For US residents only.

For topical, short-term, non-continuous chronic treatment of mild to moderate eczema in people 2 and older without weakened immune systems. Not recommended for use in combination with other biologics, JAK inhibitors, or strong immunosuppressants (ie, cyclosporine).
Mild to Moderate Eczema
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PROVEN RESULTS.  
PROVEN RELIEF.

Through various clinical trials, OPZELURA has been studied and proven to help clear the visible signs of eczema in people ages 2 and up with mild to moderate eczema and a range of skin tones.

OPZELURA was first studied for 8 weeks in two clinical trials of more than 1200 people ages 12 and older. Later, OPZELURA was studied in an 8-week clinical trial of 330 children ages 2-11.

Results may vary. See the results:

 

SKIN CLEARANCE

In clinical studies, MORE THAN HALF OF PATIENTS

achieved clear or almost clear skin at 8 weeks

In patients 2-11: 57% achieved results compared to 11% not using OPZELURA

In patients 12+: 54% achieved results compared to 15% not using OPZELURA. Similar results were seen in another clinical study of patients 12+

AT 1 YEAR OF AS-NEEDED USE

After the 8-week studies ended, patients were given the choice to keep using OPZELURA for up to one year as needed when eczema signs and symptoms returned. This was a less rigorous part of the study where patients and their physicians knew they were using an active treatment, which could have affected the results.

APPROXIMATELY 75% OF 
PATIENTS STILL USING OPZELURA HAD 
CLEAR OR ALMOST CLEAR SKIN
72.3% in patients 2-11
77.8% in patients 12+
On average, patients EXPERIENCED MORE THAN 4 MONTHS OF FLARE-FREE DAYS
Patients 2-11 spent nearly 5 months on average in total number of days without needing treatment.
Patients 12+ spent an average of 4.5 months in total number of days without needing treatment.
Over time, patients NEEDED OPZELURA FOR FEWER BODY AREAS
In patients 2-11, average eczema areas changed from 11.1% to 1.9%
In patients 12+, average eczema areas changed from 9.6% to 1.4%

OPZELURA was applied twice daily for 8 weeks on areas where patients had eczema, including sensitive areas such as the face. OPZELURA was used on affected areas, on up to 20% of body surface area. For the 44-week extension period, OPZELURA was applied as needed, twice daily.

OPZELURA is for use on the skin only. Do not use in your eyes, mouth, or vagina. Stop using OPZELURA when signs and symptoms (eg, itch, rash, and redness) of eczema resolve. For patients 12+, do not use more than one 60 gram tube of OPZELURA per week. For patients 2-11, do not use more than one 60 gram tube of OPZELURA per two weeks. Talk to your healthcare provider if you don't see an improvement within 8 weeks.

Learn about how OPZELURA was studied in children 2-11 years old.
Learn about how OPZELURA was studied in people 12+ years old.
 

REAL OPZELURA RESULTS

The following photos are a range of patients who used OPZELURA for their mild to moderate eczema, before and after treatment. Since life affects everything, there may be other factors influencing the real-world patients’ treatment results. 
Individual results may vary.

Clinical Trial Patients 
at week 8

Clinical Trial Patients 
at week 8

Clinical trial patient

Patient 2 years old with clearer skin, with less eczema after OPZELURA treatment

Back of Knee

Patient 2 years old with irritated skin and eczema patches before OPZELURA treatment

Clinical trial patient

Patient 5 years old with clearer skin, with less eczema after OPZELURA treatment

INSIDE ELBOW

Patient 5 years old with irritated skin and eczema patches before OPZELURA treatment

Clinical trial patient

Patient 15 years old with clearer skin, with less eczema after OPZELURA treatment

Knee

Patient 15 years old with irritated skin and eczema patches before OPZELURA treatment

Clinical trial patient

Patient 64 years old with clearer skin, with less irritation after OPZELURA treatment

Neck

Patient 64 years old before OPZELURA treatment with irritated and inflamed skin

Clinical trial patient

Patient 85 years old with clearer skin, with less eczema after OPZELURA treatment

Back

Patient 85 years old with red, irritated skin and eczema patches before OPZELURA treatment

Actual patient

Patient 64 years old with clearer skin, with less eczema after OPZELURA treatment

Right buttocks

Patient 64 years old with irritated skin and eczema patches before OPZELURA treatment

Actual patient

Patient 67 years old with clearer skin, with less eczema after OPZELURA treatment

Hand

Patient 67 years old with irritated skin and eczema patches before OPZELURA treatment

Actual patient

Patient 69 years old with clearer skin, with less eczema after OPZELURA treatment

Hands

Patient 69 years old with irritated skin and eczema patches before OPZELURA treatment

Actual patient

Patient 75 years old with clearer skin, with less eczema after OPZELURA treatment

