SOTYKTU 6 mg film coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What SOTYKTU is and what it is used for
2. What you need to know before you take SOTYKTU
3. How to take SOTYKTU
4. Possible side effects
5. How to store SOTYKTU
6. Contents of the pack and other information

SOTYKTU contains the active substance deucravacitinib, which belongs to a group of medicines called tyrosine kinase 2 (TYK2) inhibitors that help to reduce inflammation associated with psoriasis.

SOTYKTU is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin, which can cause red, scaly, thick, itchy, painful patches on your skin and can also affect your scalp and nails, hands, and feet.

SOTYKTU works by selectively blocking the activity of an enzyme called ‘TYK2’ (tyrosine kinase 2) which is involved in the process of inflammation. By reducing the activity of this enzyme, SOTYKTU can help to control the inflammation associated with plaque psoriasis and thereby reduce the signs (skin dryness, cracking, scaling, shedding, or flaking, redness and bleeding) and can therefore help to reduce symptoms such as itching, pain, burning, stinging, and skin tightness of this condition.

SOTYKTU has also been shown to improve the quality of life in patients with psoriasis. This means that the impact of your condition on daily activities, relationships and other factors should be less than it was before.

• if you are allergic to deucravacitinib or any of the other ingredients of this medicine (listed in section 6).
• if you have an infection, including active tuberculosis (TB) which your doctor thinks is important.

Talk to your doctor or pharmacist before taking SOTYKTU:

• if you currently have an infection that does not go away or that keeps coming back
• if you have or have ever had tuberculosis (TB)
• if you have cancer, because your doctor will have to decide if you can still be given SOTYKTU
• if you have heart problems or medical conditions that make you more likely to develop heart disease - it is not clear if SOTYKTU increases the risk of heart disease
• if you have had or are at risk of blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism). Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath as these can be signs of blood clots in the veins. It is not clear if SOTYKTU increases the risk of blood clots
• if you have recently had or plan to have a vaccination.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using SOTYKTU.

SOTYKTU is not recommended for children and adolescents under 18 years of age because it has not been evaluated in this age group.

Tell your doctor or pharmacist:

• if you are taking, have recently taken or might take any other medicines
• if you recently had or plan to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using SOTYKTU.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. This is because it is not known how this medicine will affect the baby.

SOTYKTU is not expected to affect your ability to drive or use machines.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

If you have taken more SOTYKTU than you should, talk to your doctor as soon as possible. You may get some of the side effects listed in section 4.

If you forgot to take SOTYKTU, just take the normal dose the next day. Do not take a double dose to make up for a forgotten tablet.

Do not stop taking SOTYKTU without talking to your doctor first. If you stop treatment, symptoms of psoriasis may come back.

If you get any side effects, talk to your doctor, nurse, or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

or search for MHRA Yellow Card in the Google Play or Apple App Store.

The active substance is deucravacitinib. Each film-coated tablet contains 6 mg of deucravacitinib.

The other ingredients are

• tablet core: hypromellose acetate succinate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate.
• film-coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172) and iron oxide yellow (E172).

SOTYKTU is a pink, round, biconvex, film-coated tablet printed with “BMS 895” and “6 mg” on one side, in two lines, plain on the other side.

The film-coated tablets are provided in calendar or non-calendar blisters containing 7 or 14 tablets.

Each pack contains 7, 14, 28 or 84 film-coated tablets.

Not all pack sizes may be marketed.