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For the short-term, non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) not well controlled on topical therapies in adults and children 12 and older without weakened immune systems or when those therapies are not recommended.
Mild to Moderate Eczema
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Mild to Moderate Eczema (Atopic Dermatitis)
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what is eczema?

Eczema is a term used to describe conditions that cause the skin to become itchy, inflamed, or have a rash-like appearance. Your healthcare provider may sometimes refer to your eczema as “atopic dermatitis”. It’s a chronic inflammatory condition that’s caused by an imbalance in part of your immune system. This leads to inflammation below and above the surface of the skin, which causes the symptoms of eczema—something you are likely familiar with.

ECZEMA SYMPTOMS 
CAN INCLUDE:

  • Itch
  • Dry skin
  • Inflamed skin that may appear red, darker brown, purple, or ashen gray
  • Rough or scaly patches of skin

common body 
parts affected:

Eczema commonly appears in areas where the skin folds and creases, such as the hands and wrists, neck, inner elbows, ankles, backs of knees, around the eyes, and face.

Hands and 
wrists

Neck

Inner 
elbows

Ankles

Back of 
knees

Around 
the eyes

Face

Caring for your loved one with mild to moderate eczema

Caring for your loved one with mild to moderate 
eczema

 

It’s important to understand how eczema impacts your loved one. Be sure to complete the Eczema E-Guide* 
with them before their next appointment.

*Please note the Eczema E-Guide is not a diagnostic tool used to measure eczema severity or burden. 
Follow guidance from your healthcare provider.

BEGIN THE ECZEMA E-GUIDE
 

So, what causes eczema?

We learned that beneath the surface of the skin, eczema can occur when part of the immune system is imbalanced, which causes too much inflammation in the body. But there are other factors that may contribute to eczema symptoms and flare-ups.

ECZEMA TRIGGERS

While everyone’s experience with eczema is different, there are some common triggers that can cause eczema symptoms:

Irritants 
(ie, soaps and cleaners, 
fragrances, fabrics)

Irritants (ie, soaps 
and cleaners, 
fragrances, fabrics)

Cold and 
dry weather

Stress

Food 
Allergies

If you find that any of these triggers worsen your symptoms, consider avoiding them when you can.

RACE AND ETHNICITY

Some racial and ethnic groups are more likely to develop eczema. Studies have shown that eczema is more prevalent in Black children compared to other races and ethnicities.

genetics

Studies have shown that the risk of developing eczema as a child is two to three times higher when one parent has the condition. Researchers have also found possible correlations between eczema and several different genes. People living with eczema also commonly develop food and seasonal allergies, hay fever, and asthma.

Image of the itch-scratch cycle
Learn how OPZELURA can help

the itch-scratch cycle

Eczema is caused by inflammation beneath the skin, resulting in some major itching. It’s called the itch-scratch cycle—when you scratch the itch, it causes more inflammation and, therefore, more rash, itching, and scratching. This cycle often repeats and may worsen without treatment.

Learn how OPZELURA can help
Enlarge Image
 

REIMAGINE HOW TO TREAT
MILD TO MODERATE ECZEMA

OPZELURA is a one-of-a-kind, 
JAK inhibitor cream for mild to moderate 
eczema. Learn how it could help you.

Get to Know Opzelura

REACH OUT TO YOUR
HEALTHCARE PROVIDER

Being open and honest with a doctor about your eczema can help them create a treatment plan that works for you.

Discuss Opzelura
 
IMPORTANT SAFETY INFORMATION AND INDICATION
IMPORTANT SAFETY INFORMATION AND INDICATION
Indication and Usage

OPZELURA is a prescription medicine used on the skin (topical) for the short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised adults and children 12 years of age and older whose disease is not well controlled with topical prescription therapies or when those therapies are not recommended.

The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.

It is not known if OPZELURA is safe and effective in children less than 12 years of age with atopic dermatitis.

Important Safety Information

OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina.

OPZELURA may cause serious side effects, including:

Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA.

OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA 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) while using OPZELURA.

Increased risk of death due to any reason (all causes): Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth.

Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen.

Increased risk of major cardiovascular events: Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers.

Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth.

Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen.

Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides.

Before starting OPZELURA, tell your healthcare provider if you:

  • have an infection, are being treated for one, or have had an infection that does not go away or keeps coming back
  • have diabetes, chronic lung disease, HIV, or a weak immune system
  • have TB or have been in close contact with someone with TB
  • have had shingles (herpes zoster)
  • have or have had hepatitis B or C
  • live, have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
  • think you have an infection or have symptoms of an infection such as: fever, sweating, or chills, muscle aches, cough or shortness of breath, blood in your phlegm, weight loss, warm, red, or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than usual, feeling very tired.
  • have ever had any type of cancer, or are a current or past smoker
  • have had a heart attack, other heart problems, or a stroke
  • have had blood clots in the veins of your legs or lungs in the past
  • have high cholesterol or triglycerides
  • have or have had low white or red blood cell counts
  • are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463 or www.opzelura.pregnancy.incyte.com.
  • are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose.

After starting OPZELURA:

  • Call your healthcare provider right away if you have any symptoms of an infection. OPZELURA can make you more likely to get infections or make worse any infections that you have.
  • Get emergency help right away if you have any symptoms of a heart attack or stroke while using OPZELURA, including:
  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech
  • Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OPZELURA, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, or shortness of breath or difficulty breathing.
  • Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as: unusual bleeding, bruising, tiredness, shortness of breath, or fever.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of OPZELURA in people treated for atopic dermatitis include: common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea).

These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.

Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA.