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ABOUT MODERATE TO SEVERE PLAQUE PSORIASIS

A SYSTEMIC DISEASE
OF THE IMMUNE SYSTEM

Moderate to severe plaque psoriasis is a common, chronic autoimmune disease that causes red, itchy, scaly patches. The patches most commonly appear on the knees, elbows, trunk, and scalp.

While moderate to severe plaque psoriasis is visible on the outside of the body, it begins on the inside. That’s because it’s a systemic disease of the immune system, the collection of organs, cells, and proteins that help protect the body from threats. A systemic disease affects the entire body. In psoriasis, it begins in the immune system.
HOW PLAQUES
FORM
Normally, immune cells talk to each other via chemical signals. In the case of moderate to severe plaque psoriasis, these signals go out of control and speed up the growth cycle of skin cells. The rapid turnover of cells results in scales and red patches on the skin.
Illustration of a hypothetical SOTYKTU™ (deucravacitinib) patient with moderate to severe plaque psoriasis on the scalp and arm
SYMPTOMS OF MODERATE TO SEVERE PLAQUE PSORIASIS
The symptoms of moderate to severe plaque psoriasis can look different for each person, and plaques can form virtually anywhere on the body.
Illustration of examples of locations where psoriasis plaques can form on the body
Symptoms may include:
  • Red patches of skin covered with thick, silvery scales
  • Small scaling spots
  • Dry, cracked skin that may bleed or itch
  • Itching, burning, skin tightness, or soreness
DIAGNOSING AND TREATING
MODERATE TO SEVERE
PLAQUE PSORIASIS
Your primary care doctor may be able to recognize and diagnose plaque psoriasis; however, a dermatologist who specializes in skin diseases may be a beneficial supporter to add to your care team.
There are many treatments on the market for moderate to severe plaque psoriasis.
In most cases, your treatment choice will depend on the severity of your moderate to severe plaque psoriasis and how responsive you may have been to previous treatments.
Common treatments include:
  • Creams for the skin – over-the-counter or prescription treatments
  • UVB (light) therapy – involves exposing the skin to specialized ultraviolet light under medical supervision
  • Biologic injections – protein-based drugs derived from living cells cultured in a laboratory given by intravenous (IV shot), infusion (a slow drip of medicine into the vein) or injection under the skin
  • Oral therapies – typically, systemic therapies that are taken orally and target specific molecules in the immune system and work throughout the body
Hypothetical SOTYKTU™ (deucravacitinib) patient with moderate to severe plaque psoriasis
SOTYKTU (deucravacitinib) WORKS DIFFERENTLY*
SOTYKTU is the only pill that specifically targets TYK2, to help block from passing on too
many signals.
*Selective TYK2 inhibitor.
SEE HOW SOTYKTU WORKS
Important Facts About
SOTYKTU™
(deucravacitinib)
This is a summary of important information that you need to know about SOTYKTU. Your dermatologist can work with you to help answer any questions you may have about this medication. Keep this information in a safe place, so you can refer to it before and during your treatment.
This is a summary of important information that you need to know about SOTYKTU. Your dermatologist can work with you to help answer any questions you may have about this medication. Keep this information in a safe place, so you can refer to it before and during your treatment.
Look out for the following icons as you read:
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Helpful information to remember
What is SOTYKTU?
SOTYKTU is an oral prescription medication that is used to treat:
Moderate-to-severe plaque psoriasis in adults who may benefit from systemic therapy (pills or injections that work inside the body) or phototherapy (treatment using specialized ultraviolet or UV light).
It is not known if SOTYKTU is safe
and effective in children under 18
years of age.
What is the most important information I should know about SOTYKTU?
SOTYKTU may cause serious side effects, including:
Serious allergic reactions. Stop taking SOTYKTU and get emergency medical help right away if you develop
any of the following symptoms of a serious allergic reaction:
  • Feeling faint
  • Swelling of your face, eyelids,
    lips, mouth, tongue, or throat
  • Trouble breathing or
    throat tightness
  • Chest tightness
  • Skin rash, hives
Infections. SOTYKTU is a medicine that affects your immune system. SOTYKTU can lower the ability of your immune system to fight infections and can increase your risk of infections. Your dermatologist should check you for infections before starting SOTYKTU. Some people have had serious infections while taking SOTYKTU, such as infections of the lungs, including pneumonia and tuberculosis (TB) and COVID-19.
Before starting SOTYKTU, your dermatologist should check you for TB. If you have active TB or a history of TB, you may be treated for TB before beginning treatment with SOTYKTU. Your dermatologist should watch you closely for signs and symptoms of TB during treatment with SOTYKTU.
If you get a serious infection, your dermatologist may tell you to stop taking SOTYKTU until your infection is controlled.
Call or see a dermatologist if you notice any symptoms of TB.
Call or see a dermatologist right away if you have an infection or develop any new or worsening symptoms of an infection, including:
  • Fever, sweats, or chills
  • Muscle aches
  • Weight loss
  • Cough
  • Shortness of breath
  • Blood in your phlegm (mucus you cough up)
  • Warm, red, or painful skin or sores on your body different from your psoriasis
  • Diarrhea or stomach pain
  • Burning when you urinate or urinating more often than normal
  • Feeling very tired
SOTYKTU should not be used in people with an active, serious infection, including localized infections. You should not start taking SOTYKTU if you have any kind of infection unless your dermatologist tells you it is okay.
You may be at higher risk of developing shingles (herpes zoster).
Before starting SOTYKTU, tell your dermatologist if you:
