Sotyktu

Package leaflet: Information for the patient

SOTYKTU 6 mg film-coated tablets

deucravacitinib
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any adverse reactions you experience while taking this medicine. See the end of section 4 for information on how to report adverse reactions.
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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 reduce the inflammation associated with
psoriasis.
What SOTYKTU is used for
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, and painful patches on the
skin, and may 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),
which is involved in the inflammatory process. By reducing the activity of this enzyme, SOTYKTU can
help control the inflammation associated with plaque psoriasis and thereby reduce signs
(dryness, cracking, flaking, desquamation or peeling, redness, and bleeding) and thus help
alleviate symptoms of this condition such as itching, pain, burning, stinging, and skin tightness.
SOTYKTU has also been shown to improve the quality of life of patients with psoriasis. This means
that the impact of this condition on daily activities, relationships, and other factors should be less than before.

2. What you need to know before taking SOTYKTU

Do not take SOTYKTU

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

Warnings and precautions
Talk to your doctor or pharmacist before taking SOTYKTU:

• if you currently have an ongoing infection that does not resolve or keeps recurring;
• if you have or have had tuberculosis (TB);
• if you have cancer, as your doctor will need to decide whether you can still take SOTYKTU;
• if you have heart problems or medical conditions that increase the likelihood of developing heart disease – it is not clear whether SOTYKTU increases the risk of heart disease;
• if you have had or are at risk of developing blood clots in the veins of your legs (deep vein thrombosis) or in your lungs (pulmonary embolism). Inform your doctor if you experience painful swelling of the legs, chest pain, or shortness of breath, as these may be signs of blood clots. It is not clear whether SOTYKTU increases the risk of blood clots;
• if you have recently received or are planning to receive a vaccination.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor, pharmacist, or nurse before using SOTYKTU.
Children and adolescents
The use of SOTYKTU is not recommended in children and adolescents under 18 years of age, as it has not been evaluated in this age group.
Other medicines and SOTYKTU
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines;
• if you have recently received or are planning to receive a vaccination. While taking SOTYKTU, you must not receive certain types of vaccines (live vaccines).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine. This is because it is not known whether this medicine may affect the unborn or breastfed child.
Driving and using machines
SOTYKTU is not expected to affect your ability to drive or operate machinery.
SOTYKTU contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
SOTYKTU contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take SOTYKTU

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is 6 mg daily. The tablet should be swallowed whole and may be
taken with or without food. Do not crush, cut or chew the tablets.
Your doctor will decide how long you should use SOTYKTU.
If your condition does not improve after six months of treatment, consult your doctor.
If you take more SOTYKTU than you should
If you take more SOTYKTU than prescribed, contact your doctor as soon as possible. You may experience
some of the side effects listed in section 4.
If you forget to take SOTYKTU
If you forget to take SOTYKTU, simply take your next dose as usual the following day. Do not take a double
dose to make up for the missed tablet.
If you stop taking SOTYKTU
Do not stop treatment with SOTYKTU without first talking to your doctor. If you stop treatment,
psoriasis symptoms may return.
If you have any questions about how to use this medicine, consult 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)

• infections of the upper respiratory tract (nose and throat), with symptoms such as sore throat and nasal congestion

Common (may affect up to 1 in 10 people)

• viral infection of the mouth (such as cold sores)
• increased blood levels of an enzyme called creatine phosphokinase (CPK)
• mouth ulcers
• acne-like skin rashes
• inflammation of hair follicles

Uncommon (may affect up to 1 in 100 people)

• shingles (herpes zoster)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, nurse, or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex 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 stated on the blister and carton after Exp./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 that the tablets are damaged or if there are any signs of tampering with the packaging.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SOTYKTU contains
The active substance is deucravacitinib. Each film-coated tablet contains 6 mg of
deucravacitinib.
The other components are

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

Description of the appearance of SOTYKTU and contents of the pack
SOTYKTU is a round, biconvex, pink, film-coated tablet with the markings “BMS 895” and “6 mg” printed in two lines on one side and no marking on the other side.
The film-coated tablets are supplied in calendar or non-calendar blister packs 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
T/A Bristol-Myers Squibb Pharmaceutical Operations
External Manufacturing
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

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Tel: + 359 2 4942 480 Tél/Tel: + 32 2 352 76 11
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Bristol-Myers Squibb spol. s r.o. Bristol-Myers Squibb Kft.
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Bristol-Myers Squibb Denmark A.M. Mangion Ltd
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Bristol-Myers Squibb GmbH & Co. KGaA Bristol-Myers Squibb B.V.
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Bristol-Myers Squibb A.E. Bristol-Myers Squibb GesmbH
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Bristol-Myers Squibb, S.A. Bristol-Myers Squibb Polska Sp. z o.o.
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Ireland Slovenia
Bristol-Myers Squibb Pharmaceuticals Ltd Swixx Biopharma d.o.o.
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Vistor hf. Swixx Biopharma s.r.o.
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[email protected]
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Bristol-Myers Squibb S.r.l. Oy Bristol-Myers Squibb (Finland) Ab
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Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.