Sotyktu 6 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
SOTYKTU 6 mg film-coated tablets
deucravacitinib
This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What SOTYKTU is and what it is used for
- What you need to know before taking SOTYKTU
- How to take SOTYKTU
- Possible side effects
- How to store SOTYKTU
- 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, and helps reduce the inflammation associated with psoriasis.
What SOTYKTU is used for
SOTYKTU is used for the treatment of moderate to severe plaque psoriasis in adults. This is an inflammatory condition affecting the skin that can cause red, scaly, thick patches on the skin that are itchy and painful; 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), which is involved in the inflammatory 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, flaking or exfoliation, redness, and skin bleeding) and may help reduce symptoms such as itching, pain, burning, stinging, and skin tightness associated with this condition.
SOTYKTU has also been shown to improve the quality of life of patients with psoriasis. This means it should reduce the impact of the condition on daily activities, relationships, and other factors.
2. What you need to know before you start 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), and your doctor considers it important.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take SOTYKTU:
- if you currently have an infection that does not go away or keeps coming back,
- if you have or have ever had tuberculosis (TB),
- if you have cancer, as your doctor will need to decide whether you can continue receiving SOTYKTU,
- if you have heart problems or conditions that increase your risk 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 swelling and pain in your leg, chest pain, or difficulty breathing, as these may be signs of blood clots. It is not clear whether SOTYKTU increases the risk of blood clots,
- if you have recently been vaccinated or plan to be vaccinated.
If you are unsure whether any of the above apply to you, consult your doctor, pharmacist, or nurse before taking SOTYKTU.
Children and adolescents
SOTYKTU is not recommended for use in 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 need to take any other medicines,
- if you have recently been vaccinated or plan 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 become pregnant, consult your doctor before using this medicine. This is because it is unknown how this medicine may affect the baby.
Driving and using machines
SOTYKTU is not expected to affect your ability to drive or operate machinery.
SOTYKTU contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult with 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
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
The recommended dose is 6 mg taken daily. The tablet should be swallowed whole and may be taken with or without food. Do not crush, split, or chew the tablets.
Your doctor will advise you how long you need to take SOTYKTU.
Contact your doctor if your condition has not improved after six months of treatment.
If you take more SOTYKTU than you should
Contact 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 forget to take SOTYKTU
If you forget to take SOTYKTU, take your next dose at the usual time the following day. Do not take a double dose to make up for the missed dose.
If you stop taking SOTYKTU
Do not stop taking SOTYKTU without first consulting your doctor. If you interrupt treatment, your psoriasis symptoms may return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone 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 cold sores)
- increased blood levels of an enzyme called creatine phosphokinase (CPK)
- mouth ulcers
- acne-like rashes
- inflammation of hair follicles
Uncommon (may affect up to 1 in 100 people)
- shingles (herpes zoster)
Reporting of 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 leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the blister and outer packaging following "CAD"/"EXP". The expiry date refers to the last day of the month indicated.
This medicine requires no 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of SOTYKTU
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) and yellow iron oxide (E172).
Appearance of the product and contents of the pack
SOTYKTU is a pink, round, biconvex film-coated tablet, with "BMS 895" and "6 mg" printed in two lines on one side and no printing on the other side.
Film-coated tablets are supplied in blister packs with or without calendar packaging, containing 7 or 14 tablets.
Each pack contains 7, 14, 28 or 84 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization 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
Date of the most recent review of this leaflet
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.