Deucravacitinib

Deucravacitinib (brand name Sotyktu) is used to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy (light therapy) or to treat adults with active psoriatic arthritis. It is a once-daily, oral tyrosine kinase 2 (TYK2) blocker.

Deucravacitinib works by blocking an immune system protein called TYK2, which has a role in inflammation and has been associated with plaque psoriasis and psoriatic arthritis. Blocking TYK2 improves symptoms of psoriasis and psoriatic arthritis.

Deucravacitinib was FDA-approved on September 9, 2022, under the brand name Sotyktu. There is no generic available.

Deucravacitinib is approved to treat adults with:

• Moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy (light therapy)
• Active psoriatic arthritis.

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

Do not take deucravacitinib if you are allergic to deucravacitinib, Sotyktu, or any inactive ingredients in the tablets.

Deucravacitinib is not recommended for people with severe liver disease (Child-Pugh C).

Before you start treatment, tell your healthcare provider about all your medical conditions, including 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 or any other liver problems
• Have kidney problems
• Have high levels of fat (triglycerides) in your blood
• Have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment
• 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
• Have diabetes
• Are pregnant or intending to become pregnant
• Are breastfeeding.

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.

Common side effects

The most common side effects of deucravacitinib include:

• upper respiratory infections such as the common cold, a sore throat, or sinus infections
• cold sores (herpes simplex)
• sores on the inner lips, gums, tongue, or roof of the mouth (canker sores)
• inflamed hair pores (folliculitis)
• acne.

Serious side effects and warnings

Deucravacitinib 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. Deucravacitinib is a medicine that affects your immune system and can lower the ability of your immune system to fight infections and increase your risk of infections. Some people have had serious infections while taking deucravacitinib, 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. Deucravacitinib should not be used in people with an active, serious infection, including localized infections. You should not start taking deucravacitinib 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).
• Changes in certain laboratory test results. Changes in laboratory tests have happened in some people taking deucravacitinib. 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 deucravacitinib is harming your liver.
• Potential risks from Janus kinase (JAK) inhibition. Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor. TYK2 is in the JAK family. It is not known whether taking deucravacitinib has the same risks as taking JAK inhibitors. An increased risk of death (all causes) has occurred 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. Deucravacitinib is not for use in people with RA. Low blood sugar (hypoglycemia) in people with diabetes has happened after taking JAK inhibitors. Tell your healthcare provider if you have any problems with low blood sugar.
• Cancer. Certain kinds of cancer, including lymphoma, have been reported in people taking deucravacitinib. Tell your healthcare provider if you have ever had any type of cancer.
• Muscle problems (rhabdomyolysis). Deucravacitinib can cause muscle problems that can be severe. Treatment with deucravacitinib 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 deucravacitinib. Your healthcare provider may tell you to stop taking deucravacitinib 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.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Adult Dose of Deucravacitinib for Plaque Psoriasis and Psoriatic Arthritis

• 6 mg orally once daily.

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

Drug interaction studies have not identified any clinically significant interactions with deucravacitinib to date. See the product information for an updated list of interactions.

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

Store at room temperature between 68°F and 77°F (20°C and 25°C).

Keep all medicines out of the reach of children and pets.

Deucravacitinib is only available under the brand name Sotyktu.

Sotyktu 6 mg tablets

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

Deucravacitinib is distributed under the brand name Sotyktu by Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA.