What is ustekinumab?
Ustekinumab (Stelara, Wezlana) 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).
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 biologic medicine and was the first brand of ustekinumab approved by the FDA, and is called the reference product. Wezlana is an interchangeable biosimilar of Stelara this means that Weslana is a very close copy of Stelara. The FDA says that “Biosimilar and interchangeable biosimilar products are as safe and effective as their reference products”. An interchangeable biosimilar may be substituted for the reference product without consulting the prescriber, subject to state laws. This means that Wezlana can be dispensed when the prescription has been written for Stelara, depending on local state laws.
What is ustekinumab used for?
Ustekinumab is FDA-approved to treat:
- moderate or severe psoriasis (patients 6 years and older)
- psoriatic arthritis (patients 18 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 this medicine 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
- fever, flu-like symptoms
- headache, tiredness
- 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 FDA at 1-800-FDA-1088
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.
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.
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.
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.
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.
Active ingredient: ustekinumab
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.
Stelara: Janssen Biotech, Inc., Horsham, PA 19044, US.
Wezlana: Amgen, Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320-1799
Frequently asked questions
- What are the new drugs for plaque psoriasis?
- How many biosimilars have been approved in the United States?
- How quickly or how long before Stelara starts to work?
- How long can you keep Stelara in or out of the fridge?
- Can you get a flu shot or take antibiotics while on Stelara?
- How is Stelara injected or administered?
- What blood tests are needed for Stelara?
- April W Armstron , Manan D Mehta, Clayton W Schupp, George C Gondo 3, Stacie J Bell 3, Christopher E M Griffiths Psoriasis Prevalence in Adults in the United States JAMA Dermatology 2021 Aug 1;157(8):940-946
- Food and Drug Administration (FDA) Stelara Product Label
- Biosimilars Info Sheet. Level 2: Regulatory and Scientific Concepts
- FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases
- Alice Gottlieb and Kirti Narang. Ustekinumab in the treatment of psoriatic arthritis: latest findings and clinical potential. Ther Adv Musculoskelet Dis. 2013 Oct; 5(5): 277–285.
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