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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.

Discussing
Opzelura

It all starts
with a Chat

Whether you’re newly diagnosed or simply ready to open a fresh chapter in your vitiligo story, you should start with some real talk between you and a healthcare provider. OPZELURA may not be for everyone. Your healthcare provider can help determine whether OPZELURA is the right choice for you or someone you care for. Better yet, they can help you map out the best treatment plan for you.

But first, there’s the talk with your healthcare provider.
If you’re not sure how to get it started, we’re here to help.

Start with trust

A trusting relationship with your healthcare provider is an important part of treatment. Connect with friends, family or a trusted healthcare provider to see if there’s a specialist they’d recommend.

Look for a specialist

To assess your vitiligo and to map out a treatment plan, finding a healthcare provider who specializes in skin conditions could be a great place to start.

Do a little homework

Let’s be real: It may take a while to find the right fit with a healthcare provider in your area. In the meantime, start keeping track of your condition and preparing for a productive first visit.

4 steps to an informative discussion

If you’re looking for a productive conversation, try to form an open and honest bond with your healthcare provider. That’s a good place to start, whether you’re meeting the provider for yourself or attending an appointment with someone you care for. Here’s a 4-step guide to navigating that all-important conversation—and building it into a long-term partnership with your healthcare provider.

Step 1 - Come prepared

 

Before your next appointment, take some time to consider topics or questions you want to discuss with your healthcare provider.

  • Write down what you hope to gain from the interaction. If you’re looking for a new treatment, be ready to make that clear.
  • Document your history with vitiligo (where spots have appeared, how quickly they grow or change, what treatments you’ve tried). Consider building a timeline using photos as well!
  • As a caregiver, take notes for your loved one during the discussion, so you can review the details together afterward.
  • Assess the impact vitiligo has had on your life—not just the surface, but how it’s affected you socially and emotionally. For example, have you skipped any important events because of how you felt about your vitiligo? Are there certain life events that make you feel certain ways about your vitiligo?
  • If you’re caring for someone with vitiligo, reassure them with your support. Align on their goals before the appointment and be ready to help them through the conversation.
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Step 2 - Make a plan

 

When you meet, have a candid conversation that leaves you with actionable steps to bring home.

  • Give them the full picture of your vitiligo experience and your treatment goals—you can check your prepared notes or share photos, if that helps.
  • Be clear about what you are hoping for in a treatment for nonsegmental vitiligo.
  • If you and your healthcare provider decide that OPZELURA is right for you, make note of their instructions for using OPZELURA, including the area of the skin to apply and how much to use in each application.
  • Discuss ways to help make your twice-daily application of OPZELURA a part of your regular routine.
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Step 3 - Stay on track

 

When it comes to treating nonsegmental vitiligo, consistency is important. That means you might want to empower yourself with the support systems you need to make your treatment regimen feel like second nature. If you’re just getting started, check out some of our tools for helping you stick with it.
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Step 4 - Keep in touch

 

That initial discussion with your healthcare provider can be the beginning of a lasting relationship.

  • Your healthcare provider may advise meeting more frequently than every six months.
  • Results may vary, and your skin may require a full six months to start showing results—that's why it's important to continuously apply OPZELURA twice a day, as directed by your healthcare provider.
  • In between visits, track your progress by setting weekly or monthly reminders to photograph your skin.
  • Download our treatment journal as a tool to record thoughts and questions for your doctor on a monthly basis.
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Find a nearby specialist

If you don’t know a provider in your area, here is a tool that can help. This Zocdoc* tool uses your ZIP code to connect you with local specialists. Meet with them virtually to see if they are the right fit for you.

Find a specialist

*Please note that the Zocdoc tool is not controlled by Incyte Corporation, and the list of Healthcare Professionals offered is generated by Zocdoc and not screened by Incyte.

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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.