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OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

OPZELURA healthcare professionals vitiligo homepage

Nonsegmental Vitiligo

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Patient Photos

Visible Results1

A person showing symptoms of nonsegmental vitiligo A person showing symptoms of nonsegmental vitiligo
F-VASI75
F-VASI90
F-VASI50
T-VASI75
T-VASI50

PATIENTS WHO ACHIEVED F-VASI75 AT WEEKS 24, 52, and 104

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view their results

 
 

A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION MET THE PRIMARY ENDPOINT OF F-VASI75 AT WEEK 241

  • Age: 46
  • Sex: Female
  • Fitzpatrick Skin Type: VI
  • Duration of Disease: 37.9 Years (since initial diagnosis)
  • Duration
    of Disease:
    37.9 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 1.5

WEEK 12
F-VASI Score: 0.25

WEEK 24
F-VASI Score: 0.3
80% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.3
80% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION MET THE PRIMARY ENDPOINT OF F-VASI75 AT WEEK 241

  • Age: 46
  • Sex: Male
  • Fitzpatrick Skin Type: II
  • Duration of Disease: 1.4 Years (since initial diagnosis)
  • Duration
    of Disease:
    1.4 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 1.4

WEEK 12
F-VASI Score: 1.16

WEEK 24
F-VASI Score: 0.15
89% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.01
99% IMPROVEMENT
FROM BASELINE.

Polarized images. Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION ACHIEVED F-VASI75 AT WEEK 521

  • Age: 44
  • Sex: Male
  • Fitzpatrick Skin Type: III
  • Duration of Disease: 10.6 Years (since initial diagnosis)
  • Duration
    of Disease:
    10.6 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 2.0

WEEK 12
F-VASI Score: 1.8

WEEK 24
F-VASI Score: 0.56
72% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.21
90% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION ACHIEVED F-VASI75 AT WEEK 521

  • Age: 56
  • Sex: Male
  • Fitzpatrick Skin Type: III
  • Duration of Disease: 11.3 Years (since initial diagnosis)
  • Duration
    of Disease:
    11.3 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 0.59

WEEK 12
F-VASI Score: 0.57

WEEK 24
F-VASI Score: 0.33
44% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.13
78% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION ACHIEVED F-VASI75 AT WEEK 521

  • Age: 56
  • Sex: Male
  • Fitzpatrick Skin Type: III
  • Duration of Disease: 7.4 Years (since initial diagnosis)
  • Duration 
    of Disease:
    7.4 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 2.28

WEEK 12
F-VASI Score: 1.52

WEEK 24
F-VASI Score: 1.28
44% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.4
82% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION ACHIEVED F-VASI75 AT WEEK 1041

  • Age: 21
  • Sex: Male
  • Fitzpatrick Skin Type: III
  • Duration of Disease: 19.9 Years (since initial diagnosis)
  • Duration        
    of Disease:
    19.9 years        
    (since initial diagnosis)

WEEK 0
F-VASI Score: 0.9

WEEK 24
F-VASI Score: 0.87
3% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.58 
36% IMPROVEMENT
FROM BASELINE.

WEEK 104
F-VASI Score: 0.17
81% IMPROVEMENT
FROM BASELINE.

Polarized images. Results not typical.
Individual results may vary.

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F-VASI75 data

View the data

View study design

PATIENTS WHO ACHIEVED COMPLETE OR NEARLY COMPLETE REPIGMENTATION (F-VASI90) AT WEEKS 24, 52, and 104

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION MET F-VASI90 AT WEEK 241

  • Age: 14
  • Sex: Female
  • Fitzpatrick Skin Type: IV
  • Duration of Disease: 10.4 Years (since initial diagnosis)
  • Duration        
    of Disease:
    10.4 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 1.0

WEEK 12
F-VASI Score: 0.3

WEEK 24
F-VASI Score: 0.1
90% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.01
99% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION MET F-VASI90 AT WEEK 241

  • Age: 56
  • Sex: Male
  • Fitzpatrick Skin Type: III
  • Duration of Disease: 21.6 Years (since initial diagnosis)
  • Duration
    of Disease:
    21.6 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 1.62

WEEK 12
F-VASI Score: 0.45

WEEK 24
F-VASI Score: 0.14
91% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.12
93% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION MET F-VASI90 AT WEEK 521

  • Age: 38
  • Sex: Female
  • Fitzpatrick Skin Type: II
  • Duration of Disease: 17.0 Years (since initial diagnosis)
  • Duration
    of Disease:
    17.0 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 1.08

WEEK 12
F-VASI Score: 0.12

WEEK 24
F-VASI Score: 0.17
84% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.06
94% IMPROVEMENT
FROM BASELINE.

