This site is intended for US healthcare professionals.

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

Change condition>

 

FACIAL REPIGMENTATION RESULTS

PROVEN TO REPIGMENT
THE FACE1

A person showing symptoms of nonsegmental vitiligo A person showing symptoms of nonsegmental vitiligo
24- & 52-WEEK DATA
2-YEAR REPIGMENTATION DATA
MAINTENANCE DATA
Sam, an OPZELURA patient

Sam applied OPZELURA for a year, working toward repigmentation.* Listen to Sam speak about her results with OPZELURA, and the potential of repigmentation for your patients.

Sam’s Journey

*Not a clinical trial participant. Because this is a real-world patient, there may be other factors influencing treatment results, and individual results may vary.

75% facial repigmentation at 24 and 52 weeks

75% FACIAL REPIGMENTATION

Approximately 1 in 3 patients at 24 weeks
Approximately 1 in 2 patients at 52 weeks

Primary endpoint measured F-VASI75 at Week 24 across two studies (TRuE-V1 and TRuE-V2): 29.9% for OPZELURA vs. 7.5% for vehicle (P < 0.0001) and 29.9% for OPZELURA vs. 12.9% for vehicle (P < 0.01), respectively.1-3*†

View f-vasi75 photos

F-VASI75 RESULTS THROUGH WEEK 52 (TRuE-V1 AND TRuE-V2 COMBINED)1,2

F-VASI75 52-week data
F-VASI75 52-week data

After the initial 24-week double-blind period, patients in both trial arms could elect to apply OPZELURA twice daily for 28 weeks in the open-label extension. Extension data are as observed.1

Limitations of an open-label extension: Open-label treatment-extension data were reported as observed. In an open-label extension there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out. No conclusions of efficacy or safety should be made based on the extension study results.

The line graph above shows the pooled F-VASI75 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. About a third of the patients who applied OPZELURA achieved F-VASI75 at 24 weeks: ≈31% for OPZELURA and ≈10% for vehicle (Week 0 to Week 24). About half the patients remaining in the study who applied OPZELURA from Day 1 achieved F-VASI75 at 52 weeks: ≈51% for OPZELURA and ≈28% for vehicle-to-OPZELURA (Week 24 to Week 52).2

View study design

*P-values from exact logistic regression: [response at Week 24 = treatment + stratification factors (Fitzpatrick skin type I and II vs. Fitzpatrick skin type III, IV, V, and VI, Region North America/Europe)].2

†In TRuE-V1 and TRuE-V2, respectively.

The facial vitiligo area scoring index (F-VASI) is a composite measurement of the overall area of facial vitiligo patches and degree of depigmentation within patches. As assessed, the face did not include surface area of the lips, scalp, or ears.4

During the double-blind period (up to Week 24), multiple imputation was applied to account for missing values.5

During the open-label extension (after Week 24), responses were reported as observed.5

SEE F-VASI90 RESULTS

90% facial repigmentation at 24 and 52 weeks

90% FACIAL REPIGMENTATION

Approximately 1 in 6 patients at 24 weeks
Approximately 1 in 3 patients at 52 weeks

Secondary endpoint measured F-VASI90 across two studies (TRuE-V1 and TRuE-V2): 15.5% for OPZELURA vs. 2.2% for vehicle (P < 0.01) and 15.4% for OPZELURA vs. 1.9% for vehicle (P < 0.05)1-3

View F-VASI90 photos

F-VASI90 RESULTS THROUGH WEEK 52 (TRuE-V1 AND TRuE-V2 COMBINED)2

F-VASI90 Data
F-VASI90 52-week data

After the initial 24-week double-blind period, patients in both trial arms could elect to apply OPZELURA twice daily for 28 weeks in the open-label extension. Extension data are as observed.1

Limitations of an open-label extension: Open-label treatment-extension data were reported as observed. In an open-label extension there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out. No conclusions of efficacy or safety should be made based on the extension study results.

The line graph above shows the pooled F-VASI90 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. About a sixth of the patients who applied OPZELURA achieved F-VASI90 at 24 weeks: ≈16% for OPZELURA and ≈2% for vehicle (Week 0 to Week 24). At Week 52, ≈31% of patients for OPZELURA and ≈14% of patients for vehicle-to-OPZELURA (Week 24 to Week 52) achieved F-VASI90.2

View study design

F-VASI, facial vitiligo area scoring index.

