Stelara (ustekinumab) 45 mg and 90 mg solution for injection and 130 mg concentrate for infusion – for psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis

Stelara is a biologic medicine containing ustekinumab, a monoclonal antibody from the group of immunosuppressants (interleukin inhibitors). It works by weakening the part of the immune system involved in inflammation and is used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

In Serbia it is authorised as solution for injection in a pre-filled syringe, 45 mg/0.5 mL and 90 mg/mL, for subcutaneous use, and as concentrate for solution for infusion, 130 mg/26 mL, given into a vein in a healthcare facility as the starting dose for Crohn’s disease and ulcerative colitis. Treatment is carried out under the supervision of a doctor experienced in these diseases.

What is Stelara used for and how is it given?

Basic information about the medicine

What is Stelara used for?

• Plaque psoriasis – moderate to severe, in adults who cannot use other medicines (ciclosporin, methotrexate) or phototherapy or in whom these have not worked, and in children and adolescents from 6 years who do not tolerate phototherapy or other systemic treatments or in whom these have not given satisfactory results.
• Psoriatic arthritis in adults – when the response to other medicines is insufficient; reduces signs and symptoms, improves physical function and slows joint damage.
• Crohn’s disease (moderate to severe) in adults – when other medicines do not work well enough or are not tolerated.
• Ulcerative colitis (moderate to severe) in adults – when other medicines do not work well enough or are not tolerated.

How is Stelara used and dosed?

Your doctor decides the dose and duration of treatment. According to the leaflet:

• Subcutaneous treatment is started by a doctor or nurse; after training and in agreement with the doctor, patients can give the injections themselves at home.
• Before injecting, let the syringe stand at room temperature for about half an hour; do not shake it. The solution must not be discoloured, cloudy or contain visible particles (a few small translucent or white protein particles are acceptable).
• The medicine is for single use; it is not mixed with other injectable liquids.

Special patient groups

• Children: in psoriasis from 6 years; not recommended in children under 6 with psoriasis, or under 18 with psoriatic arthritis, Crohn’s disease or ulcerative colitis.
• People aged 65 and over: may be more prone to infections.

Contraindications – when the medicine must not be used

• allergy to ustekinumab or any of the excipients;
• an active infection that the doctor considers important.

Precautions and warnings

The doctor checks your health before starting and before each dose and tests for tuberculosis. Tell your doctor:

• if you have been in contact with someone who may have tuberculosis, have or recently had an infection, or have open wounds;
• if you have ever had cancer, or have treated psoriasis with other biologic medicines – the risk of cancer may be increased;
• if you have a new skin lesion or a change in an existing one;
• if you are allergic to latex or have had an allergic reaction to a Stelara injection;
• if you have received other immunosuppressants or phototherapy (UV light), or injections to treat allergies;
• if you are 65 or older.

Lupus-like reactions, as well as heart attack and stroke in patients with psoriasis, have been reported – the doctor regularly checks risk factors. Seek help immediately for chest pain, weakness or an unusual sensation on one side of the body, facial muscle weakness or speech or vision disturbances.

Interactions with other medicines, food and drink

• Tell your doctor about all medicines you take and about recent or planned vaccinations – live vaccines must not be given during treatment.
• If you received Stelara during pregnancy, tell your baby’s doctor before vaccination: live vaccines (e.g. BCG) are not recommended for the baby in the first six months unless the doctor advises otherwise.
• Use together with other immunosuppressants or phototherapy has not been studied and may further weaken the immune system.

Pregnancy and breastfeeding

• Use during pregnancy should preferably be avoided. The medicine can cross the placenta, and a baby exposed to it may have a higher risk of infection.
• Women of childbearing potential should avoid pregnancy and use contraception for at least 15 weeks after the last dose.
• Ustekinumab may pass into breast milk in very small amounts – decide about breastfeeding together with your doctor.

Driving and using machines

• Stelara has no or negligible influence on the ability to drive and use machines.