Polarized images. Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION MET F-VASI90 AT WEEK 521

  • Age: 13
  • Sex: Female
  • Fitzpatrick Skin Type: II
  • Duration of Disease: 2.6 Years (since initial diagnosis)
  • Duration
    of Disease:
    2.6 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 0.7

WEEK 12
F-VASI Score: 0.8

WEEK 24
F-VASI Score: 0.1
86% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.05
93% IMPROVEMENT
FROM BASELINE.

Polarized images. Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION MET F-VASI90 AT WEEK 1041

  • Age: 56
  • Sex: Male
  • Fitzpatrick Skin Type: II
  • Duration of Disease: 42.6 Years (since initial diagnosis)
  • Duration
    of Disease:
    42.6 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 0.5

WEEK 24
F-VASI Score: 0.4
20% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.25
50% IMPROVEMENT
FROM BASELINE.

WEEK 104
F-VASI Score: 0.03
94% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

Polarized image.

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F-VASI90 Data

View the data

View study design

PATIENTS WHO ACHIEVED F-VASI50 AT WEEKS 24 AND 52

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view their results

 
 

A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION ACHIEVED F-VASI50 AT WEEK 241

  • Age: 56
  • Sex: Male
  • Fitzpatrick Skin Type: III
  • Duration of Disease: 46.5 Years (since initial diagnosis)
  • Duration
    of Disease:
    46.5 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 1.23

WEEK 12
F-VASI Score: 0.98

WEEK 24
F-VASI Score: 0.45
63% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.43
65% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION MET F-VASI50 AT WEEK 241

  • Age: 43
  • Sex: Female
  • Fitzpatrick Skin Type: IV
  • Duration of Disease: 18.5 Years (since initial diagnosis)
  • Duration
    of Disease:
    18.5 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 0.7

WEEK 12
F-VASI Score: 0.23

WEEK 24
F-VASI Score: 0.19
73% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.05
93% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION ACHIEVED F-VASI50 AT WEEK 521

  • Age: 45
  • Sex: Female
  • Fitzpatrick Skin Type: IV
  • Duration of Disease: 13.9 Years (since initial diagnosis)
  • Duration
    of Disease:
    13.9 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 1.5

WEEK 12
F-VASI Score: 1.0

WEEK 24
F-VASI Score: 1.0
33% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.5
67% IMPROVEMENT
FROM BASELINE.

Polarized images. Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION ACHIEVED F-VASI50 AT WEEK 521

  • Age: 46
  • Sex: Female
  • Fitzpatrick Skin Type: III
  • Duration of Disease: 27.8 Years (since initial diagnosis)
  • Duration
    of Disease:
    27.8 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 0.7

WEEK 12
F-VASI Score: 0.47

WEEK 24
F-VASI Score: 0.39
44% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.34
51% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION ACHIEVED F-VASI50 AT WEEK 521

  • Age: 61
  • Sex: Female
  • Fitzpatrick Skin Type: IV
  • Duration of Disease: 11.6 Years (since initial diagnosis)
  • Duration
    of Disease:
    11.6 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 0.84

WEEK 12
F-VASI Score: 0.81

WEEK 24
F-VASI Score: 0.5
40% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.3
64% IMPROVEMENT
FROM BASELINE.

Polarized images. Results not typical. Individual results may vary.

