InfoCons Consumer Protection informs you – SOTYKTU – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

ℹ️ 1. What SOTYKTU is and what it is used for

What SOTYKTU is 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 and psoriatic arthritis .

What SOTYKTU is used for

SOTYKTU is used to treat the following inflammatory diseases:

• plaque psoriasis
• psoriatic arthritis .

Plaque 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.

Psoriatic arthritis SOTYKTU is used to treat adults with “ psoriatic arthritis ”, a disease that involves inflamed joints, and often plaque psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If these medicines do not work well enough or in case of intolerance, you may be given SOTYKTU either alone or in combination with another medicine called methotrexate, to treat your psoriatic arthritis.

How SOTYKTU works

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 psoriatic arthritis.

27 In psoriasis, this reduces 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 patient quality of life. This means that the impact of your condition on daily activities , relationships and other factors should be less than it was before.

In psoriatic arthritis, SOTYKTU reduces inflammation and can therefore help to reduce pain and stiffness, and swelling in and around your joints, and reduce signs of psoriatic skin rash. These effects can help you to control signs and symptoms of the disease, improve general physical functioning, ease your normal daily activities and overall improve your quality of life .

⚠️ 2. What you need to know before you take SOTYKTU

Do not take SOTYKTU

• 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.

Warnings and precautions 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.

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

Other medicines and SOTYKTU

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.

Pregnancy and breast-feeding

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.

Driving and using machines

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

28 SOTYKTU contains lactose

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

SOTYKTU contains sodium

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

💊 3. How to take SOTYKTU

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 6 mg taken every day. The tablet should be swallowed whole and can be taken either with or without food. Do not crush, cut, or chew the tablets.

Your doctor will decide for how long you need to use SOTYKTU .

If your condition has not improved after six months of treatment, talk to your doctor.

If you take more SOTYKTU than you should

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 forget to take SOTYKTU

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.

If you stop taking SOTYKTU

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people)

• upper respiratory tract (nose and throat) infections with symptoms such as sore throat and stuffy nose

Common (may affect up to 1 in 10 people)

• viral infection of the mouth (such as cold sores)
• an increase in the level of an enzyme in your blood called creatine phosphokinase (CPK)
• sores in mouth
• acne-like rashes
• inflammation of hair follicles

Uncommon (may affect up to 1 in 100 people)

• infection of the lungs ( pneumonia)
• shingles ( herpes zoster)
• inflammation of the airways in the lungs ( bronchitis ) 29 Reporting of side effects 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 listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store SOTYKTU

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice the tablets are damaged or there are signs of tampering with the medicine packaging.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What SOTYKTU contains

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) .

What SOTYKTU looks like and contents of the pack

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.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland 30 Manufacturer Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations External Manufacturing Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/ Belgique/Belgien N.V. Bristol -Myers Squibb Belgium S.A.

Tél/Tel: + 32 2 352 76 11 [email protected] Lietuva Swixx Biopharma UAB Tel: + 370 52 369140 [email protected] България Swixx Biopharma EOOD Teл.: + 359 2 4942 480 [email protected] Luxembourg/Luxemburg N.V. Bristol -Myers Squibb Belgium S.A.

Tél/Tel : + 32 2 352 76 11 [email protected] Česká republika Bristol -Myers Squibb spol. s r.o.

Tel: + 420 221 016 111 [email protected] Magyarország Bristol -Myers Squibb Kft.

Tel.: + 36 1 301 9797 [email protected] Danmark Bristol -Myers Squibb Denmark Tlf.: + 45 45 93 05 06 [email protected] Malta A.M. Mangion Ltd Tel: + 356 23976333 [email protected] Deutschland Bristol -Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+ 49 89 121 42 350) [email protected] Nederland Bristol -Myers Squibb B.V.

Tel: + 31 (0)30 300 2222 [email protected] Eesti Swixx Biopharma OÜ Tel: + 372 640 1030 [email protected] Norge Bristol -Myers Squibb Norway AS Tlf: + 47 67 55 53 50 [email protected] Ελλάδα Bristol -Myers Squibb A.E.

Τηλ: + 30 210 6074300 [email protected] Österreich Bristol -Myers Squibb GesmbH Tel: + 43 1 60 14 30 [email protected] España Bristol -Myers Squibb, S.A.

Tel: + 34 91 456 53 00 [email protected] Polska Bristol -Myers Squibb Polska Sp. z o.o.

Tel.: + 48 22 2606400 [email protected] 31 France Bristol -Myers Squibb SAS Tél: + 33 (0)1 58 83 84 96 [email protected] Portugal Bristol -Myers Squibb Farmacêutica Portuguesa, S.A.

Tel: + 351 21 440 70 00 [email protected] Hrvatska Swixx Biopharma d.o.o.

Tel: + 385 1 2078 500 [email protected] România Bristol -Myers Squibb Marketing Services S.R.L.

Tel: + 40 (0)21 272 16 19 [email protected] Ireland Bristol -Myers Squibb Pharmaceuticals uc Tel: 1 800 749 749 (+ 353 (0)1 483 3625) [email protected] Slovenija Swixx Biopharma d.o.o.

Tel: + 386 1 2355 100 [email protected] Ísland Vistor ehf.

Sími: + 354 535 7000 [email protected] Slovenská republika Swixx Biopharma s.r.o.

Tel: + 421 2 20833 600 [email protected] Italia Bristol -Myers Squibb S.r.l.

Tel: + 39 06 50 39 61 [email protected] Suomi/Finland Oy Bristol -Myers Squibb (Finland) Ab Puh/Tel: + 358 9 251 21 230 [email protected] Κύπρος Bristol -Myers Squibb A.E.

Τηλ: 800 92666 (+ 30 210 6074300) [email protected] Sverige Bristol -Myers Squibb Aktiebolag Tel: + 46 8 704 71 00 [email protected] Latvija Swixx Biopharma SIA Tel: + 371 66164750 [email protected]

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information SOTYKTU (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/23/1718).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.