Stelara

Generic name: Ustekinumab
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

Usage of 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.

Stelara side effects

Common Stelara side effects may include:

fever, flu-like symptoms;

infection;

itching;

stomach pain, nausea, vomiting, diarrhea;

vaginal itching or discharge;

pain or burning when you urinate;

cough with mucus, shortness of breath, chest discomfort;

headache, tiredness; or

redness at the injection site.

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:

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; or

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 FDA at 1-800-FDA-1088.

Before taking Stelara

You should not use Stelara injection or infusion if you:

are allergic to the active ingredient ustekinumab or any of the inactive ingredients contained in the medicine. Click here for a full list of Stelara ingredients

have active tuberculosis; or

have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.

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:

signs of infection (fever, chills, cough, muscle aches, painful skin sores, diarrhea, pain when you urinate, feeling very tired)

chronic infections

new or changing skin lesions

a latex allergy as the needle cover on the prefilled syringe contains latex

phototherapy (light therapy)

allergy shots

if you recently received or are scheduled to receive any vaccine, people who take this medicine should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems.

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.

Relate drugs

How to use Stelara

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.

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.

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:

anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven)

medications that suppress the immune system such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), sirolimus (Rapamune), and tacrolimus (Astagraf, Envarsus, Prograf)

oral steroids such as dexamethasone (Hemady), methylprednisolone (Medrol), and prednisone (Rayos).

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.

Disclaimer

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