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Accessing OPZELURA® (ruxolitinib) Cream 1.5%:
A Pathway for Nonsegmental Vitiligo Patients

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IMPORTANT SAFETY CONSIDERATIONS

OPZELURA may cause serious side effects, including:

Serious Infections: OPZELURA is in a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors can lower your ability to fight infections. Serious infections, some fatal, occurred when taking JAK inhibitors by mouth, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses. Some lung infections were seen in people using OPZELURA.

Before starting OPZELURA, tell your healthcare provider right away if you: have an infection (ie fever, sweating, chills), have diabetes, lung disease, HIV, or a weak immune system.

Increased risk of death in people age 50+ with at least one heart disease risk factor when taking JAK inhibitors by mouth.

Cancer and immune system problems: OPZELURA may increase your risk of certain cancers (lymphoma, lung, and skin) by changing the way your immune system works. Tell your doctor if you have had any type of cancer.

Increased risk of major cardiovascular events such as heart attack, stroke, or death in people age 50+ with at least one heart disease risk factor when taking 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. This may be life-threatening. These types of blood clots occurred more often in people age 50+ with at least one heart disease risk factor when taking JAK inhibitors by mouth.

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

What has your journey with nonsegmental vitiligo looked like?

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My name is Alicia Roufs. My vitiligo journey started at three months old. My parents found spots in my diaper area. My mom thought it was diaper rash, tried to treat it with some ointment and it wasn't going away. So, took me to the doctor and we actually had a smart doctor at the time, and he knew it was vitiligo right away. “Keep her out of the sun, keep sunscreen on her,” and that’s all they really gave her. She did her best to try to help with sunburn and caking on the sunscreen as much as she could.

Late elementary school is when we finally went and saw a dermatologist about it, and he brought up a few different treatments. Of course, nothing was covered by insurance.

(DESCRIPTION)
Alicia’s photos from childhood montage across the screen, showing her as she grows and her vitiligo expands across her body.

(SPEECH)
The best treatment at that time was light therapy and coming into the office 3 times a week and that was the last thing I wanted to do.

It’s the stares. It’s the pointing, it’s the laughing that you can hear in the background. That, “What’s wrong with her? What’s wrong with her?” Like asking my sister, “What’s wrong with her skin? What’s wrong with her skin?” My sister would kind of pretend she didn’t know me or like would leave. It’s not just the individual with vitiligo–it’s the family that all experiences that and that’s a good example of it because my sister didn’t know how to deal with it and how to answer those questions, or what to say.

It wasn’t until I was later in life that I finally met people with vitiligo and grew a community. And once you found those people and connected, it’s when you kind of finally got whole with it, and, and felt like, okay, this–this makes sense now. For me, my vitiligo is a gift because I know I can help people that don’t have that same feeling I do. It’s something that deserves research. It deserves funding, it deserves recognition. It’s not cosmetic.

I’ve been on this journey a long time and not everybody is there, and that’s okay. I’m a loudmouth and I’m comfortable talking to people and I’m not scared to, to fight.

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ALICIA ROUFS
Vitiligo Advocate & Patient Spokesperson

(DISCLAIMER)
This video is sponsored by Incyte Corporation and Alicia has been compensated for her time. Content within this video is based on Alicia’s individual experience. Patient experience may vary depending on their insurance coverage, condition and financial circumstances.

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Why did you decide to treat your nonsegmental vitiligo?

(SPEECH)
When OPZELURA came out, you could use it at home, it’s just like putting lotion on your face or your hands and I thought, “Well, that seems pretty easy, and I don’t have to go anywhere.” Like, okay, let’s try this. The initial thought was I want to try this for the community. I’m an advocate for the community and I know there was going to be a lot of people that had questions about OPZELURA and is it effective? How do you get it? That was kind of the jumping off point of why I wanted to do it.

(DISCLAIMER)
For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Apply twice daily as directed by your healthcare provider. The use of Opzelura along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. Opzelura is for use on the skin only. Do not use in the eyes, mouth, or vagina.

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What was your experience getting access to Opzelura?

(SPEECH)
I tried to obtain OPZELURA when it kind of first came out. It had only been out in the market for a few months. I knew then I would probably have a more uphill battle at the time because it was new.

I had a great relationship with a healthcare provider, a member of our group who has vitiligo, works for a dermatology office and I actually sent her a text to say, “I'm thinking about getting this OPZELURA. Are you guys writing prescriptions right now?” She's like, “Oh, we're writing them like crazy right now, because people are excited.”

You have to stay on it. You have to be your own advocate and keep on people and keep the phone calls going because if you give up, then you're just back to square one.

I'm sure I cried when I got my first tube of OPZELURA to be totally honest with you. I’m sure I did. I'm glad I did what I did because now I've been able to help families through that process.

I don’t know anything about medicine. I don’t know any of the jargon. I know nothing. Like, insurance? Forget it.

I knew that I wanted it and I knew that I could get it.

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For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

(DISCLAIMER)
The use of Opzelura along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. Satisfactory patient response may require treatment with Opzelura for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be re-evaluated by the healthcare provider.

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What was your experience treating your nonsegmental vitiligo with Opzelura?

(SPEECH)
I never ever thought I would repigment. Like I thought, “We’ll see how it goes.”

With OPZELURA treatment, and really with any treatment, it's ongoing first of all. This isn't a cure, this is a treatment. And so it's something you have to treat every day, twice a day, really is what you’re supposed to do, as directed, twice a day on the areas that are affected.

You can do this at home and it's painless. I mean, I put it on my eyelids, I put it under my eyes. It doesn't hurt at all.

(DISCLAIMER)
Opzelura is not for everyone. Results may vary. Across two 6-month studies, 29.9% of those using Opzelura saw 75% improvement to vitiligo on the face compared with 7.5% and 12.9% of those using placebo. For topical use only. Do not use in your eyes, mouth, or vagina. Do not apply to more than 10% of your body surface area. Do not use more than one 60G tube per week.

(DESCRIPTION)
Alicia applies a thin layer of OPZELURA to the depigmented areas of her face.

(SPEECH)
It's not like heavy cake stuff. It's so easy to use and it works. I was lucky it worked fast, but it might not work that fast for everybody. It could take six months to a year. You have to be patient and you have to be persistent.

(DISCLAIMER)
Do not use more than one 60G tube per week. Results not typical. Individual results may vary. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be re-evaluated by the healthcare provider.

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What advice do you have for other people looking to manage their vitiligo?

(SPEECH)
If you're a person that has nonsegmental vitiligo, here are some things that you can try–and this is what I did. Work really closely with that healthcare provider. Get to know the staff really well because they're going to be your champions on this. You have to develop that relationship. Before you go into that appointment in the first place, have a list of questions available. Have your medical history available so the doctor knows maybe what things you've already tried if this isn't your first dermatology appointment. Have that ready and available so they know going forward, like, let's try this next.

You need to take advantage of those resources that are out there for you, like Opzelura On Trac.

But I think it always comes down to the same thing of being persistent and patient and being your own advocate and fighting for yourself. That's what you have to do over and over and over again. No matter what your path is.

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Visit www.opzeluraontrac.com for more information. Patients must meet eligibility criteria for this program.

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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:

• 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 at Opzelura.com.

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

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