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Accessing OPZELURA® (ruxolitinib) Cream 1.5%:
How Healthcare Professionals Can Support 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 is your experience helping patients gain access to medications?

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A woman sits in her warmly dressed office, ready to help patients.

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My name is Angela Lee and I am a biologic access coordinator. I've been in the field of dermatology for 16 years now, and my role is to help patients gain access to the medication that they need.

Insurance companies set requirements for patients to gain access to medications. I am with them, guiding them through and clearing out roadblocks that there might be to access. And I'm the person that's going to advocate for them and I will educate them and teach them how to advocate for themselves as well.

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ANGELA LEE
Biologic Access Coordinator

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This video is sponsored by Incyte Corporation and Angela has been compensated for her time.

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What advice do you have for someone seeking to treat their nonsegmental vitiligo with Opzelura?

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You want to make sure that you work very closely with your healthcare provider and leverage all of the resources that are available. Make sure that you are a good historian by providing all of your tried and failed therapies. Photos can be helpful and it's okay if you don't have them.

The path is not easy for all patients to gain access to Opzelura. For some it might be quick, for others it might take a little more time. But, don't worry, there are many resources that are available for you.

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For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age or older. 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. Visit www.opzeluraontrac.com for more information. Patients must meet eligibility criteria for this program. The use of Opzelura along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. Individual out-of-pocket cost may vary. Maximum benefits per tube and per calendar year apply. Must be used for an FDA-approved indication. Additional Terms and Conditions apply.

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What out-of-pocket savings are available for eligible patients?

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The out-of-pocket savings for commercially insured eligible patients, they can pay as little as $0 for Opzelura.

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Savings available with the Opzelura Copay Savings Program.

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What support is available for commercially insured patients who are denied coverage by their health plan?

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If a patient is denied coverage for Opzelura, there are other resources that are available. The program is called Opzelura On Trac.

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

What advice do you have for patients working with their healthcare providers to navigate prior authorizations and gain access to Opzelura?

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My advice for any healthcare provider that's trying to help their patient gain access to Opzelura is it's important to know that you need to have a single point of contact in the office. They will know what the patient needs to do from start to finish.

They will know what is needed in the chart notes in order to help gain access to the medication. Your documentation should tell a story, so whoever's reading that is feeling what the patient is feeling, because I think that's very important. They will also know a lot of the insurance criteria right from the beginning.

Make sure that you are passionate about helping patients gain access to the medication. Putting yourselves in their shoes really goes a long way.

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For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 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.

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How do patients respond when you tell them they have gained access to Opzelura?

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The reaction that I always get when I tell patients that they've been approved is they're just so grateful and they really appreciate all of the hard work and dedication.

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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.

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