(DESCRIPTION)
Two microphones wait on a table as upbeat music enters.
(TITLE SLIDE)
OPZELURA (ruxolitinib) cream 1.5%
On Air
(ON-SCREEN TEXT)
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.
Important Safety Information will be discussed in more detail, later in this video.
(DESCRIPTION)
Sam swipes through images of her repigmentation journey on her phone as upbeat music fades out.
(SPEECH)
SAM: I didn't think there would ever be a treatment that worked for me. So it's just really exciting to kinda start this chapter.
(ON-SCREEN TEXT)
A sign on the wall that reads 'OPZELURA ON AIR' lights up in white.
(DESCRIPTION)
Drumbeat kicks off upbeat music. Sam and Sam Nicolini enter. Sam points out the ‘Opzelura On Air’ sign on the wall.
(SPEECH)
SAM: Do you see this?
SAM NICOLINI: I love this.
SAM: It's set up for us?
SAM NICOLINI: Yeah. Oh my god, we have to plug this in.
Plugged in?
SAM: Yeah.
SAM NICOLINI: All right.
SAM: Hi, I'm Sam and I have nonsegmental vitiligo, and I'm using OPZELURA.
(ON-SCREEN TEXT)
Sam
Actual OPZELURA patient
(SPEECH)
SAM NICOLINI: Hi, I'm Sam, and I'm a dermatology physician assistant. And I treat nonsegmental vitiligo with OPZELURA.
(ON-SCREEN TEXT)
Sam Nicolini
Certified Dermatology Physician’s Assistant (PA)
(DISCLAIMER)
For the topical treatment of nonsegmental vitiligo in patients 12 and older. This video is sponsored by Incyte Corporation. Sam and Sam were compensated for their time.
(SPEECH)
SAM: But she's not my healthcare provider.
SAM NICOLINI: We're best friends.
SAM: And this is our OPZELURA moment on air.
(DESCRIPTION)
Soft guitar strumming brings a sense of nostalgia.
(TITLE SLIDE)
On Air
My Moment with Sam & Sam
(SPEECH)
SAM NICOLINI: What can you tell us about our friendship?
SAM: I guess our friendship just started because you had the same name as me and lived across the street and I had no friends when I moved there.
SAM NICOLINI: It was that easy.
SAM: So I figured we needed to be. But since then, I mean, we've been through so much together.
SAM NICOLINI: Everything.
(DESCRIPTION)
Childhood pictures of the two friends are laid out on the table. Sam Nicolini takes one—a picture of them smiling and holding a birthday cake.
(SPEECH)
SAM NICOLINI: This is one of our many birthdays when you went brunette.
SAM: Yeah, that was a bad idea.
(DESCRIPTION)
Sam Nicolini picks up a photo of them wearing matching Halloween outfits and points out the vitiligo on Sam’s knees.
(SPEECH)
SAM NICOLINI: Our matching holiday halloween outfits. Aw, look at your knees.
SAM: I know. It was like it spread so much.
SAM NICOLINI: I don't remember it like that.
(DESCRIPTION)
Sam picks up a portrait of herself when her vitiligo was visible on her face.
(SPEECH)
SAM: Yeah, this is like when I first started noticing the vitiligo on my face.
SAM NICOLINI: Oh yeah, I can see it right there.
SAM: Yeah.
SAM NICOLINI: So when it started spreading, what was that like, especially being, you know, in like junior high?
(ON-SCREEN TEXT)
Growing up with nonsegmental vitiligo
(SPEECH)
SAM: I remember being annoyed about it, but I knew that it was something I was going to have to deal with. And my expectations were kind of set when I was in second grade that there wasn't anything that can really be done about it.
SAM NICOLINI: Sure, yeah.
(DESCRIPTION)
A photo of Sam smiling with her family, vitiligo noticeable on her face, wrist, and knees.
(SPEECH)
SAM: It's not so much that it really bothered me. I think it's just a condition that clearly separates you from other people.
SAM NICOLINI: For sure.
SAM: So when you're growing up and stuff, it's something that, you know, you're not like everybody else because of it.
SAM NICOLINI: Yeah, yeah.
SAM: So you want to kind of do something so that you feel like you—you feel like everybody else.
SAM NICOLINI: Yeah, maybe you just don't feel like being asked about it that day. You know, you're like I don't want to talk about why, like, I have spots on my face. You know what I mean?
(DESCRIPTION)
Close-up photos of Sam where vitiligo is visible on her face.
(SPEECH)
SAM: Yeah, yeah.
(DESCRIPTION)
Uplifting music enters.
(SPEECH)
SAM NICOLINI: Yeah. So you've always seemed pretty comfortable with your nonsegmental vitiligo. So why treat it?
(ON-SCREEN TEXT)
Treating nonsegmental vitiligo
(DISCLAIMER)
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.
