【Drug Name】

Name:Deucravacitinib Tablets

Product Name: DUVACIDX

【Specification】6mg

【Indications】

DUVACIDX is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit

from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

It is not known if DUVACIDX is safe and effective in children under 18 years of age.

【Recommended Dosage】

• Take DUVACIDX exactly as your healthcare provider tells you to take it.

• Take DUVACIDX 1 time every day.

• Take DUVACIDX with or without food.

• Do not crush, cut, or chew the DUVACIDX tablets.

【Side Effects】

• See “What is the most important information I should know about DUVACIDX?”

• Changes in certain laboratory test results. Changes in laboratory tests have happened in some people taking

DUVACIDX. Your healthcare provider may do blood tests before you start taking DUVACIDX and during treatment

with DUVACIDX to check for the following:

• Increased triglycerides.

Triglycerides are a type of fat found in your blood. Too much fat in y

our blood can

cause problems with your heart.

• Increased liver enzymes.

Liver enzymes are found in your blood and help to tell if your liver is functioning normally. If your liver enzymes increase too much, your healthcare provider may need to do additional tests on your liver and may tell you to stop taking DUVACIDX if they think that DUVACIDX is harming your liver.

• Potential risks from Janus kinase (JAK) inhibition. DUVACIDX is a tyrosine kinase 2 (TYK2) inhibitor. TYK2

is in the JAK family . It is not known whether taking DUVACIDX has the same risks as taking JAK inhibitors.

Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least 1

heart disease (cardiovascular) risk factor who were taking a JAK inhibitor used to treat rheumatoid arthritis (RA)

compared to people taking another medicine in a class of medicines called TNF blockers. DUVACIDX is not for

use in people with RA.

The most common side effects of DUVACIDX include:

• common cold, sore throat, and sinus infection(upper respiratory infections)               • cold sores (herpes simplex)

• sores on inner lips, gums, tongue, or roof of the mouth (canker sores)                       • inflamed hair pores (folliculitis)

• acne

These are not all of the possible side effects of DUVACIDX.

Call your doctor for medical advice about side effects.

• Serious allergic reactions. Stop taking DUVACIDX and get emergency medical help right away if you develop

any of the following symptoms of a serious allergic reaction:

• feel faint                                    • swelling of your face, eyelids, lips, mouth,

•   tongue, or throat                       • trouble breathing or throat tightness

• chest tightness                          • skin rash, hives

• Infections. DUVACIDX is a medicine that affects your immune system. DUVACIDX can lower the ability of your

immune system to fight infections and can increase your risk of infections. Some people have had serious

infections while taking DUVACIDX, such as infections of the lungs, including pneumonia and tuberculosis (TB),

and COVID-19.

• Your healthcare provider should check you for infections and TB before starting treatment with DUVACIDX.

• Your healthcare provider may treat you for TB before you begin treatment with DUVACIDX if you have a history of TB or have active TB.

• Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with DUVACIDX.

• If you get a serious infection, your healthcare provider may tell you to stop taking DUVACIDX until your

infection is controlled.

DUVACIDX should not be used in people with an active, serious infection, including localized infections. You should

not start taking DUVACIDX if you have any kind of infection unless your healthcare provider tells you it is okay.

You may be at a higher risk of developing shingles (herpes zoster).

Before starting DUVACIDX, tell your healthcare provider if you:

• are being treated for an infection                                                             • have had an infection that does not go away or keeps coming back

• have TB or have been in close contact with someone with TB                • have or have had hepatitis B or C

• think you have an infection or have symptoms of an infection such as:

§ fever, sweats, or chills               § muscle aches                       § weight loss                 § cough

§ shortness of breath                   § blood in your phlegm (mucus)

§ warm, red, or painful skin or sores on your body different from your psoriasis                   § diarrhea or stomach pain

§ burning when you urinate or urinating more often than normal                                           § feeling very tired

After you start taking DUVACIDX, call your healthcare provider right away if you have an infection or have

symptoms of an infection.

DUVACIDX can make you more likely to get infections or make any infections you have worse.

• Cancer. Certain kinds of cancer including lymphoma have been reported in people taking DUVACIDX.

• Tell your healthcare provider if you have ever had any type of cancer.

• Muscle problems (rhabdomyolysis). DUVACIDX can cause muscle problems that can be severe. Treatment

with DUVACIDX may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can

be a sign of muscle damage. Increased CPK is common in people taking DUVACIDX. Your healthcare provider

may tell you to stop taking DUVACIDX if the amount of CPK in your blood gets too high or if you have signs and

symptoms of severe muscle problems. Tell your healthcare provider right away if you have any of these signs or

symptoms of severe muscle problems:

• unexplained muscle pain, tenderness, or weakness           • feeling very tired

• fever                                                                                     • dark-colored urine

【Storage】

Store DUVACIDX at room temperature between 68°F to 86°F (20°C to 30°C).

Keep DUVACIDX and all medicines out of the reach of children.