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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.

How to Use
Opzelura

A topical cream
that can fit into
your routine

OPZELURA is not a steroid, pill, ointment, or injection—and you can apply it yourself. It’s a topical cream that is applied twice daily on depigmented areas of skin on up to 10% of body surface area. Make sure to follow the instructions below for recommendations on how and when to use OPZELURA.

How to use

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.

Twice a day—every day
  • Consistently apply OPZELURA two times each day to the affected skin on up to 10% of body surface area, perhaps as part of your morning and evening routines.
  • Apply a thin layer, as directed by your healthcare provider.
  • Wash your hands after applying OPZELURA, unless hands are being treated. If someone else applies OPZELURA, they should wash their hands after applying OPZELURA.
  • Use OPZELURA as instructed by your healthcare provider.
After showering & shaving

Please talk with your healthcare provider about how best to use OPZELURA in relation to any personal hygiene routines or cosmetic products.

How much to use

Apply a thin layer of OPZELURA twice daily on your body’s affected areas—up to 10% of your body based on the direction from your healthcare provider. That’s about the size of ten handprints. If you’re still unsure, ask your healthcare provider for guidance on how much to use and where you should apply OPZELURA. Do not use more than one 60 gram tube each week.

OPZELURA cream can be applied to sensitive areas like around the eyes (including eyelids), mouth, and genitals.*

*OPZELURA is for use on the skin only. Do not use in the eyes, mouth, or vagina.

Caring for someone with vitiligo?

You may be an important piece of their support system. By getting to know the specifics of their treatment plan, you can help them stay consistent with their new schedule.

The first signs of repigmentation

New skin color is made by pigment-producing cells (melanocytes) that mainly come from the hair follicles. So, if your skin begins to repigment, the first freckles of pigment are likely to appear in the areas around the hairs of your depigmented skin.

Repigmentation: What’s possible

The following photos represent two patients' results before treatment with OPZELURA, after 3 months of treatment, and after 6 months of treatment. Satisfactory repigmentation may sometimes take longer than 6 months.

Before treatment
with OPZELURa

Patient's skin before treatment with OPZELURA

Before treatment
with OPZELURa

After 3 months of
treatment with OPZELURA

Patient's skin after 3 months of treatment with OPZELURA

After 3 months of
treatment with OPZELURA

After 6 months of
treatment with OPZELURA

Patient's skin after 6 months of treatment with OPZELURA

After 6 months of
treatment with OPZELURA

Patient's skin before treatment with OPZELURA

Before treatment
with OPZELURa

Patient's skin after 3 months of treatment with OPZELURA

After 3 months of
treatment with OPZELURA

Patient's skin after 6 months of treatment with OPZELURA

After 6 months of
treatment with OPZELURA

Individual results may vary. Results not typical.

Areas where the hair follicles are sparse, absent or have turned white may not repigment.

A fresh discussion with
your healthcare provider

Start exploring OPZELURA by talking with your healthcare
provider about whether or not this treatment may be
right for you. If you haven't found a healthcare provider,
need more support in getting started, or simply can't find
the words, we’re here to help.

Keep up with information
and updates

Receive timely information, updates,
and helpful tips about OPZELURA sent
directly to you.

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.