Get to Know SOTYKTU—Your Every
Day PSORIATIC ARTHRITIS Treatment

Learn more about SOTYKTU for psoriatic arthritis

Actor portraying a SOTYKTU® patient smiling while attending a yoga class.

PILL-SIZED FLEXIBILITY

Life’s busy enough. This every day pill lets you treat on your terms so it fits your routine.
  • One pill taken once each day—you decide what time
  • SOTYKTU can be taken with or without food
Actor portrayal of a SOTYKTU® patient holding a pill

SEEING RESULTS MILESTONES

Here’s a timeline of milestones observed in clinical studies. See clinical trial results.

In clinical studies, the majority of people taking SOTYKTU saw improvement in psoriatic arthritis symptoms at 4 months and at 1 year.*

Timeline showing a SOTYKTU® study where patients saw PsA symptom relief at 4 months, with more patients improving by 1 year.

*Based on an improvement score that combined multiple scores for: joint swelling and tenderness, pain, disability, inflammation, and both patient and doctor assessments.

ACR20=American College of Rheumatology 20% improvement criteria.

Your results may vary.

STAYING ON TRACK WITH SOTYKTU

Treatment takes time to work—here are some helpful tips to stay consistent with your every day pill.

Develop a routine

Take SOTYKTU as part of your daily routine or as prescribed by your rheumatologist.
Set yourself a reminder to take your once-daily pill.

Give yourself a reminder

Place a note on your bathroom mirror or an alert on your phone.
Keep your medication in an easily accessible place.

Keep it visible

Leave your medicine in a safe place that’s easy to spot.
Consider utilizing a weekly pill box to keep track of your medication.

Try a pill box

A pill box labeled with days of the week can help you keep track.
Record each dose your take with a calendar.

Record each dose

Use a calendar to check off that you’ve taken SOTYKTU each day.
Bring your medication with you whenever you're traveling.

Bring extra when traveling

If you’ll be traveling, bring extra medication with you in case your trip is unexpectedly extended.

ANSWERS TO COMMON QUESTIONS

Psoriatic arthritis (PsA) is a chronic immune disease and a type of arthritis that can cause pain, swelling, and stiffness in your joints. Psoriatic arthritis can get worse over time, but there are treatments that can help you manage it. Learn more about it here.

Like with any medication, the time it takes to see possible results with SOTYKTU will vary from person to person.

In clinical trials, 54% of people taking SOTYKTU felt noticeable improvement in their psoriatic arthritis symptoms at 4 months, as measured by ACR20, an improvement score that combines multiple scores for: joint swelling and tenderness, pain, disability, inflammation, and both patient and doctor assessments.

Check out the study results for a deeper dive into the data.

If you miss a dose, give your rheumatologist a call and ask what you should do.

As with all prescription medications, some side effects are possible with SOTYKTU and it is important for you to be aware of them. In moderate to severe plaque psoriasis studies, the most common side effects with SOTYKTU were common cold, sore throat, and sinus infection (upper respiratory infections); cold sores (herpes simplex); sores on inner lips, gums, tongue, or roof of the mouth (canker sores); inflamed hair pores (folliculitis); and acne.

Overall the most common side effects reported by people taking SOTYKTU for active psoriatic arthritis were similar to those reported by people taking SOTYKTU for moderate to severe plaque psoriasis. These are not all of the possible side effects of SOTYKTU. 

Talk to your healthcare provider, 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.

For more information on SOTYKTU safety and possible side effects, including the percentage of patients who experienced them in clinical trials, visit Safety & Side Effects.

If you’ve been prescribed SOTYKTU and have commercial insurance, the Co-Pay Assistance Program may be able to offer financial support to help with the out-of-pocket costs for your treatment.

Learn about the Co-Pay Assistance Program. Additional eligibility and terms and conditions apply.

SOTYKTU is provided by a specialty pharmacy—a mail-order pharmacy that carries many specialty medicines (like SOTYKTU) not typically carried by local pharmacies. Refills are delivered directly to your home.

For medical questions, including questions about taking SOTYKTU, contact your healthcare provider.

For questions about insurance coverage, paying for SOTYKTU, and specialty pharmacy delivery, a SOTYKTU Support Coordinator is available by calling 1-855-525-7203 Monday through Friday, 8 AM to 8 PM ET.

GET TO KNOW SOTYKTU

See how SOTYKTU fits into everyday life for people living with psoriatic arthritis.
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Important Facts About
SOTYKTU®
(deucravacitinib)

This is a summary of important information that you need to know about SOTYKTU. Your healthcare provider 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 healthcare provider

Call a healthcare provider 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).

Active psoriatic arthritis in adults.

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 healthcare provider 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 healthcare provider 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 healthcare provider should watch you closely for signs and symptoms of TB during treatment with SOTYKTU.

If you get a serious infection, your healthcare provider may tell you to stop taking SOTYKTU until your infection is controlled.

Call or see a healthcare provider if you notice any symptoms of TB.

Call or see a healthcare provider 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 healthcare provider tells you it is okay.

You may be at higher risk of developing shingles (herpes zoster).

Before starting SOTYKTU, tell your healthcare provider 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 healthcare provider if you have TB or have been in close contact with someone with TB.
    • Hepatitis B or C. Tell your healthcare provider if you have or have had hepatitis B or C.

After you start taking SOTYKTU, call your healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider before starting treatment?

Talk to your healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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 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 healthcare provider, 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 healthcare provider 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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