Pronunciation:

due-krav-a-SYE-ti-nib

Brand Names:

• Sotyktu

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antipsoriatic

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Deucravacitinib is used to treat moderate to severe plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. It is given to patients who may receive other types of treatment, including pills, injection, or phototherapy (light treatment).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of deucravacitinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of deucravacitinib in the elderly. However, this medicine may cause serious infections more often in the elderly, which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer, history of or
• High triglycerides (fat) in the blood or
• Infection, history of or
• Liver disease (eg, hepatitis B or C) or
• Tuberculosis, history of—Use with caution. May make these conditions worse.

• Infection, active or
• Liver disease, severe—Use is not recommended in patients with this condition.

• Tuberculosis, active—Should be treated first before receiving this medicine.

Proper Use of This Medicine:

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with or without food. Swallow the tablet whole. Do not crush, cut, or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For plaque psoriasis:
    • Adults—6 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.

Your body's ability to fight infections may be reduced while you are using deucravacitinib. It is very important that you call your doctor at the first sign of an infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Check with your doctor right away if you have burning or stinging of the skin or painful cold sores or blisters on the lips, nose, eyes, or genitals. These may be symptoms of herpes simplex infection or shingles.

This medicine may cause serious allergic reaction, including angioedema, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.

This medicine may increase your risk of cancer, including lymphoma. Check with your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, or yellow skin and eyes.

This medicine may cause rhabdomyolysis (severe muscle problem). Check with your doctor right away if you have dark-colored urine, fever, muscle cramps, spasms, pain, or stiffness, or unusual tiredness or weakness.

This medicine may increase your risk of developing blood clots (eg, 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. Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area, or trouble breathing.

Do not have any live vaccines (immunizations) while you are being treated with deucravacitinib. Check with your doctor before having any vaccines.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chest tightness

chills

cough

dryness or soreness of the throat

ear congestion

fever

headache

loss of voice

muscle aches

pain or tenderness around eyes and cheekbones

sneezing

sore throat

stuffy or runny nose

swollen glands

trouble breathing

trouble in swallowing

unusual tiredness or weakness

voice changes

Less common

Burning or stinging of skin

painful cold sores or blisters on the lips, nose, eyes, or genitals

Incidence not known

Anxiety

black, tarry stools

chest pain

dizziness or lightheadedness

fainting

general feeling of illness

pain, redness, or swelling in the arm or leg

painful blisters on the trunk of the body

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

weight loss

yellow skin and eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Blemishes on the skin

burning, itching, and pain in the hairy areas, pus at the root of the hair

irritation or soreness of the mouth

pimples

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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