  • Have any kind of infection or symptoms of an infection (see symptoms listed in “What is the most important information I should know about SOTYKTU?”), as SOTYKTU may lower the ability of your immune system to fight infections and may increase your risk of infections. Infections include:
    • Any infection for which you are currently being treated.
    • Any infection that will not go away or a history of infections that keep coming back.
    • Tuberculosis (TB), a type of lung infection. Tell your dermatologist if you have TB or have been in close contact with someone with TB.
    • Hepatitis B or C. Tell your dermatologist if you have or have had hepatitis B or C.
After you start taking SOTYKTU, call your dermatologist right away if you have an infection or symptoms of an infection. SOTYKTU can make you more likely to get infections or make any infections you have worse.
Cancer. Certain kinds of cancer including lymphoma have been reported in people taking SOTYKTU. Tell your dermatologist if you have ever had any type of cancer.
Muscle problems (rhabdomyolysis). SOTYKTU can cause muscle problems that can be severe. Treatment with SOTYKTU may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can be a sign of muscle damage. Increased CPK is common in people taking SOTYKTU. Your dermatologist may tell you to stop taking SOTYKTU if the amount of CPK in your blood gets too high or if you have signs and symptoms of severe muscle problems. Tell your dermatologist right away if you have any of these signs or symptoms of severe muscle problems:
  • Unexplained muscle pain, tenderness, or weakness
  • Feeling very tired
  • Fever
  • Dark-colored urine
A serious side effect is a side effect that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening or sometimes even fatal.
What should I discuss with my dermatologist before starting treatment?
Talk to your dermatologist about all of your medical conditions, including if:
  • You have liver or kidney problems.
  • You have high levels of fat in your blood (triglycerides).
Talk to your dermatologist if you have recently received or are scheduled to receive a vaccine (immunization).
During treatment with SOTYKTU, you should avoid receiving live vaccines (vaccines that use a small
amount of the weakened virus). Common live vaccines (among others) include:
  • Measles, mumps, and rubella (MMR)
  • Rotavirus
  • Smallpox
  • Chickenpox
  • Yellow fever
Talk to your dermatologist if:
You are pregnant or plan to become pregnant. It is not known if SOTYKTU can
harm your unborn baby.
You are breastfeeding or plan to breastfeed. It is not known if SOTYKTU passes
into your breast milk.
Tell your dermatologist if you become pregnant or think you are pregnant during treatment
with SOTYKTU. Report pregnancies to Bristol-Myers Squibb by calling 1-800-721-5072.
Talk to your dermatologist about all of the medications you are taking, including:
  • Prescription medicines
  • Over-the-counter medicines
  • Vitamins
  • Herbal supplements
Keep a list of them to show your dermatologist and pharmacist when you get a new medicine.
What are the possible side effects of SOTYKTU?
SOTYKTU may cause serious side effects, including:
  • Changes in certain laboratory test results. Changes in laboratory tests have happened in some people taking SOTYKTU. Your dermatologist may do blood tests before you start taking SOTYKTU and during treatment with SOTYKTU to check for the following:
    • Increased triglycerides. Too much fat in your blood can cause problems with your heart.
    • Increased liver enzymes. If your liver enzymes increase too much, your dermatologist may need to do additional tests on your liver and may tell you to stop taking SOTYKTU if they think that SOTYKTU is harming your liver.
  • Potential risks from Janus kinase (JAK) inhibition. SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor. TYK2 is in the JAK family. It is not known whether taking SOTYKTU has the same risks as taking JAK inhibitors. Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least 1 heart disease (cardiovascular) risk factor who were taking a JAK inhibitor used to treat rheumatoid arthritis (RA) compared to people taking another medicine in a class of medicines called TNF blockers. SOTYKTU is not for use in people with RA.
What are the most common side effects of SOTYKTU?
The most common side effects of SOTYKTU include:
  • Common cold, sore throat, and sinus infection (upper respiratory infections)
  • Cold sores (herpes simplex)
  • Sores on the inner lips, gums, tongue, or roof of the mouth (canker sores)
  • Inflamed hair pores (folliculitis)
  • Acne
These are not all of the possible side effects of SOTYKTU.
Talk to your dermatologist, pharmacist, or other members of your healthcare team for more information about side effects. If you experience any side effects and would like to report them to the FDA, you can visit www.fda.gov/medwatch or call 1-800-FDA-1088.
How should I take SOTYKTU?
Take SOTYKTU exactly as your
dermatologist tells you.
Take 1 time every day
Can be taken with or without food
Do not crush, cut, or chew the SOTYKTU tablets
SOTYKTU is available as a 6 milligram (mg) pink, round pill.
Each pill is marked with “BMS 895” and “6 mg.”
Do not take SOTYKTU if you are allergic to deucravacitinib or any of the ingredients in SOTYKTU.
Inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and silicon dioxide
Pill coating inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red and yellow
How should I store SOTYKTU?
Store SOTYKTU at room temperature between 68°F to 77°F (20°C to 25°C).
Keep SOTYKTU and all medicines out of reach of children.
For more information, please see the U.S. Full Prescribing Information and Medication Guide for SOTYKTU.
Talk to your healthcare team for more information about this medication.
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© 2023 Bristol-Myers Squibb Company.
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SOTYKTU, SOTYKTU 360 SUPPORT, and SOTYKTU logo are trademarks of Bristol-Myers Squibb Company.
All other trademarks are property of their respective owners.
© 2023 Bristol-Myers Squibb Company.
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