Sotyktu (deucravacitinib) is a prescription medicine that is a once-daily tablet used to treat adults with moderate to severe plaque psoriasis,  that is suitable for systemic therapy or phototherapy.

Sotyktu belongs to a new class of drugs called tyrosine kinase 2 (TYK2) inhibitors that works by blocking a protein called TYK2.

TYK2 is part of the immune system that has a role in inflammation and can cause plaque psoriasis. Blocking TYK2 improves symptoms of psoriasis, by reducing the severity and amount of psoriasis lesions.

What is Sotyktu used to treat?

Sotyktu tablets are used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

Sotyktu tablets became a FDA approved medicine on September 9, 2022.

Sotyktu Enrollment Form.

For more information on Sotyktu prices, coupons, and patient enrollment form (also known as the Sotyktu start form), click here: Sotyktu Patient Assistance Program

Sotyktu may cause serious side effects, including:

Serious allergic reactions. Stop treatment and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

• feel 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. Some people have had serious infections while taking Sotyktu, such as infections of the lungs, including pneumonia and tuberculosis (TB), and COVID-19.

• Your healthcare provider should check you for infections and TB before starting treatment.
• Your healthcare provider may treat you for TB before you begin treatment if you have a history of TB or have active TB.
• Your healthcare provider should watch you closely for signs and symptoms of TB during treatment.
• If you get a serious infection, your healthcare provider may tell you to stop treatment until your infection is controlled.

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 a higher risk of developing shingles (herpes zoster).

Before you start treatment, tell your healthcare provider if you:

• are being treated for an infection
• have had an infection that does not go away or keeps coming back
• have TB or have been in close contact with someone with TB
• have or have had hepatitis B or C
• think you have an infection or have symptoms of an infection such as:
  • fever, sweats, or chills
  • muscle aches
  • weight loss
  • cough
  • shortness of breath
  • blood in your phlegm (mucus)
  • 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

After you start taking Sotyktu, call your healthcare provider right away if you have an infection or have 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

See Sotyktu side effects for more information about side effects.

• Take the Sotyktu tablets exactly as directed by your healthcare provider.
• Take Sotyktu one time every day.
• Take the tablets with or without food.
• Do not crush, cut, or chew the tablets.

Usual Adult Dose for Plaque Psoriasis:

- 6 mg orally once daily.

Use: treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

You should not take Sotyktu if you are allergic to deucravacitinib or any of the other ingredients. See the end of this page for a complete list of ingredients.

Before taking Sotyktu

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• See Important information.
• have liver problems or kidney problems
• have high levels of fat in your blood (triglycerides)
• have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment.
• are pregnant or plan to become pregnant. It is not known if Sotyktu can harm your unborn baby.
  Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
• are breastfeeding or plan to breastfeed. It is not known if Sotyktu passes into your breast milk.

Sotyktu may cause serious side effects, including:

See Important information.

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, and during treatment to check for the following:

• Increased triglycerides. Triglycerides are a type of fat found in your blood. Too much fat in your blood can cause problems with your heart.
• Increased liver enzymes. Liver enzymes are found in your blood and help to tell if your liver is functioning normally. 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 treatment 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 one 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.

The most common side effects 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.