Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using SOTYKTU?
SOTYKTU contains the active ingredient deucravacitinib.
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 other areas of your body such as scalp, nails, hands,
and feet. For more information, see Section
1. Why am I using SOTYKTU? in the full CMI.
2. What should I know before I use SOTYKTU?
Do not use if you have ever had an allergic reaction to deucravacitinib or any of
the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
4. How do I use SOTYKTU?
The recommended dose of SOTYKTU is one 6 mg tablet taken by mouth once a day.
Swallow the tablet whole. Do not crush, cut or chew the tablet.
It does not matter if you take this medicine before or after food.
5. What should I know while using SOTYKTU?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using SOTYKTU.
Tell your doctor if you currently have an infection that does not go away or that
keeps coming back
|
|
Things you should not do
|
Do not stop taking SOTYKTU without talking to your doctor first.
|
|
Driving or using machine
|
Be careful before you drive or use any machines or tools until you know how SOTYKTU
affects you.
This medicine is not likely to affect you being able to drive, cycle or use any tools
or machines.
|
|
Looking after your medicine
|
Store below 30°C
|
6. Are there any side effects?
Common side effects include a cold, sore throat, runny or blocked nose, cough, sores
in the mouth, cold sore blisters, acne-like rash and inflammation of hair follicles.
Serious infections with fever, flu-like symptoms, tiredness, shortness of breath or
cough which will not go away may need medical attention.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient: deucravacitinib (due-krav-a-sye-ti-nib)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SOTYKTU. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using SOTYKTU.
Where to find information in this leaflet:
1. Why am I using SOTYKTU?
SOTYKTU contains the active ingredient deucravacitinib.
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 other areas of your body such as scalp, nails, hands,
and feet.
It works by selectively blocking the activity of an enzyme called tyrosine kinase
2 (TYK2) which is involved in the process of inflammation. By reducing the activity
of this enzyme, SOTYKTU can help to control the inflammation associated with psoriasis
and reduce the signs and symptoms of this condition.
2. What should I know before I use SOTYKTU?
Warnings
Do not use SOTYKTU if:
you are allergic to deucravacitinib, or any of the ingredients listed at the end of
this leaflet.
always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
currently have an infection that does not go away or that keeps coming back. SOTYKTU
may lower the ability of your immune system to fight infections and may increase your
risk of infections.
have or had hepatitis B or C
have or had tuberculosis. If you develop any of the symptoms of tuberculosis (a dry
cough that doesn't go away, weight loss, fever, night sweats) call your doctor right
away. Your doctor may test you for tuberculosis before starting SOTYKTU.
have cancer, because your doctor will have to decide if you can still be given SOTYKTU
recently had or plan to have a vaccination
have problems with your liver
have any other medical conditions
take any medicines for any other condition
Tell your doctor if you have unexplained muscle pain, tenderness or weakness, particularly
if you have general body discomfort or fever.
Your doctor may take blood tests before you start treatment with SOTYKTU and while
you are taking it. Depending on the results of your blood tests your doctor may suspend
or discontinue treatment or prescribe you additional medicines.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
If you are pregnant, 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.
It is not known if SOTYKTU passes through breastmilk. Talk to your doctor if you are
breastfeeding or intend to breastfeed.
Use in children or adolescents
This medicine is not recommended for use in children and adolescents under 18 years.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SOTYKTU.
4. How do I take SOTYKTU?
How much to take
The recommended dose of SOTYKTU is one 6 mg tablet taken by mouth once a day.
Swallow the tablet whole. Do not crush, cut or chew the tablet.
It does not matter if you take this medicine before or after food.
Follow the instructions provided and use SOTYKTU until your doctor tells you to stop.
SOTYKTU comes in a calendar pack with the days of the week marked on it to help you
remember to take your medicine each day. All of the tablets in the pack are the same.
If you forget to use SOTYKTU
SOTYKTU should be used regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much SOTYKTU
If you think that you have used too much SOTYKTU, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using SOTYKTU?
Things you should do
Keep all of your doctor’s appointments so that your progress can be checked.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being treated with SOTYKTU.
Tell your doctor immediately if you become pregnant while being treated with SOTYKTU
Call your doctor straight away if you:
experience shortness of breath, wheezing or difficulty breathing, swelling of the
face, lips, tongue or other parts of the body; rash; itching; or hives on the skin.
These could be symptoms of serious allergic reaction.
currently have an infection that does not go away or that keeps coming back.
develop any of the symptoms of tuberculosis (a dry cough that doesn't go away, weight
loss, fever, night sweats).
Remind any doctor, dentist or pharmacist you visit that you are using SOTYKTU.
Things you should not do
Do not stop taking SOTYKTU without talking to your doctor first.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SOTYKTU
affects you.
This medicine is not likely to affect you being able to drive, cycle or use any tools
or machines.
Looking after your medicine
Store below 30°C
Follow the instructions on the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
|
Serious side effects
|
What to do
|
|
Signs of a serious infection, such as
fever, flu-like symptoms
feeling tired or short of breath, cough which will not go away
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Other side effects
|
Very common side effects
|
What to do
|
|
upper respiratory tract infections with symptoms such as sore throat and stuffy nose
|
Speak to your doctor if you have any of these side effects and they worry you.
|
|
Common side effects
|
|
viral infection of the mouth
sores in the mouth
cold sore blisters
acne-like rashes
inflammation of hair follicles
|
|
Uncommon side effects
|
|
shingles (herpes zoster)
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What SOTYKTU contains
|
Active ingredient
(main ingredient)
|
deucravacitinib
|
|
Other ingredients
(inactive ingredients)
|
hypromellose acetate succinate, lactose, microcrystalline cellulose, croscarmellose
sodium, silicon dioxide, magnesium stearate
Film coating: Opadry II Complete Film Coating System 85F140184 Pink (PI 141510)
|
Do not take this medicine if you are allergic to any of these ingredients.
What SOTYKTU looks like
SOTYKTU is pink, round, biconvex, film-coated tablet laser printed with "BMS 895 6
mg" on one side in two lines and no content on the other side (AUST R 376290).
Each pack contains 7 or 28 film-coated tablets.
Who distributes SOTYKTU
Bristol-Myers Squibb Australia Pty Ltd
4 Nexus Court, Mulgrave,
Victoria 3170, Australia.
Toll free number: 1800 067 567
This leaflet was prepared in April 2024.
SOTYKTU is a trademark of Bristol-Myers Squibb Company.