During the double-blind period (up to Week 24), multiple imputation was applied to account for missing values.5

During the open-label extension (after Week 24), responses were reported as observed.5

F-VASI as assessed did not include surface area of the lips, scalp, or ears.4

See F-VASI50 Results

50% facial repigmentation at 24 and 52 weeks

50% FACIAL REPIGMENTATION

Approximately 1 in 2 patients at 24 weeks
Approximately 3 in 4 patients at 52 weeks

Secondary endpoint measured

F-VASI50 across two studies (TRuE-V1 and TRuE-V2): 51.5% for OPZELURA vs. 17.2% for vehicle and 51.4% for OPZELURA vs. 23.4% for vehicle (P < 0.0001)3

View F-VASI50 photos

F-VASI50 RESULTS THROUGH WEEK 52 (TRuE-V1 AND TRuE-V2 COMBINED)2

F-VASI50 52-week data
F-VASI50 52-week data

After the initial 24-week double-blind period, patients in both trial arms could elect to apply OPZELURA twice daily for 28 weeks in the open-label extension. Extension data are as observed.1

Limitations of an open-label extension: Open-label treatment-extension data were reported as observed. In an open-label extension there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out. No conclusions of efficacy or safety should be made based on the extension study results.

The line graph above shows the pooled F-VASI50 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. About half of the patients who applied OPZELURA achieved F-VASI50 at 24 weeks: ≈52% for OPZELURA and ≈19% for vehicle (Week 0 to Week 24). At Week 52, ≈75% of patients for OPZELURA and ≈53% of patients for vehicle-to-OPZELURA (Week 24 to Week 52) achieved F-VASI50.2

View study design

F-VASI, facial vitiligo area scoring index.

During the double-blind period (up to Week 24), multiple imputation was applied to account for missing values.5

During the open-label extension (after Week 24), responses were reported as observed.5

F-VASI as assessed did not include surface area of the lips, scalp, or ears.4

 

Among those patients who didn't reach F-VASI90 at 52 weeks:

CONTINUED REPIGMENTATION: 2-YEAR DATA

MANY PATIENTS CONTINUED
TO SEE IMPROVEMENT IN
FACIAL REPIGMENTATION
THROUGH 2 YEARS6

 

The proportion of patients who achieved F-VASI75 increased with twice-daily OPZELURA treatment through 104 weeks6

F-VASI75 (WEEKS 52 TO 104)6

F-VASI75 104-week data

F-VASI75 (WEEKS 52 TO 104)6

F-VASI75 104-week data

Open-label treatment-extension data were reported as observed. In an open-label extension there is a potential for enrichment of the long-term data in the remaining patient populations. No conclusions of efficacy or safety should be made based on the extension study results.

The line graph above shows F-VASI75 scores for patients applying OPZELURA from Week 52 to Week 104 in the subset of patients who did not reach F-VASI90 at Week 52. Among patients who applied OPZELURA from Day 1, the proportion of patients who achieved F-VASI75 more than doubled from ≈31% at Week 52 to ≈66% at Week 104. Among patients who switched from vehicle to OPZELURA at Week 24, the proportion of patients who achieved F-VASI75 nearly tripled from ≈16% at Week 52 to ≈47% at Week 104.6

 

TREAT FOR MAINTENANCE2,7

AMONG THOSE WHO REACHED F-VASI90 AT 52 WEEKS (n = 116), HIGHER MAINTENANCE WAS OBSERVED IN PATIENTS WHO CONTINUED ON OPZELURA THROUGH 2 YEARS2,7

Maintenance chart
Maintenance chart

No conclusions of efficacy or safety should be made based on the extension study results.

The pie chart above shows F-VASI90 scores from the TRuE-V long-term extension for OPZELURA and vehicle in the subset of patients who reached F-VASI90 at Week 52. About 60% of the patients who applied OPZELURA maintained F-VASI90 at 104 weeks with continued OPZELURA treatment: ≈62% for OPZELURA and ≈21% for vehicle (Week 52 to Week 104). However, ≈24% of patients applying OPZELURA from Week 52 to Week 104 lost F-VASI90 response, compared to ≈55% in the vehicle arm.2,7

*A "loss of response" event was defined as a loss of F-VASI90 response, with a F-VASI90 response defined as ≥90% improvement in F-VASI from baseline (Day 1 of the parent study).7

†Patients were censored from the time-to-relapse analysis in the absence of relapse event, if they discontinued treatment, or if they applied rescue treatment without relapse.2

REPIGMENTATION AFTER RELAPSE

MOST PATIENTS WHO EXPERIENCED RELAPSE AFTER STOPPING TREATMENT (n = 16) REGAINED PIGMENTATION AFTER RE-TREATMENT WITH OPZELURA7