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A CLINICAL TRIAL PARTICIPANT WHOSE REPIGMENTATION ACHIEVED F-VASI50 AT WEEK 521

  • Age: 48
  • Sex: Female
  • Fitzpatrick Skin Type: V
  • Duration of Disease: 7.6 Years (since initial diagnosis)
  • Duration
    of Disease:
    7.6 years
    (since initial diagnosis)

WEEK 0
F-VASI Score: 0.5

WEEK 12
F-VASI Score: 0.45

WEEK 24
F-VASI Score: 0.45
10% IMPROVEMENT
FROM BASELINE.

WEEK 52
F-VASI Score: 0.2
60% IMPROVEMENT
FROM BASELINE.

Results not typical. Individual results may vary.

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F-VASI50 Data

View the data

View study design

PATIENTS WHO ACHIEVED T-VASI75 AT WEEKS 24, 52, or 104

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view their results

 
 
T-VASI75 PATIENT 1: NECK AND KNEE  
Selected images of nonfacial lesions included in the T-VASI for a trial participant whose repigmentation achieved T-VASI75 at Week 52. Photos do not represent all lesions.1
  • Age: 16
  • Sex: Female
  • Fitzpatrick Skin Type: IV
  • Duration of Disease: 6.1 Years (since initial diagnosis)
  • Duration      
    of Disease:
    6.1 years      
    (since initial diagnosis)

WEEK 0

WEEK 24

WEEK 52

Results not typical. Individual results may vary.

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T-VASI75 PATIENT 2: HANDS AND ARM      
Selected images of nonfacial lesions included in the T-VASI for a trial participant whose repigmentation achieved T-VASI75 at Week 52. Photos do not represent all lesions.1
  • Age: 56
  • Sex: Male
  • Fitzpatrick Skin Type: III
  • Duration of Disease: 21.6 Years (since initial diagnosis)
  • Duration      
    of Disease:
    21.6 years      
    (since initial diagnosis)

WEEK 0

WEEK 24

WEEK 52

Results not typical. Individual results may vary.

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T-VASI75 PATIENT 3: ARM      
Selected images of nonfacial lesions included in the T-VASI for a trial participant whose repigmentation achieved T-VASI75 at Week 104. Photos do not represent all lesions.1
  • Age: 56
  • Sex: Male
  • Fitzpatrick Skin Type: III
  • Duration of Disease: 7.4 Years (since initial diagnosis)
  • Duration      
    of Disease:
    7.4 years      
    (since initial diagnosis)

WEEK 0

WEEK 24

WEEK 52

WEEK 104

Polarized images. Results not typical. Individual results may vary.

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T-VASI75 data

View the data

View study design

PATIENTS WHO ACHIEVED T-VASI50 AT WEEKS 24, 52, or 104

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view their results

 
 
T-VASI50 PATIENT 1: elbow and foot
Selected images of nonfacial lesions included in the T-VASI for a trial participant whose repigmentation achieved T-VASI50 at Week 24. Photos do not represent all lesions.1
  • Age: 65
  • Sex: Female
  • Fitzpatrick Skin Type: III
  • Duration of Disease: 23.2 Years (since initial diagnosis)
  • Duration
    of Disease:
    23.2 years
    (since initial diagnosis)

WEEK 0

WEEK 12

WEEK 24

Results not typical. Individual results may vary.

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T-VASI50 PATIENT 2: ARM AND CHEST
Selected images of nonfacial lesions included in the T-VASI for a trial participant whose repigmentation achieved T-VASI50 at Week 24. Photos do not represent all lesions.1
  • Age: 66
  • Sex: Female
  • Fitzpatrick Skin Type: II
  • Duration of Disease: 54.4 Years (since initial diagnosis)
  • Duration
    of Disease:
    54.4 years
    (since initial diagnosis)

WEEK 0

WEEK 12

WEEK 24

Results not typical. Individual results may vary.

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T-VASI50 PATIENT 3: abdomen
Selected images of nonfacial lesions included in the T-VASI for a trial participant whose repigmentation achieved
T-VASI50 at Week 52. Photos do not represent all lesions.1
  • Age: 48
  • Sex: Female
  • Fitzpatrick Skin Type: IV
  • Duration of Disease: 19.8 Years (since initial diagnosis)
  • Duration
    of Disease:
    19.8 years
    (since initial diagnosis)

WEEK 0

WEEK 24

WEEK 52

Results not typical. Individual results may vary.

