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

Manufacturer

Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864

Popular FAQ

Yes, Stelara was approved by the FDA on October 21, 2019 for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). This was the fifth approved use for this medicine. UC is a serious and long-term inflammatory disease that affects the large intestine (colon) and rectum. Continue reading

Yes, Stelara (ustekinumab) is an immunosuppressant. It is approved to treat certain forms of psoriasis, psoriatic arthritis and moderate to severe Crohn's disease and ulcerative colitis. Continue reading

Yes, Stelara (ustekinumab) is a biologic. This biologic drug blocks proteins that lead to inflammation. Continue reading

More FAQ

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Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Stelara only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.