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Name super builds onto black screen while soft background music begins to play.
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EMILY
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Emily steps into the frame and speaks directly to the camera. The view is zoomed in, with only her shoulders and up showing.
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This video is brought to you by Incyte. Emily was compensated for her participation.
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Emily: Hi, my name is Emily and I'm from New Jersey. I’m married with three wonderful children.
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Camera zooms out to show a full-body view of Emily standing while talking to the camera on an empty, dark set.
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Emily: I work in a hospital performing high risk ultrasounds, and I have mild to moderate eczema.
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Bedroom set of a young girl comes in behind Emily and Emily sits on the end of the bed. The comforter is a pale shade of pink and a stuffed elephant sits next to the bed. Three panels behind the bed show delicate artwork and wallpaper with gold details. Stage crew members dressed in black can be seen setting up the scene and then exiting from view.
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Emily: My earliest memory of having eczema was when I was nine or 10 years old.
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Photo of Emily as a young girl sitting on her mother’s lap while in a kiddy pool outside shows on screen as Emily continues to share her story.
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Emily: I remember playing outside and…
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View switches back to Emily sitting in her childhood bedroom. Camera alternates between a zoomed-in view of her head and shoulders and a panned-out view of her full body.
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Emily: …getting this uncontrollable itch on the arch of my foot. I was scratching so hard, but nothing was making the itch go away. I would wake up in the middle of the night because the itching was so intense and I couldn't sleep through it. At that point, my grandmother was like, "We need to take you to the dermatologist," and that's when I was diagnosed with mild to moderate eczema.
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Emily stands up from the bed and walks off the scene of her childhood bedroom to one of a baby’s nursery.
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Emily: As I got older, my eczema began to change. In my 20s, my husband and…
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Crew members dressed in black can be seen moving a crib into the scene. The camera focuses on a crew member placing a white, fluffy teddy bear on the area rug of the baby’s nursery. Emily stands in front of the crib, positioned in front of a window. An armchair and floor lamp complete the room. Camera alternates between full-screen and zoomed-in view of Emily as she talks.
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Emily: …I started IVF and I noticed my eczema becoming worse. It was keeping me up at night from scratching, and that's when I decided to go back to the dermatologist to see if maybe there was something more I could be doing. My experience at the dermatologist was more steroids. Maybe it was time to start an injectable, but an injectable wasn't right for me.
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Photo of Emily smiling with her baby sleeping on her chest shows on screen. View switches back to Emily standing in the nursery.
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Emily: The itch was just so incredible that even my sheets touching my skin just made me scratch more.
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Crew members in black begin removing furniture from the baby’s nursery.
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Emily: A standout moment for me living with eczema happened on my daughter's soccer field.
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Emily exits the scene of the nursery, with crew members setting the scene for a soccer field. Emily crosses the field to sit on a metal bench along the side of the field.
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Emily: I was at my daughter Samantha's soccer game and she was finally participating. She went to score her first goal and she made it. I was so proud I ran onto the field. When I went to high five her, one of her little teammates said, "Ew, what's on your hand?"
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Photo of the palms of Emily’s hand with eczema irritation shows on screen. View returns to Emily sitting on the bench.
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Emily: It completely stopped the moment and I had to kneel down and explain what my eczema was on my hand. We had waited for this moment for so long and I wanted to celebrate her, and instead it took the whole important moment for my daughter completely away from her. I think eczema took a lot of special moments away from me as a mom. I clearly remember going to cross the street and my daughter wouldn't hold my hand. I realized it was from my eczema because when I went to reach for her, even when we were just watching a movie, she said, "I don't want to touch that." I was devastated. All I want to do is snuggle with my children, and now they were trying to stay away from my eczema.
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Emily stands up from the bench and begins to walk off the field. She exits the scene of the soccer field and enters the scene of a hospital room.
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Emily: The turning point in my journey was when my co-workers at the hospital started to notice my eczema. They even started to try to help me.
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Emily stands in the center of the hospital room, speaking to the camera. Views alternate between zoomed-in and full body.
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Emily: One day, one of the physicians came in and said, "Did you hear about a cream called OPZELURA that is steroid-free? You really have got to try it."
