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Home / Patient Corner / Drug Information Sheets / Ustekinumab (Stelara®) Drug Information Sheet

Ustekinumab (Stelara®) Drug Information Sheet

What is Ustekinumab (Stelara®)?

Ustekinumab is a drug that reduces the signs and symptoms of active psoriatic arthritis, such as psoriasis and joint swelling. It is also approved for the treatment of plaque psoriasis and moderate to severe, active Crohn’s disease. Ustekinumab is commonly known as Stelara®. It is a type of drug called a biologic.

How do I take it?

Ustekinumab is injected under the skin (similar to insulin injections) initially, then 4 weeks later, then every 12 weeks.  The injections are either 45 mg or 90 mg each, depending on your weight. They are available as a prefilled syringe. You will be instructed on how to give yourself injections.

What about side effects?

The medicine can cause itching or redness near the injection site. If this happens, the discomfort should be mild. If you have pain, swelling, warmth, or discoloration near the injection site, you should contact your healthcare provider.

Allergic reactions may happen. Call your healthcare provider or 911 if you have any signs of an allergic reaction, such as rashes or hives; swollen face, eyelids, lips, or tongue; and difficulty breathing.

The most common serious side effect is infection. Ustekinumab can lower the body’s ability to fight infection.  Be sure to contact your physician if you have any signs of infection, such as fever, fatigue, cough, or red or painful skin. You may have to stop Ustekinumab while being treated for an infection. You may also have to stop if you are planning a surgery.

You will need to have a negative tuberculosis (TB) test before beginning Ustekinumab therapy. Your doctor will also check your blood to make sure you do not have Hepatitis B or C.

Make sure your doctor knows if you have any symptoms of heart disease, like shortness of breath when you lie down or exert yourself, swelling or edema of your legs, ankles, and feet, or chest pain or heaviness. This class of drugs may cause your heart disease to get worse.

Tell your doctor if you live or have lived in an area where fungal infections are more common. You may be at higher risk of getting a fungal infection while taking Ustekinumab.

You should not take a live vaccine (Flu-Mist, chicken pox vaccine, shingles vaccine) while on Ustekinumab.  The flu-shot is not a live virus and all patients should consider having this vaccination yearly.

What about other medications?

Many patients need to continue another oral medicaiton for RA, like methotrexate or plaquenil, while on Ustekinumab, and should continue to take this if advised to do so by their doctor.

Never take Ustekinumab with another TNF blocker such as etanercept (Enbrel®), or infliximab (Remicade®), or any other biologic medication used to treat RA.

When you are taking Ustekinumab, it is very important that your doctors know if you are taking any other medicine. This includes prescription and non-prescription medicines as well as birth control pills, vitamins, and herbal supplements.

What else should I know?

The Ustekinumab pen or pre-filled syringe must be refrigerated in its original container.  Do not freeze this medicine.

You must continue your regular visits to the rheumatologist. Your doctor will monitor you for any improvements in your disease and for any signs of infections. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Ustekinumab.

A Federal Drug Administration approved medication guide can be found at:

https://www.stelarainfo.com/pdf/prescribinginformation.pdf
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All information contained within the Johns Hopkins Arthritis Center website is intended for educational purposes only. Physicians and other health care professionals are encouraged to consult other sources and confirm the information contained within this site. Consumers should never disregard medical advice or delay in seeking it because of something they may have read on this website.

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