For US residents only.

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.
Nonsegmental Vitiligo
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Nonsegmental Vitiligo
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PROVEN TO HELP RESTORE SOME OF YOUR PIGMENT

Through a series of periods spanning 6 months, 1 year, and 2 years, OPZELURA was proven to help restore the skin's color on your face over time. Individual results may vary.

Clinical Study Timelines

6 months
Two six-month studies included 674 participants aged 12 and older. 450 patients used OPZELURA, while the remaining 224 used a non-medicated cream.
1 year
After the first 6 months, all participants—including those who had previously used the non-medicated cream—could use OPZELURA for the next 6 months. This was a less robust part of the study that 580 of the original 674 participants entered.
2 years
After the study's first year, 342 participants who hadn't reached near complete (>90%) improvement to vitiligo areas on the face could keep using OPZELURA for yet another year. This was an even less robust study, focused on those whose skin had shown a lower tendency to repigment.

The descriptors used below are drawn directly from the study itself. They do not reflect the diverse range of terms individuals may use to identify their gender, race, or skin tone. This data represents those who participated at the start of the trials, and may not reflect the sample that remained at 1 or 2 years.

Gender

53% of participants were female and 47% were male.

Percentage of body area affected by vitiligo

At baseline, subjects on average had vitiligo affecting 1% of their facial area and 7.4% of their total body.

Race

5% of participants were Black/African American, 4% were Asian, and 82% were White.

Skin tone

Participants represented a range of tones across the Fitzpatrick scale of skin types.

The Fitzpatrick scale of skin types, including pale white, fair white, medium white, light brown, brown, and black
The Fitzpatrick scale of skin types, including pale white, fair white, medium white, light brown, brown, and black

Time since diagnosis

An average of 15 years had passed since diagnosis of nonsegmental vitiligo.

 
AT 6 MONTHS
 
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.

AT 1 YEAR
 
About
half
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 1 year in 51% of patients out of 356 who continued using OPZELURA in a less-robust extension.

AT 2 YEARS
Among patients who had not yet reached near complete repigmentation to the face
 
TWO THIRDS
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 2 years in 66.1% of patients out of 177 who had not reached complete or almost complete facial repigmentation after using OPZELURA for 1 year and who continued to use OPZELURA for an additional year in an even less-robust extension.

MORE FINDINGS FROM CLINICAL STUDIES:

MORE FINDINGS FROM CLINICAL STUDIES:

About half of participants saw 50% improvement in a score that measured vitiligo areas on the face after 6 months.

Specifically, across two 6-month studies, a similar proportion (51.5% and 51.4%) of those using OPZELURA achieved a 50% improvement to vitiligo areas on the face compared with 17.2% and 23.4%, respectively, of those using a non-medicated cream.

About one in six participants saw
90%
improvement
IN A SCORE
THAT MEASURED
VITILIGO
Areas
on the
Face

Specifically, across two 6-month studies, a similar proportion (15.5% and 15.4%) of those using OPZELURA achieved a 90% improvement to vitiligo areas on the face compared with 2.2% and 1.9%, respectively, of those using a non-medicated cream.

Some participants saw 50% improvement in a score that measured vitiligo areas in the total body (including the face).

Across two 6-month studies, a similar proportion (20.6% and 26.1%) of those using OPZELURA achieved a 50% improvement to vitiligo areas in the total body (including the face) compared with 4.9% and 11.3% of those using a non-medicated cream.

REPIGMENTATION TAKES TIME

The following photos show actual clinical trial participants before treatment with OPZELURA, after 3 months of treatment, and at 6 months of treatment. Repigmentation may continue beyond 6 months.

Before treatment
with OPZELURa

A young woman's face with depigmentation from her vitiligo before treatment with OPZELURA.

Before treatment with
OPZELURa

After 3 months of
treatment with OPZELURA

A young woman's face showing some repigmentation progress after 3 months of treatment.

After 3 months of
treatment with OPZELURA

At 6 months of
treatment with OPZELURA

A young woman's face showing additional repigmentation after 6 months of treatment.

At 6 months of
treatment with OPZELURA

A man's face showing depigmentation from his vitiligo before treatment with OPZELURA.

Before treatment with
OPZELURa

A man's face showing progress with repigmentation after 3 months of treatment.

After 3 months of
treatment with OPZELURA

A man's face showing additional repigmentation after 6 months of treatment.

At 6 months of
treatment with OPZELURA

Areas where the hair follicles are sparse, absent or have turned white may not repigment.

Actual clinical trial patients. Individual results may vary. Results not typical.

POSSIBILITIES BEYOND THE FACE

OPZELURA was tested on the face, but also across the entire body. These photos show an actual clinical trial participant's results and are not typical. Areas of the body with a lower concentration of hair follicles may repigment more slowly than others.

Before treatment 
with OPZELURa

A vitiligo patient showing depigmentation across their elbow and forearm before treatment with OPZELURA.
Elbow

Before treatment with
OPZELURa

After 3 months of 
treatment with OPZELURA

A patient's elbow and forearm showing repigmentation progress after 3 months of treatment.

After 3 months of
treatment with OPZELURA

At 6 months of 
treatment with OPZELURA

A patient's elbow and forearm showing more repigmentation progress after 6 months of treatment.

At 6 months of
treatment with OPZELURA

A patient with vitiligo's foot showing areas of depigmentation before treatment with OPZELURA.
Foot

Before treatment with
OPZELURa

A patient's foot showing some repigmentation progress after 3 months of treatment.

After 3 months of
treatment with OPZELURA

A patient's foot showing more repigmentation progress after 6 months of treatment.

At 6 months of
treatment with OPZELURA

Areas where the hair follicles are sparse, absent or have turned white may not repigment.

Actual clinical trial patients. Individual results may vary. Results not typical.

SEE SAM'S RESULTS WITH OPZELURA 

Sam, an actual OPZELURA patient, shared these photos to show the results she’s seen with OPZELURA. These photos show Sam (not a clinical trial participant) before treatment with OPZELURA, and at about 2 months, 8 months, 10 months, and 12 months of treatment.

SELECT A VIEW (PRE-TREATMENT) TO SEE SAM'S RESULTS 

Front View

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

Before Treatment 
with OPZELURA

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

AT ~2 Months of 
Treatment with OPZELURA

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

AT ~8 Months of 
Treatment with OPZELURA

A young woman with vitiligo's face, showing more repigmentation progress at 10 months of treatment.

AT ~10 Months of 
Treatment with OPZELURA

A young woman with vitiligo's face, showing results: 85% facial repigmentation at 12 months of treatment.

AT ~12 Months of 
Treatment with OPZELURA

Right View

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

Before Treatment 
with OPZELURA

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

AT ~2 Months of 
Treatment with OPZELURA

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

AT ~8 Months of 
Treatment with OPZELURA

A young woman with vitiligo's face, showing more repigmentation progress at 10 months of treatment.

AT ~10 Months of 
Treatment with OPZELURA

A young woman with vitiligo's face, showing results: 85% facial repigmentation at 12 months of treatment.

AT ~12 Months of 
Treatment with OPZELURA

left View

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

Before Treatment 
with OPZELURA

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

AT ~2 Months of 
Treatment with OPZELURA

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

AT ~8 Months of 
Treatment with OPZELURA

A young woman with vitiligo's face, showing more repigmentation progress at 10 months of treatment.

AT ~10 Months of 
Treatment with OPZELURA

A young woman with vitiligo's face, showing results: 85% facial repigmentation at 12 months of treatment.

AT ~12 Months of 
Treatment with OPZELURA

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

Individual results may vary. Results not typical. 

LONG-TERM SAFETY RESULTS

The safety of OPZELURA  
was assessed for up to 2 years.

SIDE EFFECTS AT TWO YEARS WERE CONSISTENT WITH WHAT WAS OBSERVED IN PATIENTS WHO USED OPZELURA FOR SIX MONTHS AND UP TO ONE YEAR.

At six months, the most common side effects (occurring in 1% or more of patients) observed in patients who used OPZELURA were: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever. At two years, side effects were consistent with what was observed in those who used OPZELURA for six months and up to one year. Among these two-year patients, any adverse effects that emerged during their treatment were mild to moderate. One patient (0.3% of participants) experienced a side effect that caused them to stop using OPZELURA.

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 read the Full Prescribing Information, including Boxed Warning, and Medication Guide.

 
 

COPAY SAVINGS CARD

Eligible patients can receive an 
OPZELURA copay savings card.

See if you qualify

REIMAGINE THE DISCUSSION WITH
your healthcare provider

We're here to help as you talk with your 
healthcare provider about whether 
OPZELURA may be right for you.

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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.

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

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.
  • 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 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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