Deucravacitinib

Deucravacitinib is used to treat plaque psoriasis (a condition in which red, scaly patches form on some areas of the body) and psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin). Deucravacitinib is in a class of medications called kinase inhibitors. It works by decreasing the activity of the immune system.

Deucravacitinib comes as a tablet to take by mouth. It is taken with or without food once a day. Take deucravacitinib at around the same time every day.

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.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

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

Before taking deucravacitinib,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• 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 or kidney disease, elevated triglycerides (a type of fat in your blood), rheumatoid arthritis (a condition in which the body attacks its own joints causing pain, swelling, and loss of function), 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.
• do not have any vaccinations during your treatment without talking to your doctor. 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.
• 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. Also tell your doctor if you have or have ever had hepatitis B or hepatitis C (viral infections that affect the liver), or herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past). 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:

• rash; hives; swelling of face, eyelids, lips, mouth, tongue or throat; trouble breathing; throat or chest tightness; or feeling faint
• dark-colored urine; unexplained muscle pain, tenderness, or weakness; fever; or extreme tiredness
• yellowing of skin or eyes,pain in the upper right stomach, nausea, vomiting, or loss of appetite

Deucravacitinib may increase the risk that you will develop a lymphoma (cancer that begins in the cells that fight infection) or other types of cancers. Talk to your doctor about the risks of taking this medication.

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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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