OPZELURA is a prescription medicine used on the skin (topical) for the treatment of the 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.
FREQUENTLY ASKED QUESTIONS ABOUT OPZELURA
HAVE A QUESTION ABOUT OPZELURA?
Navigating nonsegmental vitiligo may bring lots of uncertainty. Here are answers to the most popular questions people have when starting their repigmentation journey with OPZELURA.
ABOUT OPZELURA
OPZELURA is a prescription medicine used to treat nonsegmental vitiligo in adults and children 12 years of age and older. It is applied to the skin to help restore lost color (repigmentation) in affected areas. OPZELURA is an FDA-approved treatment option for people with nonsegmental vitiligo.
OPZELURA is thought to work by targeting certain immune signals in the body that are involved in nonsegmental vitiligo. It helps reduce the immune response that affects pigment-producing cells, allowing skin color to gradually return in treated areas over time.
OPZELURA can be used by adults and children 12 years of age and older with nonsegmental vitiligo. It is prescribed for people who may benefit from a topical treatment to help restore skin color in affected areas.
Yes. OPZELURA is the first and only FDA-approved prescription cream for nonsegmental vitiligo.
Key points:
- Topical cream applied directly to depigmented skin
- Approved for adults and children 12 years and older
- Designed to help restore skin pigment over time
See What Is OPZELURA? for details.
ABOUT VITILIGO
Vitiligo is a long-term skin condition that causes loss of skin color, leading to white patches on different areas of the body. The most common type is nonsegmental vitiligo, which often appears on the face, hands, arms, and other areas and may spread over time.
Vitiligo is caused by the immune system attacking pigment-producing cells (melanocytes) in the skin. This leads to loss of color in affected areas. Certain factors such as stress, skin injury, or genetics may trigger vitiligo in some people.
Yes, vitiligo is considered an autoimmune condition. This means the immune system mistakenly attacks the body’s own pigment-producing cells, which leads to loss of skin color.
Vitiligo is considered a chronic condition and cannot currently be cured or permanently reversed. However, repigmentation is possible for some people with appropriate treatment.
With prescription treatments like OPZELURA, some patients may experience a gradual return of skin color in affected areas over time. Results can vary based on factors such as treatment duration, and the areas of the body being treated. Continued treatment may be needed to help maintain regained pigment.
See Repigmentation Results to learn more about repigmentation over time.
Treatment options for vitiligo focus on supporting repigmentation in affected areas. One option is prescription topical treatment, such as OPZELURA, which is FDA-approved for nonsegmental vitiligo and is applied directly to the skin.
Treatment approaches may vary based on factors like the type of vitiligo, areas affected, and individual response. A healthcare provider can help determine the most appropriate treatment plan and set realistic expectations.
USING OPZELURA
Apply a thin layer of OPZELURA to the affected areas of the skin twice daily. It should be used only on the skin and not in the eyes, mouth, or inside the body. Follow your healthcare provider’s instructions and use it consistently to support repigmentation over time.
Yes, other skincare products can be used with OPZELURA, but they should not be applied at the same time. Apply OPZELURA to clean, dry skin and allow it to fully absorb (about 10 minutes) before applying non- medicated products such as sunscreen, moisturizers, or makeup. Talk to your healthcare provider if you have questions about how to use OPZELURA with other products.
You can talk to your dermatologist about OPZELURA by discussing your vitiligo symptoms, treatment goals, and previous treatments. Bringing photos or notes about changes in your skin can help your provider evaluate whether OPZELURA may be an appropriate option for you.
OPZELURA can be applied to affected areas of the skin, including commonly affected areas such as the face, neck, arms, and hands. It should be used only on the skin and not in the eyes, mouth, or inside the body.
OPZELURA should be applied twice daily to the affected areas of the skin. Using it consistently as directed can help support repigmentation over time.
OPZELURA should be applied exactly as directed by a healthcare provider.
Key application steps:
- Apply a thin layer to depigmented areas of skin
- Use twice daily, every day
- Treat up to 10% of body surface area
- Apply only to clean, dry skin
See How To Use OPZELURA for step-by-step guidance.