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T-VASI50 PATIENT 4: HAND
Selected images of nonfacial lesions included in the T-VASI for a trial participant whose repigmentation achieved T-VASI50 at Week 104. Photos do not represent all lesions.1
  • Age: 42
  • Sex: Female
  • Fitzpatrick Skin Type: IV
  • Duration of Disease: 19.7 Years (since initial diagnosis)
  • Duration
    of Disease:
    19.7 years
    (since initial diagnosis)

WEEK 0

WEEK 24

WEEK 52

WEEK 104

Results not typical. Individual results may vary.

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T-VASI50 data

View the data

View study design

A PATIENT’S PERSPECTIVE

Clinical trial photos can be compelling, but they don’t tell the whole tale. Come listen to patients speak about how repigmentation with OPZELURA helped them.

OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use.2

VIEW PATIENT VIDEOS

Setting Patient Expectations

View our checklist for setting patient expectations: progress takes time!

View the checklist
DOSING INFO FOR OPZELURA

Review how and where to apply OPZELURA.

VIEW DOSING INFO

Important Safety Information and indication

 

INDICATION

OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS
Patients treated with oral Janus kinase (JAK) inhibitors for inflammatory conditions are at risk for serious infections that may lead to hospitalization or death. These include:
  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Other bacterial or viral infections, including herpes zoster, due to opportunistic pathogens.
Avoid use in patients with an active, serious infection. If a serious infection develops, stop OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to use in patients with chronic or recurrent infection. Closely monitor patients for the development of signs of infection during and after treatment with OPZELURA.

Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.

No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA; however, cases were reported in clinical trials of oral JAK inhibitors to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to treatment. Monitor patients for the development of signs and symptoms of TB.

Viral reactivation, including cases of herpes virus reactivation, were reported in clinical trials with JAK inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.

Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA is not recommended in patients with active hepatitis B or hepatitis C.

POST-MARKETING SAFETY

In a large randomized postmarketing safety study of rheumatoid arthritis (RA) patients 50 years and older with at least one cardiovascular risk factor, the following were higher with an oral JAK inhibitor than with a tumor necrosis factor (TNF) blocker:

all-cause mortality, major adverse cardiovascular events (defined as cardiovascular death, myocardial infarction, and stroke), thrombosis, malignancies (excluding non-melanoma skin cancer [NMSC]).

Consider the benefits and risks prior to initiating or continuing therapy with OPZELURA. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

MALIGNANCIES

Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. Patients who are current or past smokers are at increased risk. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.

Consider the benefits and risks prior to initiating therapy with OPZELURA, particularly in patients:

  • with a known malignancy (other than successfully treated non-melanoma skin cancers),
  • who develop a malignancy when on treatment,
  • with cardiovascular risk factors and
  • who are current or past smokers.

Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment. Limit exposure to sunlight and UV light with protective clothing and broad-spectrum sunscreen.

THROMBOSIS
Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious, and some resulted in death. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.
CYTOPENIAS

Thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for patients who have a known history of these events prior to initiating therapy. Perform CBC monitoring as clinically indicated. Discontinue OPZELURA if symptoms associated with clinically significant decreases in laboratory values occur.

POTENTIAL RISKS RELATED TO JAK INHIBITION

Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, as well as hypoglycemia in patients with diabetes.

ADVERSE REACTIONS

In nonsegmental vitiligo, the most common adverse reactions (≥1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.

PREGNANCY REGISTRY

There is a registry that monitors pregnancy outcomes in persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463 or visiting www.opzelura.pregnancy.incyte.com.

LACTATION

Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

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

OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients

Important Safety Information

Important Safety Information and indication

Serious Infections

Patients treated with oral Janus kinase (JAK) inhibitors for inflammatory conditions are at risk for serious infections that may lead to hospitalization or death. These include:

Patients treated with oral Janus kinase (JAK) inhibitors for inflammatory conditions are at risk for serious infections that may lead to hospitalization or death. These include:

References: 1. Data on File. Incyte Corporation. 2. OPZELURA Prescribing Information. Wilmington, DE: Incyte Corporation.