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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.

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Nonsegmental Vitiligo

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Frequently Asked Questions about OPZELURA

 

About OPZELURA

OPZELURA is a topical JAK inhibitor indicated for the treatment of nonsegmental vitiligo. It is applied to affected skin to help support repigmentation by targeting pathways involved in depigmentation.1,2

OPZELURA is indicated for use in adults and children 12 years of age and older with nonsegmental vitiligo. It helps support repigmentation of affected skin areas in patients.1

Treatment options for nonsegmental vitiligo include topicals and phototherapy aimed at helping repigmentation. OPZELURA is a non-steroidal topical option that targets underlying pathways involved in depigmentation.1,3

 

Mechanism of Action

OPZELURA works by inhibiting Janus kinase (JAK1 and JAK2), which are involved in immune signaling associated with nonsegmental vitiligo. By blocking JAK-STAT signaling, it is thought to help reduce immune-mediated processes that contribute to loss of skin pigmentation.1,2,4

For more details, visit the Mechanism of Action page.

The IFN-γ-mediated JAK-STAT signaling pathway plays a role in immune signaling processes associated with nonsegmental vitiligo, including pathways that contribute to melanocyte dysfunction and loss of skin pigmentation.1,4,5

 

Efficacy & Clinical Results

Clinical trials of OPZELURA in patients with nonsegmental vitiligo demonstrated improvements in repigmentation of both facial and body areas. These endpoints were assessed using validated measures, including the Facial Vitiligo Area Scoring Index (F-VASI) and Total Vitiligo Area Scoring Index (T-VASI), which evaluate changes in depigmentation over time.1,7

In clinical studies of patients with nonsegmental vitiligo, ≈30% of patients treated with OPZELURA since Day 1 achieved at least 75% improvement in facial repigmentation (F-VASI75) at Week 24, and ≈51% of patients achieved F-VASI75 at Week 52. These results reflect clinically meaningful improvement in facial pigmentation over time.1,7

Learn more about Facial Repigmentation Results with OPZELURA.

In clinical studies of patients with nonsegmental vitiligo, 51% of patients treated with OPZELURA since Day 1 achieved at least 50% improvement in total body repigmentation (T-VASI50) at Week 52. These results reflect improvement in repigmentation of nonfacial areas over time.7

Learn more about Body Repigmentation Results with OPZELURA.

Repigmentation with OPZELURA for nonsegmental vitiligo may be observed over time, with clinical studies evaluating outcomes at 24 weeks and beyond. Improvements in repigmentation can continue with ongoing treatment, and results may vary depending on the individual and the area of skin being treated.1,8

 

Dosing

OPZELURA is applied as a thin layer twice daily to the affected areas of skin with nonsegmental vitiligo, covering up to 10% of the body surface area.1

It may be applied to sensitive skin areas, including around the eyes and mouth and on external genital areas.1

It is for topical use only and should not be used in the eyes, mouth, or intravaginally.1

See full guidance on the Dosing and Administration page.

The duration of treatment with OPZELURA in nonsegmental vitiligo may vary based on patient response and treatment goals. Clinical studies evaluated repigmentation outcomes over 2 years, with continued improvement observed with ongoing use. Treatment decisions should be based on clinical assessment of response over time.1

Patients starting OPZELURA for nonsegmental vitiligo can expect repigmentation to occur gradually and vary by individual and treatment area. Clinical studies evaluated outcomes over 24 weeks and beyond, with continued improvement observed with ongoing use. Consistent twice-daily application supports assessment of treatment response over time.1,8

 

Safety & Adverse Events

In clinical trials of OPZELURA in patients with nonsegmental vitiligo, the most common adverse reactions (≥1%) over 24 weeks included:1

  • Application site acne
  • Application site pruritus
  • Nasopharyngitis
  • Headache
  • Urinary tract infection
  • Application site erythema
  • Pyrexia

Learn more about Adverse Reactions reported with OPZELURA.

 

Access & Savings

Support resources include programs and tools that assist with insurance coverage, reimbursement support, and access to specialty pharmacies, as well as educational resources to support treatment initiation and continuation. For more information, visit the Access page.

The OPZELURA Copay Savings Card can be used by patients with commercial prescription insurance coverage for OPZELURA. It is not available for patients enrolled in government-funded healthcare programs such as Medicare, Medicaid, TRICARE, or Veterans Affairs healthcare.

PROVEN REPIGMENTATION

OPZELURA has been shown to help
repigment the skin.1

SEE THE DATA

LEARN MORE ABOUT VITILIGO

Review information about vitiligo,
an autoimmune condition.9

GET VITILIGO FACTS

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 12

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. OPZELURA Prescribing Information. Wilmington, DE: Incyte Corporation. 2. Rosmarin D, Pandya AG, Lebwohl M, et al. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020;396(10244):110-120. doi:10.1016/S0140-6736(20)30609-7 3. Kubelis-Lopez DE, Zapata-Salazar NA, Said-Fernández SL, et al. Updates and new medical treatments for vitiligo (Review). Exper Ther Med. 2021. doi: 10.3892/etm.2021.10229 4. Strassner JP, Harris JE. Understanding mechanisms of autoimmunity through translational research in vitiligo. Curr Opin Immunol. 2016;43:81-88. doi:10.1016/j.coi.2016.09.008 5. Howell MD, Kuo FI, Smith PA. Targeting the Janus kinase family in autoimmune skin diseases. Front Immunol. 2019;10:2342. doi:10.3389/fimmu.2019.02342 6. 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. 7. Data on File. Incyte Corporation. 8. Birlea SA, Goldstein NB, Norris DA. Repigmentation through melanocyte regeneration in vitiligo. Dermatol Clin. 2017;35(2):205-218. doi:10.1016/j.det.2016.11.015 9. Bergqvist C, Ezzedine K. Vitiligo: a review. Dermatol. 2020;236(6):571-592. doi:10.1159/000506103