75% n = 12
OF PATIENTS REGAINED F-VASI75 IN A MEDIAN TIME OF 12 WEEKS7
68.8% n = 11
OF PATIENTS REGAINED F-VASI90 IN A MEDIAN TIME OF 15 WEEKS7

If, at any time, a patient in the vehicle group with ≥F-VASI90 loses a clinically meaningful response on the face (<F-VASI75), the patient will receive open-label OPZELURA until Week 104 or the end of treatment.6

Relapse was defined as loss of clinically significant repigmentation (<F-VASI75).7

Watch Sam's Repigmentation Journey video

SAM’S REPIGMENTATION JOURNEY

Listen to Sam speak about her results with OPZELURA, and the potential of repigmentation for your patients.

Sam is not a clinical trial participant. Because she is a real-world patient, there may be other factors influencing treatment results, and individual results may vary. Results not typical.

Sam was compensated for her participation.

(DESCRIPTION) Two microphones sit on a table as upbeat music enters.

(TITLE SLIDE) Opzelura® (ruxolitinib) cream 1.5% ON AIR

(ON-SCREEN TEXT)

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 leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving Janus kinase inhibitors for inflammatory conditions. Regularly monitor patients for infection and manage it promptly.

Higher rate of all-cause mortality, including sudden cardiovascular death has been observed in patients treated with Janus kinase inhibitors for inflammatory conditions.

Lymphoma and other malignancies have been observed in patients treated with Janus kinase inhibitors for inflammatory conditions. Basal cell and squamous cell carcinoma have occurred. Perform periodic skin examinations during treatment and following treatment as appropriate.

Higher rate of MACE (including cardiovascular dealth, myocardial infarction, and stroke) has been observed in patients treated with Janus kinase inhibitors for inflammatory conditions.

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients treated with Janus kinase inhibitors for inflammatory conditions.

Important Safety Information will be discussed in more detail, later in the video.

(DESCRIPTION) Sam K. and Sam N. sit at the table with the microphones and begin talking to each other.

(SPEECH) SAM NICOLINI: So did you track your progress in any way, like taking pictures or--

SAM K: Yeah, I probably took pictures almost daily in the beginning. [LAUGHTER]

Sam K: Hi, I'm Sam, and I have nonsegmental vitiligo, and I'm using OPZELURA.

SAM NICOLINI: Hi, I'm Sam, and I'm a dermatology physician assistant, and I treat nonsegmental vitiligo with OPZELURA.

(ON-SCREEN TEXT) SAM ACTUAL PATIENT TREATED WITH OPZELURA Not a clinical trial participant.

SAM NICOLINI CERTIFIED DERMATOLOGY PHYSICIAN ASSISTANT (PA)

(DISCLAIMER) For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.1 This video is sponsored by Incyte. Sam and Sam were compensated for their time.

(SPEECH) SAM K: But she's not my healthcare provider.

SAM NICOLINI: We're best friends.

SAM K: And this is our OPZELURA Moment - On Air.

(TITLE SLIDE) ON AIR MY MOMENT WITH SAM & SAM

(DESCRIPTION) Sam K. shares her baseline photos with us, where most of her face and neck is depigmented from her vitiligo.

(SPEECH) SAM K: This is probably week one when I first started.

SAM N: Oh my gosh.

SAM K: You can see like my whole face is kind of covered, and down my neck.

SAM N: Yeah.

(ON-SCREEN TEXT) BEFORE TREATMENT2

(DISCLAIMER) OPZELURA was studied as a monotherapy for 24 weeks in 2 identical, phase 3 randomized studies, where 29.9% of those using OPZELURA saw 75% facial vitiligo repigmentation compared to 7.5% and 12.9% of those using vehicle.1

(DESCRIPTION) Sam K. shares her photos at 2 months, where we see the beginning of perifollicular repigmentation.

(SPEECH) SAM K: And then you can see kind of...

SAM N: Yeah, you clearly see, yeah.

Sam K: like the pigment filling in around my eyes...

(DESCRIPTION) Sam K. shares her photos at 8 months, where we see her cheeks and chin have notably more pigment.

(SPEECH) SAM N: Down your cheek area.

SAM K: ...and on my chin.

(DESCRIPTION) Sam K. shares her photos at 10 months, where we see her cheeks and forehead have notably more pigment.

(SPEECH) SAM K: And then most of my cheeks had already come back...

