For US residents only.

OPZELURA is a prescription medicine used on the skin (topical) for the treatment of the type of vitiligo called nonsegmental vitiligo in adults and children 12 years of age and older. The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.
Nonsegmental Vitiligo
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Nonsegmental Vitiligo
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A young woman's face with vitiligo, showing depigmentation before treatment with OPZELURA and repigmentation progress at both 8 months and 2 years of treatment with OPZELURA.
Sam was not a clinical trial participant. Results may vary. Results not typical.

Nonsegmental vitiligo is the most common type of vitiligo—where depigmented patches appear on both sides of the body. It’s time you had a proven choice to help restore what’s yours.

In Two 6-month 
CLINICAL STUDIES OF OPZELURA
about one third 
of participants saw
75% improvement 
in a score that measured vitiligo areas on the face

75% improvement to vitiligo areas on the face was achieved at 6 months in 29.9% of patients using OPZELURA in 2 separate studies compared with 7.5% and 12.9% of patients using a non-medicated cream.

 

Explore what repigmentation could look like—with OPZELURA.

 
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OPZELURA is the first 
medicated cream of its kind 
for adults and children 12+ 
with nonsegmental vitiligo

How OPZELURA works

OPZELURA should be applied 
twice daily on up to 10% of 
body surface area (BSA)* 
—even around the eyes†

How to use opzelura

Vitiligo is hardly simple, but 
science can help make 
sense of it

Learn more about vitiligo

*1 handprint = 1% of your body surface area.
†OPZELURA is for use on the skin only. Do not use in the eyes, mouth, or vagina.

Repigmentation: 
see What's possible

Wondering what’s possible with OPZELURA? See what repigmentation looked like for Sam, an actual OPZELURA patient. OPZELURA was studied in two clinical trials through 2 years in participants aged 12 and older with nonsegmental vitiligo on up to 10% of their total body surface area (BSA). Phototherapy was not permitted during the trial. These photos show Sam (not a clinical trial participant) before treatment with OPZELURA, and at about 2 months, 8 months, 12 months, and 2 years of treatment.

Before
treatment
with OPZELURa

A young woman's face with vitiligo, showing depigmentation before treatment with OPZELURA.

Before treatment
with OPZELURa

AT ~2 months
of treatment
with OPZELURA

A young woman's face with vitiligo, showing repigmentation progress at 2 months of treatment with OPZELURA.

AT ~2 months of
treatment with OPZELURA

AT ~8 months
of treatment
with OPZELURA

A young woman's face with vitiligo, showing more repigmentation progress at 8 months of treatment with OPZELURA.

AT ~8 months of
treatment with OPZELURA

AT ~12 months
of treatment
with OPZELURA

A young woman's face with vitiligo, showing more repigmentation progress at 12 months of treatment with OPZELURA.

at ~12 months of
treatment with OPZELURA

AT ~2 years of
treatment
with OPZELURA

A young woman's face with vitiligo, showing more repigmentation progress at 2 years of treatment with OPZELURA.

AT ~2 years of treatment
with OPZELURA

Sam used OPZELURA alone for treatment of vitiligo on her face and neck. Not a clinical trial participant.

Results may vary. Results not typical.

OPZELURA results were studied in some clinical trial patients through 2 years.

SEE PATIENT STORIES

“WORTH IT”

90% of patients who have used OPZELURA for repigmentation agreed that it was worth their time and effort.

An online survey was conducted on behalf of Incyte from March-May 2024, where 105 people with nonsegmental vitiligo who have been using OPZELURA for at least 3 months were asked about their treatment experience.

Limitations: This survey relied on self-reported data, was not confirmed by a medical professional, and can be affected by bias from selection, recall, response styles, and other sources. Opinions may not be representative of the general population.

This survey covered condition and treatment background, disease state, OPZELURA experience, and overall OPZELURA satisfaction.

OPZELURA tube

START A VIRTUAL APPOINTMENT

Skip wait times of in-person visits, and discuss your vitiligo treatment options virtually with a board-certified dermatologist as soon as today.

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OPZELURA Copay Savings Card

Learn about copay savings

ELIGIBLE* PATIENTS WITH COMMERCIAL INSURANCE MAY PAY AS LITTLE AS $0 PER TUBE FOR OPZELURA.

See if you qualify for the OPZELURA Copay Savings Card today.

GET STARTED

*Eligibility required. For use only with commercial prescription insurance. The card may not be used if the patient is enrolled in a government-funded prescription insurance program or if they pay cash for their prescription. Individual out-of-pocket cost may vary. Maximum benefits per tube and per calendar year apply. Must be used for an FDA-approved indication. Additional Terms and Conditions apply.

IMPORTANT SAFETY INFORMATION AND INDICATION
Indication and Usage

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

  • the treatment of a type of vitiligo called nonsegmental vitiligo in adults and children 12 years of age and older

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 nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever.

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.

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