Ankle

Patient 75 years old with irritated skin and eczema patches before OPZELURA treatment

Real-World Patients

Actual patient

Patient 64 years old with clearer skin, with less eczema after OPZELURA treatment

Right buttocks

Patient 64 years old with irritated skin and eczema patches before OPZELURA treatment

Actual patient

Patient 67 years old with clearer skin, with less eczema after OPZELURA treatment

Hand

Patient 67 years old with irritated skin and eczema patches before OPZELURA treatment

Actual patient

Patient 69 years old with clearer skin, with less eczema after OPZELURA treatment

Hands

Patient 69 years old with irritated skin and eczema patches before OPZELURA treatment

Actual patient

Patient 75 years old with clearer skin, with less eczema after OPZELURA treatment

Ankle

Patient 75 years old with irritated skin and eczema patches before OPZELURA treatment

OPZELURA was studied in an 8-week double-blind, vehicle-controlled clinical trial. This means that participants received either OPZELURA or just the vehicle—a cream without medication. Participants were not told which they received. 330 children between the ages of 2 and 11 with mild to moderate eczema participated in this trial.

Who participated in the trials?

Gender

54% female, 46% male

Race/ethnicity

  • 55% Caucasian
  • 32% Black/African American
  • 6% Asian

Percentage of body area affected by eczema

3% to 20%. The average affected area was 10.5%.

Severity*

Participants had an eczema severity of 2 (mild) or 3 (moderate) on a scale of 0 to 4 (where 0 represented no eczema and 4 represented severe eczema). 76% of participants had a score of 3 (moderate).

*People with severe eczema were not included in the trial.

OPZELURA was studied in 2 double-blind, vehicle-controlled clinical trials. This means that participants received either OPZELURA or just the vehicle—a cream without medication. Participants were not told which they received. More than 1200 people with mild to moderate eczema participated in these trials for 8 weeks, with 20% of participants ranging in age from 12-17 years old.

Who participated in the trials?

Gender

62% female, 38% male

Race/ethnicity

  • 70% Caucasian
  • 23% Black/African American
  • 4% Asian

Percentage of body area affected by eczema

3% to 20%. The average affected area was 9.8%.

Severity*

Participants had an eczema severity of 2 (mild) or 3 (moderate) on a scale of 0 to 4 (where 0 represented no eczema and 4 represented severe eczema). 75% of participants had a score of 3 (moderate).

*People with severe eczema were not included in the trial.

Were there any side effects in the 8-week clinical trials or with 1 year of as-needed use?

The most common side effects in the 8-week clinical trials observed in at least 1% of people using OPZELURA were common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count or decrease in a type of white blood cell (neutropenia) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea), upper respiratory tract infection, COVID-19, fever, and pain, irritation, discomfort, or itching at the application site.

The most common side effects in ages 2-11 years over 1 year, seen in at least 3% of people using OPZELURA, were upper respiratory tract infection, common cold, COVID-19, stomach flu, ear infection, diarrhea, fever, and vomiting.

The most common side effects in ages 12+ over 1 year, seen in at least 3% of people using OPZELURA, were upper respiratory tract infection, common cold, headache, bronchitis, and influenza.

Serious side effects can also occur. Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA.

FIND SUPPORT WITH YOUR HEALTHCARE PROVIDER

When managing eczema, it’s important to partner with your healthcare provider.

Together, you can discuss treatment goals, determine if OPZELURA is right for you or your child, and track treatment progress. We’ve compiled the Eczema E-Guide*: 7 quick questions that can help you prepare for your next conversation with your provider.

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

Start The Eczema E-Guide
 

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

OPZELURA is a prescription medicine used on the skin (topical) for:

  • short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised adults and children 2 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.

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, which are medicines that affect your immune system and can lower your ability 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 using 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) and major cardiovascular events: Increased risk of death and major cardiovascular events (eg, heart attack or stroke) has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking JAK inhibitors by mouth, especially current or past smokers.

Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. People taking JAK inhibitors by mouth have reported lymphoma and other cancers and are at higher risk of certain cancers including lymphoma and lung cancer, especially if they have ever smoked. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment. Limit the amount of time you spend in the sun, wear protective clothing and use a broad-spectrum sunscreen.

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. DVT and PE have happened more often in people taking JAK inhibitors by mouth who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor.

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

Potential risks from Janus kinase (JAK) inhibition: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides. Low blood sugar in people with diabetes has happened after taking JAK inhibitors by mouth.

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 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. 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. This registry is intended to collect information about the health of you and your baby
  • 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, blood clot, 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
  • swelling, pain, or tenderness in one or both legs
  • 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 or decrease in a type of white blood cell (neutropenia) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), runny nose (rhinorrhea), upper respiratory tract infection, COVID-19, fever, and pain, irritation, discomfort, or itching at the application site.

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.