(DESCRIPTION) Sam K. shares her photos at 12 months, where most of her cheeks and forehead have more pigment.

(SPEECH) SAM N: Yeah.

SAM K: ...and my neck started filling in a little bit more. You can see like that whole side.

SAM N: Yep.

(DESCRIPTION) Sam K. shows us pictures from baseline and after one year of treatment, where she has significantly more pigment on her cheeks, forehead, and chin.

(SPEECH) SAM K: Again, like I didn't think there would ever [CHUCKLES] be a treatment that worked for me.

SAM N: Yeah.

[UPBEAT MUSIC] Hey!

(ON-SCREEN TEXT) FRIENDLY TIP: capture progress photos like Sam’s with consistent lighting, angles, and background. Learn what could be possible with OPZELURA at OPZELURAHCP.COM

(DISCLAIMER) OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use.1 Satisfactory patient response may require treatment with OPZELURA for more than 24 weeks. 51% of patients out of 356 who continued using OPZELURA in a less robust extension achieved 75% facial repigmentation at 52 weeks.1,2

(SPEECH) NARRATOR: 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 inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include active tuberculosis, which may present with pulmonary or extrapulmonary disease; invasive fungal infections, including cryptococcosis and pneumocystosis; bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms 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. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB.

Viral reactivation, including cases of herpes virus reactivation, for example, herpes zoster, were reported in clinical trials with Janus kinase 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 initiation is not recommended in patients with active hepatitis B or hepatitis C.

Mortality. In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.

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. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies, excluding non-melanoma skin cancer (NMSC) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy, other than successfully treated non-melanoma skin cancers, patients who develop a malignancy when on treatment, and patients 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 and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

Major adverse cardiovascular events (MACE). In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, and stroke, was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

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. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.

Thrombocytopenia, anemia, and neutropenia. Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA.

Lipid elevations. Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.

Adverse reactions. In nonsegmental vitiligo, the most common adverse reactions (incidence greater than or equal to 1%), are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).

Pregnancy. There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.

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

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

OPZELURA, the OPZELURA logo, Incyte, and the Incyte logo are registered trademarks of Incyte.

© 2023-2024, Incyte.  MAT-OPZ-02339  07/24

VISIBLE RESULTS

See facial and body repigmentation photos of OPZELURA clinical trial participants.

VIEW PATIENT PHOTOS
SETTING PATIENT EXPECTATIONS

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

VIEW THE CHECKLIST

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 inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include:
  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms 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. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB.

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase 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 initiation is not recommended in patients with active hepatitis B or hepatitis C.

MORTALITY

In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.

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. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients 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 and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

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. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.
Thrombocytopenia, Anemia, and Neutropenia

Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA.

Lipid Elevations

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

Adverse Reactions

In nonsegmental vitiligo, the most common adverse reactions (incidence ≥1%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).

Pregnancy Registry

There is a pregnancy registry that monitors pregnancy outcomes in pregnant 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.
See More  

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 inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include:

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

References: 1. OPZELURA Prescribing Information. Wilmington, DE: Incyte Corporation. 2. Data on File. Incyte Corporation. 3. Rosmarin D, Pandya AG, Grimes P, et al. Efficacy and safety of ruxolitinib cream for the treatment of vitiligo: 24-week results from 2 randomized, double-blind phase 3 studies. Presented at the 30th European Academy of Dermatology and Venereology (EADV) Congress; September 29−October 2, 2021; Virtual. 4. Rosmarin D, Pandya AG, Lebwohl M, et al. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020;396(suppl):110-120. doi:10.1016/S0140-6736(20)30609-7 5. Rosmarin D, Passeron T, Pandya AG, et al. Efficacy and safety of ruxolitinib cream monotherapy for the treatment of vitiligo: results from two 52 week phase 3 studies. Presented at the American Academy of Dermatology Annual Meeting; March 25–29, 2022; Boston, MA. 6. Rosmarin D, Sebastian M, Amster M, et al. Facial and total vitiligo area scoring index response shift during 104 weeks of ruxolitinib cream treatment for vitiligo: results from the open-label arm of the TRuE-V long-term extension phase 3 study. Presented at the American Academy of Dermatology Annual Meeting; March 17–21, 2023; New Orleans, LA. 7. Harris JE, Papp K, Forman SB, et al. Relapse and maintenance of clinical response in the randomized withdrawal arm of the TRuE-V long-term extension phase 3 study of ruxolitinib cream in vitiligo. Presented at the American Academy of Dermatology Annual Meeting; March 17–21, 2023; New Orleans, LA.