U.S. Full Prescribing Information

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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.

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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 (deucravacitinib) 6mg once-daily pill for patients living within moderate to severe plaque psoriasis.

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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