U.S. Full Prescribing Information Medication Guide Indication U.S. Healthcare Professionals En Español
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CLEAR RESULTS FROM
A
ONCE‑DAILY
PILLSOTYKTU™ (deucravacitinib) 6mg pill

CLEAR RESULTS FROM
A
ONCE‑DAILY
PILLSOTYKTU™ (deucravacitinib) 6mg pill

CHANGE THE WAY YOU SEE
YOUR MODERATE TO SEVERE
PLAQUE PSORIASIS
If you've been thinking that you are not where you'd like to be with your moderate to severe plaque psoriasis, it may be time to consider a change. Take a look at these results for SOTYKTU, then think about scheduling a chat with your dermatologist to see if SOTYKTU may work for you.
TRAILBLAZING SKIN
CLEARANCE FROM A PILL
In two studies of moderate to severe plaque psoriasis, SOTYKTU was compared to placebo and Otezla® (apremilast). Of the 1684 adults in the studies, 841 received SOTYKTU, 421 received placebo, and 422 received Otezla. Patients were assessed at 16, 24, and 52 weeks after starting treatment.
The results? Clearer skin for more people taking SOTYKTU...
Your results may vary.
CLEAR OR
ALMOST CLEAR
skin for half of people taking SOTYKTU at 16 weeks
compared to placebo.
In one study, 50% of people taking SOTYKTU saw clear or almost
clear skin vs 9% taking placebo.
75%
CLEARER SKIN
For over half of people taking
SOTYKTU at 16 weeks
compared to placebo.
In one study, 53% of people taking SOTYKTU saw 75%
clearer skin vs 9% of people taking placebo.
Hypothetical SOTYKTU™ (deucravacitinib) patient with moderate to severe plaque psoriasis
MORE SKIN CLEARANCE THAN THE LEADING PILL*
NEARLY TWICE AS MANY PEOPLE had 90% clearer skin with SOTYKTU compared to the leading pill* in one study.
90%
CLEARER SKIN
At 24 weeks, 42% of people taking SOTYKTU saw 90% clearer skin vs 22% taking the leading pill* in one study.
In a second study, 90% skin clearance was seen by 32% of people taking SOTYKTU vs 20% of people taking the leading pill.*
*Otezla® (apremilast).
Hypothetical SOTYKTU™ (deucravacitinib) patient with moderate to severe plaque psoriasis Hypothetical SOTYKTU™ (deucravacitinib) patient with moderate to severe plaque psoriasis
START LOVING YOUR SCALP
INSTEAD OF HIDING IT
If you have psoriasis plaques on your scalp, you know it can be a hard-to-treat area. It may be painful and can come with itching and flaking that can be embarrassing. The good news is, SOTYKTU has shown effective results for the scalp and may be the treatment option you've been looking for.
Illustration of an example of moderate to severe plaque psoriasis on the scalp
SOTYKTU helped more people have a CLEARER SCALP compared to the leading pill.* You can tip your hat to that. Just look at the stats.
In one study, the percentage of people with a CLEAR OR ALMOST CLEAR SCALP at 16 weeks:
70%of people
SOTYKTU
39%of people
THE LEADING PILL*
In a second study, 60% of people taking SOTYKTU vs 37% of people taking the leading pill* saw a clear or almost clear scalp at 16 weeks.
No significant difference in fingernail psoriasis was seen vs placebo at 16 weeks.
Your results may vary.
*Otezla® (apremilast).
CLEARANCE RESPONSE MAINTAINED
AT 1 YEAR
In a study, 70% of people (83 out of 118) who were clear
or almost clear at Week 24 SUSTAINED THOSE
RESULTS AT 1 YEAR
RELIEF FROM A
WIDE RANGE
OF SYMPTOMS
You may experience the pain, itching, burning, stinging, and skin tightness associated with moderate to severe plaque psoriasis. But the discomfort may be combined with frustration if your symptoms are making it difficult to go about your daily life.
In studies, more adults on SOTYKTU (8% vs 1% for placebo) reported relief of bothersome symptoms of moderate to severe plaque psoriasis at 16 weeks compared to placebo.
Study results for relief of symptoms when taking SOTYKTU™ (deucravacitinib) vs placebo
Your results may vary.
There was no significant difference in complete relief from bothersome symptoms vs the leading pill at 16 weeks.*
There was no significant difference in complete relief from bothersome symptoms vs the leading pill at 16 weeks.*

*Otezla® (apremilast).
Your results may vary.
GET A CLOSER LOOK AT SOTYKTU
SOTYKTU works differently* than other treatments.
Want to see how SOTYKTU works inside the body?
LEARN WHAT MAKES IT DIFFERENT
*Selective TYK2 inhibitor.
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.
Look out for the following icons as you read:
Talk to your dermatologist
Call a dermatologist right away
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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SOTYKTU and SOTYKTU logo are trademarks of
Bristol-Myers Squibb Company.
All other trademarks are property of their respective owners.
© 2023 Bristol-Myers Squibb Company.
1787-US-2200141 09/22
Legal Notice|Privacy Policy|Site Map
This website is intended for U.S. residents
18 years of age or older.
SOTYKTU and SOTYKTU logo are trademarks of Bristol-Myers Squibb Company.
All other trademarks are property of their respective owners.
© 2023 Bristol-Myers Squibb Company.
1787-US-2200141 09/22
Legal Notice|Privacy Policy|Site Map
This website is intended for U.S. residents
18 years of age or older.

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