SOTYKTU 6 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

SOTYKTU 6 mg Film-Coated Tablets

deucravacitinib

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

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.

Contents of the Package Leaflet

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

1. What is SOTYKTU and what is it used for

What is SOTYKTU

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

What SOTYKTU is used for

SOTYKTU is used to treat adults with moderate to severe plaque psoriasis. This is an inflammatory condition that affects the skin and can cause red, scaly, thick, and itchy patches, as well as affecting the scalp, nails, hands, and feet.

How SOTYKTU works

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

SOTYKTU has also been shown to improve the quality of life of patients with psoriasis. This means it should reduce the impact of your condition on daily activities, relationships, and other factors.

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), and your doctor considers it 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 keeps coming back,
• if you have or have had tuberculosis (TB),
• if you have cancer, as your doctor will need to decide if you can continue to receive SOTYKTU,
• if you have heart problems or conditions that increase your risk of developing heart disease. It is not clear if SOTYKTU increases the risk of heart disease,
• if you have had or are at risk of developing blood clots in the veins of the legs (deep vein thrombosis) or lungs (pulmonary embolism). Tell your doctor if you have swelling and pain in your leg, chest pain, or if you have difficulty breathing, 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 been vaccinated recently or are planning to be vaccinated.

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

Children and adolescents

SOTYKTU is not recommendedfor children and adolescents under 18 years of age, as 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 have been vaccinated recently or are planning to be vaccinated. You should not receive certain types of vaccines (live vaccines) while taking SOTYKTU.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 may affect the baby.

Driving and using machines

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

SOTYKTU contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

SOTYKTU contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take SOTYKTU

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist again.

The recommended dose is 6 mg taken once daily. The tablet should be swallowed whole and can be taken with or without food. Do not crush, break, or chew the tablets.

Your doctor will tell you how long you need to take SOTYKTU.

Talk to your doctor if your condition has not improved after six months of treatment.

If you take more SOTYKTU than you should

Talk to your doctor as soon as possible if you have taken more SOTYKTU than you should. You may experience some of the side effects listed in section 4.

If you forget to take SOTYKTU

If you forget to take SOTYKTU, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking SOTYKTU

Do not stop taking SOTYKTU without talking to your doctor first. If you stop taking SOTYKTU, your psoriasis symptoms 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 infection (nose and throat) with symptoms such as sore throat and nasal congestion

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• shingles (herpes zoster)

Reporting of side effects

If you experience 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. Storage of 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 the carton after "EXP". The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate.
• film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172), and yellow iron oxide (E172).

Appearance and packaging of SOTYKTU

SOTYKTU is a pink, round, biconvex film-coated tablet with "BMS 895" and "6 mg" printed at two lines on one side and no printing on the other side.

The film-coated tablets are supplied in blister packs with or without a calendar, 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

Manufacturer

Swords Laboratories Unlimited Company

Trading as Bristol-Myers Squibb Pharmaceutical Operations

External Manufacturing

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Date of last revision of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.