Deucravacitinib (due-krav-a-SYE-ti-nib)

Treats plaque psoriasis.

Brand Name(s):

Sotyktu

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole. Do not crush, cut, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Do not have any live vaccines during treatment with this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease (including hepatitis B or C), or a history of cancer or infection (including tuberculosis). Tell your doctor if you have a current infection or an infection that keeps coming back.
• This medicine may cause the following problems:
  • Increased risk for serious infections, including herpes infection or shingles
  • Increased risk of certain cancers, including lymphoma
  • Rhabdomyolysis (severe muscle problem)
  • Increased risk of blood clots (including thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, coughing up blood, trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Muscle pain, tenderness, or weakness
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Painful cold sores or blisters on lips, nose, eyes, or genitals
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Burning, itching, or pain in hairy areas, pus at root of hair
• Pimples
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088