Sotyktu 6 mg comprimidos recubiertos con pelicula

Prospect: information for the patient

SOTYKTU 6 mg film-coated tablets

deucravacitinib

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

What is SOTYKTU

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

What is SOTYKTU used for

SOTYKTU is used for the treatment of adults with plaque psoriasis of moderate to severe severity. It is an inflammatory condition that affects the skin and can cause red, scaly, thick patches that produce itching and pain; it can also affect 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. In this way, it reduces the signs (dryness, cracking, scaling, shedding, redness, and bleeding of the skin) and can help reduce symptoms such as itching, pain, burning, stinging, and skin tightness of this condition.

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

Do not take SOTYKTU

• if you are allergic to deucravacitinib or any of the other components of this medication (listed in section 6).
• if you have an infection, including active tuberculosis (TB), and your doctor considers it necessary.

Warnings and precautions

Consult your doctor or pharmacist before starting to take SOTYKTU:

• if you currently have an infection that does not disappear or keeps recurring,
• if you have or have had tuberculosis (TB) at any time,
• if you have cancer, as your doctor will have to decide if you can continue to receive SOTYKTU,
• if you have heart problems or conditions that increase your propensity to develop cardiovascular diseases. It is not clear that SOTYKTU increases the risk of cardiovascular diseases,
• if you have had or are at risk of developing blood clots in the veins of the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). Inform your doctor if you experience swelling and pain in the leg, chest pain, or difficulty breathing, as these may be signs of blood clots in the veins. It is not clear that SOTYKTU increases the risk of blood clots,
• if you have recently been vaccinated or plan to be.

If you are unsure whether any of the above applies to you, consult your doctor, pharmacist, or nurse before taking SOTYKTU.

Children and adolescents

SOTYKTU is not recommended for children and adolescents under 18 years of age due to the fact that it has not been evaluated in this age group.

Other medications and SOTYKTU

Inform your doctor or pharmacist:

• if you are taking, have taken recently, or may need to take any other medication,
• if you have recently been vaccinated or plan to be. You should not receive certain types of vaccines (live microorganism vaccines) while taking SOTYKTU.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. This is because it is unknown how this medication may affect the baby.

Driving and operating machinery

SOTYKTU is not expected to affect your ability to drive or operate machinery.

SOTYKTU contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

SOTYKTU contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

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

If you take more SOTYKTU than you should

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

If you forgot to take SOTYKTU

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

If you interrupt treatment with SOTYKTU

Do not stop taking SOTYKTU without consulting your doctor first. If you interrupt treatment, your psoriasis symptoms may return.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience 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 fever)
• Increased blood levels of an enzyme called creatine phosphokinase (CPK)
• Sores in the mouth
• Acne-like eruptions
• Folliculitis (inflammation of hair follicles)

Rare(may affect up to 1 in 100 people)

• Chickenpox (herpes zoster)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, nurse, or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the blister pack and the outer packaging after "CAD"/"EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe that the tablets are damaged or signs of manipulation of the pharmaceutical packaging are observed.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of SOTYKTU

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

The other components are:

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

Appearance of the product and contents of the packaging

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

Film-coated tablets are supplied in blisters with or without a calendar containing 7 or 14 tablets.

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

Only some package sizes may be commercially available.

Marketing Authorization Holder

Bristol-Myers Squibb Pharma EEIG

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Responsible for Manufacturing

Swords Laboratories Unlimited Company

T/A Bristol-Myers Squibb Pharmaceutical Operations

External Manufacturing

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Last review date of this leaflet

Other sources of information

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