WHAT TO EXPECT (RESULTS)
Repigmentation may begin to appear within several months after starting treatment with OPZELURA, with continued improvement at 6 months, 1 year, and up to 2 years. Treatment should be evaluated at 6 months, and some patients may need longer use for a satisfactory response. If no improvement is seen by 6 months, reassess treatment with a healthcare provider.
Staying consistent with OPZELURA use is important to support repigmentation over time. Applying it twice daily as directed, tracking changes in your skin, and following up with your healthcare provider can help you stay on track. Taking photos over time may also help you see gradual improvements.
The first signs of repigmentation with OPZELURA may appear as small spots of color returning within white patches of skin. These areas may gradually expand and blend with surrounding skin over time. Results can vary, and continued use as directed supports visible improvement.
The extent of repigmentation with OPZELURA can vary. In clinical studies, about 33% of patients achieved at least 75% improvement on the face at 6 months, 51% at 1 year, and 66% at 2 years with continued use.
Clinical studies show that repigmentation can occur over time with continued treatment, though results vary by individual.
Key findings for OPZELURA include:
- Gradual repigmentation observed over multiple time points
- Improvements documented at 6 months, 1 year, and 2 years
- A higher proportion of patients achieved meaningful improvement with continued use over time
- Repigmentation trends were consistently measured on areas of the face
These studies also showed that repigmentation is a progressive process and may take several months to become noticeable.
See Repigmentation Results to learn more about what clinical studies show.
SAFETY & SIDE EFFECTS
The most common side effects of OPZELURA (occurring in at least 1% of patients) include:
- Acne at the application site
- Itching at the application site
- Redness at the application site
- Common cold (nasopharyngitis)
- Headache
- Urinary tract infection
- Fever
COST, COVERAGE, & SAVINGS
Yes. OPZELURA offers financial support programs to help reduce treatment costs. Eligible patients with commercial insurance may access a Copay Savings Program, while those without adequate insurance may qualify for assistance through the IncyteCARES Patient Assistance Program, subject to eligibility.
The list price (Wholesale Acquisition Cost) of OPZELURA is $2,094 per tube.
However, the amount you pay may vary depending on your insurance coverage, pharmacy, and eligibility for savings programs.
Eligible patients with commercial insurance may qualify for the OPZELURA Copay Savings Program, which may allow them to pay significantly less at the pharmacy, subject to program terms and eligibility requirements.
Savings availability can depend on factors such as insurance type, individual eligibility, and annual program limits.
See Copay Savings Program to review eligibility details and how to get started.
SUPPORT AND RESOURCES
The OPZELURA patient support program provides resources to help patients access treatment and navigate insurance coverage.
This may include support with reimbursement, coverage information, and tools to help patients get started with OPZELURA and stay on treatment.
OPZELURA offers the OPZELURA Patient Support, designed to help patients navigate their treatment journey from prescription to pickup. The program can help with understanding insurance coverage and prior authorization, exploring copay savings options, and staying on track with treatment.
See Patient Support Program to explore available resources and get started.
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.
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, which are medicines that affect your immune system and can lower your ability 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 using 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) and major cardiovascular events: Increased risk of death and major cardiovascular events (eg, heart attack or stroke) has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking JAK inhibitors by mouth, especially current or past smokers.
Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. People taking JAK inhibitors by mouth have reported lymphoma and other cancers and are at higher risk of certain cancers including lymphoma and lung cancer, especially if they have ever smoked. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment. Limit the amount of time you spend in the sun, wear protective clothing and use a broad-spectrum sunscreen.
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. DVT and PE have happened more often in people taking JAK inhibitors by mouth who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor.
Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia, lymphopenia, leukopenia). Your healthcare provider may do a blood test to check your blood cell counts during your treatment and may stop your treatment if signs or symptoms of low blood cell counts happen.
Potential risks from Janus kinase (JAK) inhibition: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides. Low blood sugar in people with diabetes has happened after taking JAK inhibitors by mouth.
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 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. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463 or www.opzelura.pregnancy.incyte.com. This registry is intended to collect information about the health of you and your baby
- 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, blood clot, 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
- swelling, pain, or tenderness in one or both legs
- 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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