DESCRIPTIVE TRANSCRIPT RACHAEL VIDEO
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Rachael sits in a comfortable chair holding a video clapboard, looking around at the video crew.
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This video is brought to you by Incyte.
RACHAEL:
Take two.
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Anna, Rachael’s daughter, turns and smiles at us before we see Rachael, warm music introducing us to the duo.
RACHAEL:
Anna is, she is kind. She is outgoing, she's funny, a little fierce at times.
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Rachael
Anna’s Mom
ANNA:
Try not to like, touch anything or knock anything over.
RACHAEL:
She's just a good, normal kid. Anna has mild to moderate eczema on her hands and the creases of her elbows. Yeah, she has itchiness, sometimes lesions, redness.
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Anna goes through a series of activities that make up her life: basketball, cheerleading, piano. Rachael passes her a drink off the basketball court and wraps Anna's hands.
RACHAEL:
It's impacted her in a big way, um, especially with the, the flare ups on her hands. Think about how much you do with your hands in just your day to day. Certain days of the week she has cheer. Certain days of the week she has piano, playing basketball. She would have to stop and take breaks. It was just challenging for her.
RACHAEL:
We started wrapping her hands. She would come home from school and say: mom, my friends think that it's contagious. It's just something a 12 year old shouldn't really have to answer to.
(DESCRIPTION)
We drift by a countless number of ointment jars and lotion bottles. The music begins to build as Rachael speaks.
RACHAEL:
So looking, searching—lotions, creams, other prescription medications, different clothing—just didn't seem to help. One of the pivotal moments was when Anna and I attended a high school football game. She had been down throwing the football back and forth, and she walked up to me and said, can you look at my hands? The lesions were worse. She said, mom, we've gotta do something.
(DESCRIPTION)
Rachael’s fidgets with her hands, uncomfortable in reminiscing.
RACHAEL:
From a parent standpoint, I'm not able to immediately fix it for Anna—I'm gonna start crying. Hold on. I called our local dermatologist and he suggested that we try OPZELURA.
(DESCRIPTION)
Anna comes over to whisper in her mother’s ear, getting some head pats, music rising with her entrance.
NARRATOR:
OPZELURA is a treatment for mild to moderate eczema.
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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.
NARRATOR:
OPZELURA can lower your ability to fight infections, including TB or hepatitis B or C,
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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.
NARRATOR:
serious lung infections, skin cancer, blood clots, and low blood cell counts
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Your doctor should check for infections before and during treatment.
NARRATOR:
occurred with OPZELURA and people taking JAK inhibitors.
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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.
NARRATOR:
Serious infections, increased risk of death, lymphoma, other cancers, and major cardiovascular events have occurred. The most common side effect was the common cold.
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OPZELURA is a topical JAK inhibitor. People 50 and older with at least 1 heart disease risk factor have an increased risk of heart attack, stroke, blood clots, and death while taking JAK inhibitors by mouth.
RACHAEL:
You know, I just naturally had doubts just because we've tried so many other things in the past. Here's another cream. Um, we're gonna use this and it's not gonna work.
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OPZELURA will not work for everyone. In a medical study of mild to moderate atopic dermatitis, 54% of patients had clear or 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.
RACHAEL:
After Anna started OPZELURA, we noticed that she was not as bothered by her symptoms—less itchiness, less redness, and certainly less inflammation.
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Some people saw rapid itch improvement in as early as 3 or 4 days. Results may vary. See results at Opzelura.com.
RACHAEL:
As a mom, watching Anna play basketball now and not be as bothered by her eczema symptoms, it's very special and emotional for me.
(ON-SCREEN TEXT)
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.
(DESCRIPTION)
Rachael smiles as Anna scores a shot on the basketball court, clapping. The duo silently share an animated conversation.
RACHAEL:
What Anna's gone through for the last, you know, 10 years, I mean it's been majority of her childhood
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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.
RACHAEL:
—makes me tear up thinking about it. Advice I would give to other parents seeking treatment for their child.
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If you are using OPZELURA for atopic dermatitis, 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. Tell your healthcare provider if your symptoms do not improve within 8 weeks of treatment.
RACHAEL:
Number one, be patient. Number two, talk with your dermatologist about your different options. Everybody's experience is their own. Being able to tell her story and to know that she's not alone. There's help, there's treatment. I-I'm really kind of at a loss for words.
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For topical use only. Do not use in your eyes, mouth, or vagina. Apply twice daily as directed.
(DESCRIPTION)
Anna plays piano, jumps in her cheer outfit, and coaches Rachael on how to shoot a hoop as encouraging music takes us through these snapshots.
RACHAEL:
Impressed, proud. I give a whole lot to Anna, but at the same time, you can also learn from your own children. Anna teaches me a lot too.
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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