Pronunciation: soh-tik-too
Generic name: deucravacitinib
Dosage form: tablets (6mg)
Drug class: Multikinase inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Sep 25, 2024.

What is Sotyktu?

Sotyktu (deucravacitinib) is used to treat moderate to severe plaque psoriasis to help improve scaling and redness and reduce thickened areas on the skin and scalp, with some patients achieving clear or almost clear skin and scalp. Sotyktu is a once-daily tablet that works by blocking a protein called tyrosine kinase 2 (TYK2); this reduces the inflammation and immune pathways responsible for plaque psoriasis. Sotyktu is a tyrosine kinase 2 (TYK2) inhibitor. 

Plaque psoriasis is a chronic autoimmune skin condition that has itchy and painful patches of skin that are thickened, red, and typically covered by silvery-white scales. One of the causes of plaque psoriasis involves a protein called tyrosine kinase 2 (TYK2), which works with proteins (IL-23 and IL-17) in your immune system to cause the formation of plaque psoriasis.  Sotyktu works by blocking TYK2, which means there is less IL-23 and IL-17, which helps clear up psoriasis plaques on the skin and scalp

In a clinical trial, 58% of Sotyktu patients had a 75% improvement in their psoriasis score after 16 weeks, and 70% of patients had their scalp psoriasis clear or almost clear (clinical trial PSO-1 NCT03624127). Sotyktu belongs to a new class of drugs called tyrosine kinase 2 (TYK2) inhibitors, which work by blocking a protein called TYK2.

Sotyktu FDA approval was received on September 9, 2022, 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 side effects

Common Sotyktu Side Effects

The common Sotyktu side effects are acne, cold symptoms (stuffy nose, sneezing, sore throat), cold sores, sores on your gums, tongue, or mouth, hair follicle infection, or inflammation (folliculitis). These side effects occurred in 1% or more of patients in clinical trials.

Serious Sotyktu Side Effects

Sotyktu can cause serious side effects, including:

Rhabdomyolysis. The breakdown of muscle tissue  (rhabdomyolysis) can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.

Infection. Call your doctor at once if you have signs of infection including fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

Allergic reactions: Get emergency medical help if you have signs of an allergic reaction, including hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.

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 increased triglycerides and increased liver enzymes.

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 rheumatoid arthritis.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Infections

This medicine affects your immune system and can make you more likely to get infections or worsen any infections you may have. Some people have had serious infections while taking Sotyktu, such as infections of the lungs, including pneumonia, 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.

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

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

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.

Before taking this medication

You should not use this medicine if you are allergic to the active ingredient deucravacitinib, or any inactive ingredients.

Tell your doctor if you have ever had:

• ​​liver or kidney disease
• hepatitis B or heptatitis C
• high blood levels of fat (triglycerides)
• any type of cancer
• tuberculosis or have been exposed to tuberculosis
• if you have an infection that keeps returning or does not go away
• If you think you have an infection, are being treated for 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
• if you have recently received or are scheduled to receive a vaccine; or
• if you have high blood pressure, high cholesterol, diabetes, menopause (women), family history of coronary artery disease, being overweight, or being over 50, or if you smoke.

Sotyktu  is not recommended for use in combination with other potent immunosuppressants.

Pregnancy

It is not known if deucravacitinib can harm your unborn baby. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.

Breastfeeding

It is not known if deucravacitinib passes into breast milk.

How should I take this medicine?

Take the Sotyktu tablet once daily with or without food. Do not crush, cut, or chew the tablets.

Take the Sotyktu tablets exactly as directed by your healthcare provider.

Sotyktu Dosing information

Usual Adult Sotyktu Dose for Plaque Psoriasis: 6 mg tablet orally once daily.

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

What other drugs will affect this medicine?

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.

Sotytku is not recommended for use in combination with other potent immunosuppressants.

Storage

• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep all medicines out of the reach of children and pets.

Sotyktu Ingredients

Sotyktu Active ingredient: deucravacitinib.
Sotyktu Inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose and silicon dioxide.
Film coating Opadry® II Pink: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red and yellow.

Sotyktu Company

Sotyktu Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA

Popular FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer