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.
 

Opzelura Results

PROVEN TO HELP RESTORE SOME OF YOUR SKIN COLOR

OPZELURA was studied in two clinical trials for 6 months. Participants included 674 people (450 receiving OPZELURA, 224 receiving a cream with no active ingredient) aged 12 and older, who had received a diagnosis of nonsegmental vitiligo about 15 years prior, on average. Studies of OPZELURA included males and females, across a range of skin tones and races. Patients had vitiligo affecting up to 10% of their total body surface area (BSA). Phototherapy was not permitted during the trial. In clinical trials, OPZELURA was proven to help restore the skin's color over time. Individual results may vary.

 

IN TWO 6-MONTH
clinical studies…

About one third OF participants saw
75%
improvement
in a score
that measured
vitiligo
areas on
the face
75%
improvement
in a score that measured
vitiligo
areas on the face

SPECIFICALLY, ACROSS TWO 6-MONTH STUDIES, THE SAME PROPORTION (29.9%) OF THOSE
USING OPZELURA ACHIEVED A 75% IMPROVEMENT TO VITILIGO AREAS ON THE FACE COMPARED
WITH 7.5% AND 12.9%, RESPECTIVELY, OF THOSE USING A NON-MEDICATED CREAM.

 

About one sixth OF participants saw
90%
improvement
in a score
that measured
vitiligo
areas on
the face
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.

 

MORE FINDINGS FROM THE TWO OPZELURA 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.

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.

Icon Calender

REPIGMENTATION MAY CONTINUE BEYOND 6 MONTHS

In both clinical studies, after the first 6 months, participants in both groups (OPZELURA and non-medicated cream) could choose to apply OPZELURA for the next 6 months to see how well their pigment returned over the long term. Ask your healthcare provider about the long-term results of OPZELURA.

REAL-LIFE REPIGMENTATION

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

Female patient's face before treatment with OPZELURA

Before treatment
with OPZELURa

After 3 months of
treatment with OPZELURA

Female patient's face after 3 months of treatment with OPZELURA

After 3 months of
treatment with OPZELURA

At 6 months of
treatment with OPZELURA

Female patient's face after 6 months of treatment with OPZELURA

At 6 months of
treatment with OPZELURA

Male patient's face before treatment with OPZELURA

Before treatment
with OPZELURa

Male patient's face after 3 months of treatment with OPZELURA

After 3 months of
treatment with OPZELURA

Male patient's face after 6 months of treatment with OPZELURA

At 6 months of
treatment with OPZELURA

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

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. Not all vitiligo areas included in the total body measurement are represented in the photos below.

Before treatment
with OPZELURa

Patient's elbow before treatment with OPZELURA
Elbow

Before treatment
with OPZELURa

After 3 months of
treatment with OPZELURA

Patient's elbow after 3 months of treatment with OPZELURA

After 3 months of
treatment with OPZELURA

At 6 months of
treatment with OPZELURA

Patient's elbow after 6 months of treatment with OPZELURA

At 6 months of
treatment with OPZELURA

Patient's foot before treatment with OPZELURA
Foot

Before treatment
with OPZELURa

Patient's foot after 3 months of treatment with OPZELURA

After 3 months of
treatment with OPZELURA

Patient's foot after 6 months of treatment with OPZELURA

At 6 months of
treatment with OPZELURA

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

Individual results may vary. Results not typical.

OPZELURA was studied in 2 randomized, vehicle-controlled phase 3 studies. This means that participants received either OPZELURA or just the vehicle—a cream with no active ingredients. Participants were not told which they received. More than 650 people with nonsegmental vitiligo ages 12 and older participated in these trials for 6 months. A portion of the participants continued in an extension trial for an additional 6 months. Subjects had depigmented areas affecting up to 10% of the total body surface area (facial and nonfacial, including hands, feet, upper and lower extremities, and trunk body areas). Below are the races, skin tones, gender, and disease durations of the patients that were studied.

Who participated in the trials?

Gender:

53% female, 47% male

Race:

82% White,
5% Black/African American,
4% Asian

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.

Time since diagnosis:

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

Skin tone:

Participants represented a range of tones across the Fitzpatrick scale of skin types, including pale white (2%), fair white (30%), medium white (40%), light brown (19%), brown (7%), and black (2%).

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

Most common side effect

Acne at the site of application was the most common side effect of OPZELURA. 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

A fresh 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.