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Accessing OPZELURA® (ruxolitinib) Cream 1.5%:
A Discussion Between a Nonsegmental Vitiligo Patient and a Healthcare Professional

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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 is your connection to the vitiligo community?

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Two women, Angela and Alicia, sit on a couch in a welcoming living room. Alicia has some vitiligo depigmentation on her hands, neck and face.

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ALICIA: I'm Alicia Roufs. I am a person with vitiligo. I've had it since I was three months old, so 46 years now. And I run support groups here in Minnesota.

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ALICIA ROUFS
Vitiligo Advocate & Patient Spokesperson

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This video is sponsored by Incyte Corporation. Alicia and Angela have been compensated for their time.

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ANGELA: My name is Angela Lee and I am a biologic access coordinator. And I've been in dermatology for about 16 years now. I want to make sure that patients have access to the medication that they need.

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ANGELA LEE
Biologic Access Coordinator

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ANGELA: How has your life been with vitiligo? Tell me a little bit about that.

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Angela and Alicia look through pictures of Angela with her vitiligo prominently shown from various stages of her life together.

ALICIA: Growing up was tough. I am the only person in my family with vitiligo. I didn't meet anybody with vitiligo until I was 16. So, it was kind of an isolating feeling of no one to relate to, no one to talk to, no one to, um, understand what I was going through.

ANGELA: There are a lot of patients that are suffering with this autoimmune disease. It's not just something that's cosmetic. There's so many people that are just not educated on vitiligo. So when they see someone with vitiligo, they think it's contagious. It's important for people to know, hey it's not contagious.

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Why did you want to treat your nonsegmental vitiligo with Opzelura and what was your experience accessing Opzelura?

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ALICIA: When I started the OPZELURA journey, it was kind of to help educate our community. I kind of wanted to test it out and see what would happen. I wanted to try it on myself, see what it was like, see if the repigmentation process really worked. And also I wanted to see what it took to get the drug. And that was kind of the bigger thing. Like, okay, it’s out there now, it’s FDA-approved. Granted, I tried not too far along after it was officially approved, so I knew there was going to be some hurdles.

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

(DISCLAIMER)
The use of Opzelura along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. 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.

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What are some common challenges in gaining access to Opzelura and what can patients and healthcare providers do to help the process?

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ANGELA: Programs are always changing, insurance formularies are always changing. So, we have to constantly educate ourselves, reach out to peers, because some of the patients, they can get the medication a lot quicker, some of them it takes a little more battling it out. You know, with those roadblocks, and I’m just kind of there to clear the way. I just always want to make sure that everything’s thoroughly documented prior to submitting this information to the insurance. So, this is trying to collect as much history as possible.

ALICIA: It’s a lot. It can be very, very overwhelming. But again, it goes down to being patient and persistent.

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What is your perspective on commercially insured patients being covered for Opzelura?

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ANGELA: OPZELURA actually has amazing coverage. So, it’s available for over 80% of commercially insured patients nationwide. And if it’s commercially insured and it’s covered, they can pay as little as $0.

(DISCLAIMER)
Requirements for coverage may differ by insurance plan. Patients can pay as little as $0 if they are eligible for the Opzelura Copay Savings Program. Eligibility required. For use only with commercial prescription insurance. The card may not be used if the patient is enrolled in a government-funded prescription insurance program or if they pay cash for their prescription. Individual out-of-pocket cost may vary. Maximum benefits per tube and per calendar year apply. Must be used for an FDA-approved indication. Review additional Terms and Conditions by visiting opzelura.com and selecting the patient’s condition.

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What advice do you have for people with nonsegmental vitiligo who are seeking access to treatment with Opzelura?

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ALICIA: We encourage people to talk to their doctor's office, to work closely with their healthcare providers, with the staff. They're there to help you. And if you have somebody like yourself that works closely with you, then it makes that journey so much easier. But you have to be persistent. You have to be patient, and you have to be your own advocate.

ANGELA: I am their resource. I am their point of contact that's going to advocate for them. And I'm going to be the person that is going to help them along that way, and I just have to educate them as well just to advocate for themselves. However, I always direct them to OpzeluraOnTrac.com because that is an additional resource. There are photos on there, before and afters, which is amazing because it can give them realistic expectations.

ALICIA: I use that resource a lot, not just their website, which is super helpful. And the information you can provide your healthcare provider.

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

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ANGELA: So, Alicia, how did you feel when you were able to gain access to Opzelura?

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ALICIA: When I finally got the tube, it was like, “Ahhh,” it was wonderful. because it’s like, one, I never ever thought I would do treatment for vitiligo. I just never thought that was in the cards.

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Alicia carefully applies a thin layer of OPZELURA to the depigmented skin on her face while looking in the mirror.

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ALICIA: It was something I could do at home and it was so easy and it just came to my home, and it was so exciting and I was really excited to try it.

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What has your experience been since using Opzelura for the treatment of nonsegmental vitiligo?

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ALICIA: As someone who has had vitiligo forever, I have learned to be very comfortable in my skin. But now that I'm into it, and I've done this for over a year now, it's like, wow. I did not expect it to work on somebody who has never done anything before. And to have it almost completely fill in where I've treated it, it’s been amazing.

(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. Apply twice daily as directed. Individual results may vary. Results not typical.

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What have you learned from managing your nonsegmental vitiligo and what advice would you share with other people living with the condition?

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ALICIA: Do a little research. The doctor is there to help you, and so you need to make sure you're asking for what you want and what you need. The dermatologists have a very short amount of time to talk to you. So as much questions as you can, prepare ahead of time, write it down if it helps you remember it, but rely on also the staff and the nurses too, because a lot of times, they're the ones doing all the work behind the scenes. When people are brand new to an office and they don't know anybody – yeah, you kind of have to develop that rapport. And if you're scared, bring somebody with you too. If maybe you don't have the loudest voice, bring your mama who's gonna fight for you.

ANGELA: Yes, Mom's gonna fight for you.

ALICIA: Yeah, you know, like, bring somebody that's gonna fight for you. You know your body, you know yourself. You are your strongest advocate.

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Visit www.opzeluraontrac.com for more information.

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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.

© 2024, Incyte. MAT-OPZ-02058 06/24