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OPZELURA® (ruxolitinib) cream 1.5% is a treatment for mild to moderate eczema. For short-term, non-continuous treatment in people 12 and older without weakened immune systems and not well controlled on topical Rx therapies or when therapies are not recommended.
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Emily: I kind of brushed it off because I felt like I had hit a brick wall and this was something that I was just going to have to live with.
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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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The camera focuses on an armchair in the hospital room with a pillow and blanket on it, then zooms in on Emily’s waist with her thumb hanging from the front pocket of her jeans.
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Narrator: OPZELURA can lower your ability to fight infections. Tell your doctor if you have or had an infection, TB, hepatitis B or C, blood clots in your legs or lungs, heart attack, stroke, cancer, high cholesterol, are a smoker, or pregnant.
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OPZELURA can lower your ability to fight infections.
Tell your doctor if you have or had an infection, TB, hepatitis B or C, blood clots in your legs or lungs, heart attack, stroke, cancer, high cholesterol, are a smoker, or pregnant.
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The camera focuses on a zoomed-in view of a soccer ball on a field with a car wheel in the background.
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Narrator: OPZELURA may cause serious lung infections, certain cancers, immune system problems, blood clots, and low blood cell counts. Major cardiovascular events or death occurred in those 50+ taking oral JAK inhibitors.
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OPZELURA may cause serious lung infections, certain cancers, immune system problems, blood clots, and low blood cell counts. Major cardiovascular events or death occurred in those 50+ taking oral JAK inhibitors.
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The camera focuses on the area between the scenes of Emily’s childhood bedroom and the baby’s nursery.
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Narrator: The most common side effect was the common cold.
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The most common side effect was the common cold.
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Emily returns to the frame, speaking to the camera from the hospital room.
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Emily: Finally, I did. I called the dermatologist. I got right in,...
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For topical use only. Do not use in your eyes, mouth, or vagina. Apply twice daily as directed.
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Emily: …and we decided that OPZELURA was the right treatment for me. I really like that I don't have to wean off of it because I'm a busy mom…
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Apply a thin layer of OPZELURA cream twice daily to affected areas. Use OPZELURA on up to 20% of your body as directed by your healthcare provider.
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Emily: …and I can just stop the cream. As soon as I have a flare up, I can start it again. I just apply it once in the morning, once at night. It's really simple.
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Stop using OPZELURA when your signs and symptoms of atopic dermatitis, such as itching, rash, and redness go away, or as directed by your healthcare provider. Do not use more than one 60-gram tube per week.
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Emily: The moment I realized OPZELURA was working was around day four, and even my children started to notice. My husband noticed, coworkers noticed I wasn't scratching.
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Individual results may vary. In a medical study of mild to moderate atopic dermatitis, 54% of patients had clear to almost clear skin at 8 weeks and 52% of patients had a significant reduction in their itch, compared to 15% of patients who used a cream that did not contain medication.
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Emily: I was paying attention. I was present because I wasn't thinking about that itch in the back of my mind. Every morning, my daughters would check…
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Tell your healthcare provider if your symptoms do not improve within 8 weeks of treatment. Results may vary.
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Emily: …and see the progress and say, "Mommy, look, it's going away," and the best moment of all…
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Before starting OPZELURA, tell your doctor if you have an infection, are being treated for one, have TB or have been in close contact with someone with TB; or had Hepatitis B or C.
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Emily: …is when we curled up on the couch and watched a movie and they wanted to hold my hand again.
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Photo of Emily and her 3 daughters sitting closely at an airport gate shows on screen, followed by another photo of Emily and one of her daughters holding hands. Then, the view returns to Emily speaking in the hospital room.
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Emily: My advice to anyone with eczema is to not give up. You need to call your dermatologist and find out if OPZELURA is right for you.
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Your doctor should check for infections before and during treatment. Tell your doctor if you had blood clots in your legs or lungs. OPZELURA may cause low platelets, low red and white blood cell counts. Keep watching for Important Safety Information.
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Screen fills to a dark purple background with the OPZELURA logo and important safety information and indication scrolling.
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Narrator:
INDICATION AND USAGE
OPZELURA is a prescription medicine used on the skin (topical) for the short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised adults and children 12 years of age and older whose disease is not well controlled with topical prescription therapies or when those therapies are not recommended.
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 atopic dermatitis.
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 atopic dermatitis include: common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea).
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.
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