Stelara (ustekinumab) is a monoclonal antibody that inhibits interleukin-12 and interleukin-23. It is an agent approved by the Food and Drug Administration (FDA) to manage many autoimmune diseases, including Crohn’s disease, plaque and psoriatic psoriasis, and ulcerative colitis. It is sometimes used off-label to treat moderate to severe hidradenitis suppurativa. Stelara is available as an intravenous solution and a subcutaneous injection in a vial and prefilled syringe formulation. Safety concerns associated with Stelara include its effect on the immune system, causing immunosuppression and thus increasing the risk of infection. The medication can also cause hypersensitivity reactions, infusion-related reactions, and may increase the risk for malignancy. Posterior Reversible Encephalopathy Syndrome (PRES) is a very rare condition that may occur within a few days to even months after initiation of therapy with Stelara.
Stelara overview
BRAND NAMES:
Stelara
Generic Names:
Ustekinumab
Uses:
Treats Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Therapeutic Classes:
Immunological agent
Forms:
Injectable
How it’s taken:
By injection
What is Stelara used for?
Stelara is used to treat autoimmune diseases like Crohn’s disease, ulcerative colitis, and forms of psoriasis. It may be used off-label for other conditions like hidradenitis suppurativa.
Key takeaways
Stelara can cause serious side effects, including an increased risk of infections. Infections include those caused by viruses, fungi, or bacteria. Candidates for Stelara should be evaluated for active and latent tuberculosis prior to its initiation.
Stelara can cause serious allergic reactions that are either immediate or delayed. Report any new symptoms to a healthcare professional.
The prefilled syringe formulation of Stelara contains latex. Those sensitive to latex should not handle the needle cover.
Pay attention to Stelara's storage requirements. The vials and prefilled syringes require refrigeration but must not be frozen.
For the subcutaneous formulation, rotate administration sites between the upper arms, buttocks, thighs, and abdomen.
What form(s) does Stelara come in
Single-dose prefilled syringe for subcutaneous use
45mg/0.5mL
90mg/mL
Single-dose vial for subcutaneous use
45mg/0.5mL
Single-dose vial for intravenous infusion
130mg/26mL
What are common Stelara doses?
Crohn’s Disease and Ulcerative Colitis, Adult, Initial dose:
Weight less than or equal to 55 kg: 260 mg as a single intravenous infusion
Weight greater than 55 kg to 85 kg: 390 mg as a single intravenous infusion
Weight greater than 85 kg: 520 mg as a single intravenous infusion
Crohn’s Disease and Ulcerative Colitis, Adult, Maintenance dose:
90 mg subcutaneous injection 8 weeks after the initial intravenous dose, then every 8 weeks
Psoriasis (plaque and psoriatric), Adult
Weight less than or equal to 100 kg: 45 mg administered subcutaneously initially, 4 weeks later, then every 12 weeks
Weight greater than 100 kg: 90 mg administered subcutaneously initially, 4 weeks later, then every 12 weeks
Plaque Psoriasis, Pediatrics age 6 to 17 years old
Weight less than 60 kg: 0.75 mg/kg administered subcutaneously initially, 4 weeks later, then every 12 weeks
Weight 60 kg to 100 kg: 45 mg administered subcutaneously initially, 4 weeks later, then every 12 weeks
Weight greater than 100 kg: 90 mg administered subcutaneously initially, 4 weeks later, then every 12 weeks
Common Stelara prescriptions
Stelara
0.5ml of 45mg/0.5ml syringeStelara
1ml of 90mg/ml syringeStelara
0.5ml of 45mg/0.5ml vialStelara
26ml of 130mg/26ml vial
How to take Stelara
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
A nurse or other health provider will give you this medicine.
You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
Use a new needle and syringe each time you inject your medicine.
The medicine should be clear to slightly yellow in color. Do not use the medicine if it is cloudy, discolored, or has large particles in it. Do not shake the medicine.
Crohn's disease: You will receive your first dose of this medicine in a medical setting. This is injected through a vein by your doctor. Then after 8 weeks, you will receive a maintenance dose that is injected under your skin and every 8 weeks thereafter.
If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in the original carton until you can use it. Store vials standing up straight.
This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
What to do if you miss a dose of Stelara
Inject the missed dose as soon as you remember, and then maintain your regular scheduled time with the next dose. If it has been more than 5 days since the injection was due, contact your healthcare provider for instructions on what to do.
Stelara contraindications
This medicine is not right for everyone. Do not use it if you have an allergic reaction to ustekinumab.
Stelara warnings
Keep all medicine out of the reach of children. Never share your medicine with anyone.
Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
This medicine may cause the following problems:
Increased risk of infection
Increased risk of cancer (including skin cancer)
Posterior reversible encephalopathy syndrome (PRES)
Non-infectious pneumonia
Tell your doctor if you are pregnant or breastfeeding or if you have any type of infection or a history of cancer. Tell your doctor if you have tuberculosis (TB) a history of TB, or have been in close contact with someone who has active TB. Tell your doctor if you have an allergy to latex. Tell your doctor if you have any new or changing lesions within psoriasis areas or on normal skin or have received phototherapy for your psoriasis.
Stelara interactions
Keep all medicine out of the reach of children. Never share your medicine with anyone.
This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccine. Tell your doctor if you have received the BCG vaccine or if anyone in your family is given any vaccine.
Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
Some medicines can affect how ustekinumab works or can increase side effects associated with its use. Tell your doctor if you are using immunosuppressing medications like cyclosporine and tacrolimus.
Stelara side effects
Any new or worsening medical problems should be reported to a provider immediately, including new rashes or skin eruptions. Headaches, confusion, vision problems, or seizures warrant a trip to the emergency room for immediate intervention.
Serious side effects
Diarrhea, stomach pain
Headache, seizures, confusion, blurred vision
Fever, chills, cough, sore throat, stuffy or runny nose, body aches
Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
Chest pain or tightness, troubled breathing
Burning feeling when urinating, change in how much or how often you urinate
Less serious side effects
Redness, pain, swelling, or itching where the shot was given
Headache with no other symptoms
Sources:
Hypersensitivity reaction to ustekinumab in pediatric and young adult inflammatory bowel disease patients: a case series, JPGN Reports (2022)
Immediate infusion reaction to intravenous ustekinumab in three Crohn’s Disease patients: a case report and review of the literature, Journal of Crohn’s & Colitis (2021)
Risk of malignancy in patients with psoriasis receiving systemic medications: a nested case-control study, Dermatologic Therapy (2022)
Ustekinumab-associated posterior reversible encephalopathy syndrome in a patient with Crohn’s Disease, ACG Case Reports Journal (2022)
Serial Quantiferon-TB Gold testing in patients with psoriasis treated with ustekinumab, PloS One (2017)
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