Description
Sotyktu 6 mg contains deucravacitinib, a selective oral TYK2 inhibitor supplied in this photographed European presentation as 28 film-coated tablets. It is a prescription medicine for eligible adults with immune-mediated disease. The current European Union product information includes moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy and active psoriatic arthritis in adults who have had an inadequate response or intolerance to a previous disease-modifying antirheumatic drug (DMARD). Market authorisations differ: the Great Britain product information last revised in 2024 lists plaque psoriasis only. Always follow the leaflet and approved indication for the country of the pack.
What Sotyktu 6 mg is used for
Deucravacitinib works inside immune cells by selectively inhibiting tyrosine kinase 2 (TYK2), a signalling protein involved in cytokine pathways associated with psoriasis and psoriatic arthritis. It is not a general painkiller and it is not intended for self-treatment. A clinician experienced in diagnosing and treating the relevant condition should start and supervise therapy.
For plaque psoriasis, the current EU label covers adults with moderate-to-severe disease who are candidates for systemic therapy. For psoriatic arthritis, the current EU label covers adults with active disease after an inadequate response or intolerance to one or more DMARDs; it may be used alone or with methotrexate. The older Great Britain label available through eMC lists plaque psoriasis only. This difference is regulatory, not a reason to use the medicine outside the local label.
Sotyktu 6 mg dose and administration
The recommended adult dose in the current European product information is one 6 mg tablet by mouth once daily. Take it at about the same time each day, with or without food. Swallow the tablet whole with water. Do not crush, cut or chew it because the tablet is designed to be taken intact.
- Usual dose: one tablet once daily.
- Food: may be taken with or without food.
- Missed dose: if a dose is missed, take the next normal dose on the following day. Do not take two doses to make up for a missed tablet.
- Stopping: do not stop treatment without speaking to the prescribing specialist.
Benefit should be reviewed regularly. The EU information advises considering discontinuation if there is no evidence of therapeutic benefit after 24 weeks. A prescriber may review sooner if symptoms worsen, infection develops or an adverse effect is suspected.
Essential checks before treatment
Before the first dose of Sotyktu 6 mg, tell the prescriber about all infections, previous tuberculosis (TB), close contact with a person who has TB, recent travel, recurrent herpes infections, cancer history, planned surgery, pregnancy, breastfeeding and every medicine or supplement being used.
- Active infection: treatment should not be started during a clinically important active infection.
- Tuberculosis: patients should be evaluated for TB before treatment. Active TB must be treated, and latent TB should be treated according to clinical guidance before deucravacitinib is started.
- Vaccination: complete age-appropriate immunisations before therapy where possible. Live vaccines should be avoided during treatment.
- Cancer and cardiovascular risk: discuss previous malignancy and individual cardiovascular or thromboembolic risk factors with the specialist. The long-term significance of risks observed with other medicines in the broader JAK family is still being evaluated for deucravacitinib.
- Liver health: tell the clinician about liver disease. Severe hepatic impairment is a reason the EU information does not recommend use.
Who should not take Sotyktu 6 mg?
Do not take the medicine if you are allergic to deucravacitinib or any ingredient in the tablet. It should not be started in a person with a clinically important active infection, including active tuberculosis. It is not approved for people under 18 years because safety and effectiveness in children and adolescents have not been established.
Pregnancy should preferably be avoided because human pregnancy data are limited. Deucravacitinib or its metabolites are excreted in human milk, so the prescriber and patient must decide whether to stop breastfeeding or avoid treatment after considering the benefit to the child and the benefit of therapy to the mother.
Possible side effects
The most common adverse event in clinical studies was upper respiratory tract infection, reported in about 18.9% of psoriasis participants and 15.1% of psoriatic arthritis participants in the EU product information. This can include symptoms such as sore throat, runny nose or sinus symptoms. Other common effects include herpes simplex infections, mouth ulcers, acne-like rash, folliculitis and increased blood creatine phosphokinase (CPK).
Pneumonia, shingles and bronchitis are listed as uncommon. Seek urgent medical assessment for severe or persistent fever, shortness of breath, painful blistering rash, unusual weakness, marked muscle pain, swollen glands or any sign of a serious allergic reaction. Patients should be monitored for infection during and after treatment, and treatment may need to be interrupted if a serious infection develops.
Interactions and special populations
Formal interaction studies in the European information did not identify clinically meaningful effects with several commonly studied medicines, but this does not replace a full medication review. Give the specialist and pharmacist a complete list of prescriptions, over-the-counter medicines, herbal products and supplements. Do not receive a live vaccine without specialist approval.
| Situation | Current EU guidance |
|---|---|
| Kidney impairment | No dose adjustment is required, including end-stage renal disease and dialysis. |
| Mild or moderate liver impairment | No dose adjustment is required. |
| Severe liver impairment | Use is not recommended. |
| Adults aged 65 or older | No routine dose adjustment, but clinical monitoring remains important. |
| Under 18 years | Safety and effectiveness have not been established. |
Tablet, pack and storage details
Each film-coated tablet contains 6 mg deucravacitinib and approximately 44 mg lactose. The tablet is pink, round and biconvex, approximately 8 mm in diameter, printed with “BMS 895” on one side and “6 mg” on the other. It is essentially sodium-free. The photographed presentation contains 28 film-coated tablets and carries German/Austrian dispensing information with PZN 18073809. European pack sizes can include 7, 14, 28 and 84 tablets; not every pack size is marketed in every country.
The EU product information states that no special storage conditions are required and gives a three-year shelf life. Keep tablets in the original pack, out of the sight and reach of children, and never use them after the expiry date printed on the carton. Do not dispose of unused prescription medicine in household wastewater; ask a pharmacist about local disposal arrangements.
Practical monitoring checklist
- Take Sotyktu 6 mg exactly once daily as prescribed.
- Report new infection symptoms promptly and do not ignore persistent fever.
- Keep vaccination records available; avoid live vaccines during therapy.
- Attend planned skin, joint and safety reviews.
- Review whether the medicine is providing meaningful benefit by week 24.
- Use the local pack leaflet when it differs from online information from another market.
Frequently asked questions about Sotyktu 6 mg
Is it a JAK inhibitor?
Deucravacitinib selectively targets TYK2 through a regulatory domain. TYK2 belongs to the Janus kinase family, but the medicine has a distinct binding mechanism from JAK1, JAK2 and JAK3 inhibitors. The prescriber should still assess individual infection, malignancy, cardiovascular and thrombosis risk.
Can I take it with food?
Yes. The tablet may be taken with or without food. The important points are one dose daily and swallowing the tablet whole.
Why does the EU label mention psoriatic arthritis while the GB leaflet may not?
Authorisations are updated by different regulators at different times. The current EMA information updated in June 2026 includes eligible adult psoriatic arthritis, while the Great Britain SmPC text revised in August 2024 lists plaque psoriasis only. Follow the authorised indication and leaflet for the country where the medicine is supplied.
Where can I check the official information?
Read the European Medicines Agency Sotyktu overview and current product information. For the older Great Britain label and patient leaflet, see the electronic Medicines Compendium SmPC. You can also browse other No Style Like products. Online information supports, but never replaces, advice from the prescribing specialist or pharmacist.
Medical disclaimer: This page is educational product information, not a diagnosis or a treatment recommendation. Sotyktu 6 mg is prescription only. Use only under specialist supervision and according to the local authorised leaflet.
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