Ustekinumab (Stelara)

What ustekinumab is and how it works

Ustekinumab is a biologic medicine that blocks interleukin-12 and interleukin-23, substances in the body that cause inflammation. Current approved uses include moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis in eligible adults and pediatric patients. (1) (2)

The approved uses, minimum ages, and dosing schedules (subcutaneous or intravenous) differ by condition and patient weight. Ustekinumab is a treatment that requires close monitoring and regular follow-up visits with a healthcare provider. A specialist must confirm eligibility and the treatment plan.

Mechanism of action: how ustekinumab works

Ustekinumab is a human IgG1κ monoclonal antibody that binds to the p40 subunit shared by interleukin-12 and interleukin-23, preventing their interaction with their receptors and blocking downstream inflammatory signaling. (1)

What is Ustekinumab used for?

Before taking ustekinumab

Do not take / not appropriate for

• Do not receive ustekinumab if you have had a clinically significant hypersensitivity reaction to ustekinumab or any product excipient. (all products) (1)

Tell your clinician about

• Any current or past infections, including minor cuts, cold sores, or infections that come and go; any symptoms such as fever, cough, sore throat, chills, or flu-like symptoms.
• A history of tuberculosis (TB) or close contact with someone who has TB; if you have lived in a country where TB is common.
• Any history of cancer, prolonged immunosuppressant therapy, or extensive light therapy (PUVA) for psoriasis.
• If you are receiving or have received allergen immunotherapy (allergy shots).
• Pregnancy, plans for pregnancy, or breastfeeding.
• Any vaccinations you are scheduled to receive, have recently received, or that a household contact may need; specifically, if you have received the BCG vaccine in the past year.
• A known allergy to latex, as the needle cover on the prefilled syringe contains dry natural rubber.
• All other prescription and nonprescription medications, vitamins, supplements, and herbal products you are taking.

Ustekinumab dosage and how to take it

• Ustekinumab is administered according to an indication- and patient-specific schedule set by the specialist. Treatment should only be given to patients who will be closely monitored and have regular follow-up visits with a healthcare provider.
• The first subcutaneous dose is typically given in a healthcare setting. A healthcare provider may allow self-injection or injection by a caregiver after proper training in subcutaneous injection technique.
• Do not change the dose, route, frequency, or stop the prescribed background therapy yourself.
• Intravenous infusions are prepared, diluted, and administered by a healthcare professional in a medical facility over at least one hour.

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2)

Missed dose

Use the missed dose as soon as you remember it and then continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Overdose

If an overdose or medication error is suspected, contact the prescribing service or call the poison control helpline (1-800-222-1222). If the person has collapsed, had a seizure, has trouble breathing, or cannot be awakened, call emergency services immediately. (2)

Ustekinumab side effects

Effects vary by indication. Serious infections, hypersensitivity reactions, and possible malignancies are among the most important risks.

Serious warnings

Interactions

Pregnancy, breastfeeding, kidney/liver function, age

Monitoring

Before starting

• Evaluate patients for tuberculosis (TB) infection and treat latent TB before starting ustekinumab.
• Ensure all age-appropriate non-live immunizations are given as recommended by current guidelines.
• Assess for clinically important active infections and delay treatment until the infection resolves or is adequately treated.
• Confirm the exact diagnosis, indication, minimum age, and current patient weight to determine the correct product, route, and dosing regimen.

During treatment

• Closely monitor for signs and symptoms of active TB, serious infections, hypersensitivity reactions, and non-melanoma skin cancer.
• Monitor for signs of PRES (headaches, seizures, confusion, vision changes) and noninfectious pneumonia (persistent cough, shortness of breath).
• Reassess disease control, eligibility for continued treatment, and the patient's or caregiver's ability to correctly administer subcutaneous injections if home use is permitted.
• Monitoring of CYP450 substrate drug levels may be needed upon starting or stopping ustekinumab.

Storage

Store ustekinumab injection upright in the original container in the refrigerator and protect it from light. Do not freeze; discard any medication that has been frozen. If needed, the medication may be stored at room temperature in the original carton for a product-specific time; once stored at room temperature, do not return it to the refrigerator. Discard any unused portion left in a vial or syringe, as the product contains no preservatives.

Frequently asked questions

References

1. STELARA (ustekinumab) full prescribing information, Janssen BiotechU.S. Food and Drug Administration (DailyMed) · United States · accessed 2026-10-13 · source 1
2. Ustekinumab Injection: MedlinePlus Drug InformationMedlinePlus, U.S. National Library of Medicine · United States · dated 2026-03-15 · accessed 2026-10-13 · source 2

Brand names by country

Single-ingredient ustekinumab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries