Deucravacitinib

Deucravacitinib is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults 18 years of age or older whose psoriasis is too severe to be treated by topical medications alone. Deucravacitinib should not be taken with other medications that suppress the immune system. Deucravacitinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cells to multiply.

Deucravacitinib comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take deucravacitinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take deucravacitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Deucravacitinib controls psoriasis but does not cure it. Continue to take deucravacitinib even if you feel well. Do not stop taking deucravacitinib without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking deucravacitinib,

• tell your doctor and pharmacist if you are allergic to deucravacitinib, any other medications, or any of the ingredients in deucravacitinib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking deucravacitinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had liver disease, elevated triglycerides, or cancer.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking deucravacitinib, call your doctor.
• check with your doctor to see if you need to receive any vaccinations. It is important to have all vaccines appropriate for your age before beginning your treatment with deucravacitinib. Also tell your doctor if you have recently received any vaccinations. Do not have any vaccinations during your treatment without talking to your doctor.
• you should know that deucravacitinib may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get an infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with deucravacitinib, call your doctor immediately: fever, sweats, or chills, muscle aches, shortness of breath, cough, warm, red, or painful skin or sores on your body, diarrhea, stomach pain, frequent, urgent, or painful urination, or other signs of infection.
• you should know that using deucravacitinib increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using deucravacitnib. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Deucravacitinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• runny nose, congestion, or sore throat
• sore on mouth, lips, gums, tongue or roof of mouth
• acne
• red, swollen, painful or itchy bumps around hair follicles

Some side effects can be serious. If you experience any of these symptoms, stop taking deucravacitinib and call your doctor immediately or get emergency medical treatment:

• swelling of face, eyelids, lips, mouth, tongue or throat; trouble breathing; throat or chest tightness; feeling faint
• skin rash or hives
• dark-colored urine; unexplained muscle pain, weakness or tiredness; fever or extreme fatigue
• yellowing of skin or eyes; abdominal pain

Deucravacitinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to deucravacitinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Sotyktu^®