Possible side effects

• Serious side effects: severe allergic reactions (rare) – difficulty breathing or swallowing, low blood pressure, swelling of the face, lips, mouth or throat; rarely allergic lung reactions and lung inflammation; infections, including opportunistic ones (brain, lungs, eye) and tuberculosis; peeling of the skin over large areas (exfoliative dermatitis, erythrodermic psoriasis).
• Very common/common: nose and throat infections, cold (more than 1 in 10); diarrhoea, nausea, vomiting, tiredness, dizziness, headache, itching, back, muscle or joint pain, sore throat, redness and pain at the injection site, sinus infection (up to 1 in 10).
• Uncommon (up to 1 in 100): chest infection, cellulitis, shingles, tooth infection, vaginal yeast infection, depression, blocked nose, bleeding, bruising, hardening and itching at the injection site, weakness, facial palsy (Bell’s palsy), pustular psoriasis, skin peeling, acne, rash and hives.
• Rare and very rare: exfoliative dermatitis, vasculitis, bullous pemphigoid, cutaneous lupus or lupus-like syndrome.

Overdose, missed dose and stopping treatment

• Overdose: if you have received more medicine than prescribed, contact your doctor or pharmacist immediately and bring the medicine pack.
• Missed dose: contact your doctor or pharmacist; do not take a double dose.
• Stopping treatment: stopping suddenly is not dangerous, but symptoms of the disease may return – the doctor decides on stopping.

Related information

In psoriasis, regular skin care, avoiding skin injuries and regular dermatology check-ups are important; in Crohn’s disease and ulcerative colitis, gastroenterology check-ups. For skin care in psoriasis, see also the category Eczema and Psoriasis – Care for Dry, Irritated and Atopic Skin – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substance: ustekinumab – 45 mg in 0.5 mL or 90 mg in 1 mL of solution (syringe); 130 mg in 26 mL of concentrate (vial).
• Excipients (syringe): L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injections.
• Appearance: clear to slightly opalescent, colourless to light yellow solution; may contain a few small translucent or white protein particles.
• Pack: 1 mL glass syringe with attached needle, a needle cover made of dry natural rubber (a latex derivative) and a passive safety guard – 1 syringe per carton; concentrate: 26 mL glass vial.
• Marketing authorisation holder: Predstavništvo Janssen-Cilag Kft Beograd, Omladinskih brigada 88B, Belgrade – Novi Beograd. Manufacturer: Janssen Biologics B.V., Einsteinweg 101, Leiden, Netherlands or Cilag AG, Hochstrasse 201, Schaffhausen, Switzerland.
• Authorisation numbers: 45 mg/0.5 mL – 000457049 2023; 90 mg/mL – 000457050 2023, both dated 5 July 2024; 130 mg/26 mL – 515-01-03608-22-001 dated 20 September 2023.

Storage

• Store in a refrigerator (2–8 °C). Do not freeze. Keep the syringe in the outer carton to protect from light. Do not shake.
• If needed, a single syringe may be stored once at room temperature up to 30 °C for at most 30 days (not beyond the expiry date on the carton) and is not returned to the fridge.
• Shelf life: 3 years. Keep out of the sight and reach of children; dispose of used syringes and unused medicine as advised by your pharmacist, not in household waste.

Frequently asked questions

How often is Stelara given?

In psoriasis and psoriatic arthritis, the first dose is followed by a dose after 4 weeks and then every 12 weeks. In Crohn’s disease and ulcerative colitis, after the intravenous infusion the first subcutaneous 90 mg dose is given after 8 weeks, then every 12 (in some patients every 8) weeks.

Can I inject myself?

Yes, after training and in agreement with your doctor. Treatment is started by a doctor or nurse, and the instructions for self-injection are at the end of the patient leaflet.

Can I be vaccinated during treatment?

Live vaccines must not be given during treatment with Stelara. Discuss any planned vaccination with your doctor. If you received the medicine during pregnancy, the baby should not receive live vaccines (e.g. BCG) in the first six months unless the doctor advises otherwise.

Is it dangerous to stop treatment?

According to the leaflet, it is not dangerous to stop Stelara suddenly, but the symptoms of the disease may come back. Your doctor decides on stopping or changing treatment.

Sources

• ALIMS – Patient information leaflet Stelara 45 mg/0,5 mL i 90 mg/mL (PIL)
• ALIMS – Summary of product characteristics Stelara 45 mg/0,5 mL i 90 mg/mL (SmPC)
• ALIMS – Patient information leaflet Stelara 130 mg/26 mL (PIL)
• ALIMS – Summary of product characteristics Stelara 130 mg/26 mL (SmPC)

Sources checked on: 25 October 2026.