Deucravacitinib is used to treat adults with moderate to severe plaque psoriasis.

Deucravacitinib may also be used for purposes not listed in this medication guide.

Serious infections may occur during treatment with deucravacitinib. Call your doctor right away if you have signs of infection such as: 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.

Deucravacitinib can cause the breakdown of muscle tissue, which 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take deucravacitinib once every day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

You will need medical tests before you start taking deucravacitinib and while taking deucravacitinib.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Plaque Psoriasis:

Recommended dose: 6 mg orally once a day

Comments:
-This drug may be taken with or without food.
-Evaluate patients for latent or active tuberculosis infection prior to treatment initiation.
-Avoid use with live vaccines.
-Use with other immunosuppressants is not recommended.

Use: For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. This drug is not recommended for use in combination with other potent immunosuppressants.

You should not use deucravacitinib if you are allergic to it.

Tell your doctor if you have ever had:

• liver or kidney disease;

• hepatitis B or 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 are being treated for an infection;

• 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.

Tell your doctor if you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Avoid receiving a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Deucravacitinib can cause the breakdown of muscle tissue, which 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.

Also call your doctor at once if you have:

• signs of infection--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.

Common side effects of deucravacitinib may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• cold sores, sores on your gums, tongue or mouth;

• folliculitis (redness or crusting around your hair follicles); or

• acne.

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 FDA at 1-800-FDA-1088.

Other drugs may affect deucravacitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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.