(SPEECH)
SAM: So I grew up with it. I kind of only remember having it. So I was really excited about an option to see what it would be like without it being so noticeable and kinda like living that way. And so it just is something that I wanted to try.
SAM NICOLINI: At work, we treat a lot of patients with vitiligo. Sometimes they come in for that because they've just noticed it and it's very distressing, and sometimes you just notice it when they're there for a whole skin check. So you're checking everything and you're like, oh, did you know you have vitiligo here and there's treatments for that?
With using OPZELURA cream, we've had great results for some patients with nonsegmental vitiligo and I knew that it would be a great option for you. So I was really excited for you to see your dermatologist and get started with it.
(DISCLAIMER)
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.
(DESCRIPTION)
Sam walks towards a mirror in her bathroom and shows how she applies a thin layer of OPZELURA near her eye. Then, she washes her hands.
(TITLE SLIDE)
Applying OPZELURA Twice Daily
(SPEECH)
SAM: So as part of my morning routine after I wash my face, I'll apply OPZELURA. I like to keep it where it's easily accessible so I'm able to fit it into my daily routine. And I take a thin layer like this and will apply it to all the spots where I have vitiligo. So around my forehead, and I'll extend it down my neck, and around my eyes. I'm careful not to get any in my eyes. And then I'll wash my hands.
(DISCLAIMER)
For topical use only. Do not use in your eyes, mouth, or vagina. Apply twice daily as directed by your healthcare provider. Do not apply to more than 10% of your total body surface area. Do not use more than one 60 gram tube per week.
(SPEECH)
SAM NICOLINI: When did you or someone else first notice pigment was starting to return? And was there like a particular moment?
(ON-SCREEN TEXT)
Seeing the results
(SPEECH)
SAM: My husband probably pointed it out.
(DISCLAIMER)
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.
(DESCRIPTION)
A close-up photo of Sam’s facial repigmentation.
(SPEECH)
SAM: You could see on my chin, like almost like little dots of color coming back.
(ON-SCREEN TEXT)
10 months of treatment
(DISCLAIMER)
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. Patient used OPZELURA alone for treatment of vitiligo on her face and neck.
(SPEECH)
SAM NICOLINI: Did you track your progress in any way, like taking pictures, or?
SAM: Yeah, I probably took pictures almost daily in the beginning, but I knew that it wasn't going to show up right away. But I have some for you.
(DISCLAIMER)
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. Patient used OPZELURA alone for treatment of vitiligo on her face and neck.
(DESCRIPTION)
Sam swipes through her repigmentation progress photos on her phone.
(SPEECH)
SAM: This is probably like week, week one when I first started.
SAM NICOLINI: Oh my gosh, yup.
SAM: You can see my whole face is kind of covered and down my neck.
(ON-SCREEN TEXT)
Before treatment
(DISCLAIMER)
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. Patient used OPZELURA alone for treatment of vitiligo on her face and neck.
(SPEECH)
SAM NICOLINI: Yup. Yeah, you can already see—
SAM: And then you can see, kind of, like the pigment filling in.
SAM NICOLINI: Yup, and the cheek area.
(ON-SCREEN TEXT)
2 months of treatment
(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. Patient used OPZELURA alone for treatment of vitiligo on her face and neck. Repigmentation may continue beyond 6 months. If meaningful repigmentation is not achieved after 6 months, please consult your healthcare provider.
(SPEECH)
SAM: Around my eyes and on my chin.
(ON-SCREEN TEXT)
8 months of treatment
(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. Patient used OPZELURA alone for treatment of vitiligo on her face and neck. Repigmentation may continue beyond 6 months. If meaningful repigmentation is not achieved after 6 months, please consult your healthcare provider.
(SPEECH)
And then most of my cheeks had already come back and my neck started filling in a little bit more.
(ON-SCREEN TEXT)
10 months of treatment
(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. Patient used OPZELURA alone for treatment of vitiligo on her face and neck. Repigmentation may continue beyond 6 months. If meaningful repigmentation is not achieved after 6 months, please consult your healthcare provider.
(SPEECH)
You can see like that whole side.
(ON-SCREEN TEXT)
12 months of treatment
(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. Patient used OPZELURA alone for treatment of vitiligo on her face and neck. Repigmentation may continue beyond 6 months. If meaningful repigmentation is not achieved after 6 months, please consult your healthcare provider.
(ON-SCREEN TEXT)
Before treatment
12 months of treatment
(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. Patient used OPZELURA alone for treatment of vitiligo on her face and neck. Repigmentation may continue beyond 6 months. If meaningful repigmentation is not achieved after 6 months, please consult your healthcare provider.
(SPEECH)
Again, like I didn't think there would ever be a treatment that worked for me, so.
(SPEECH)
SAM NICOLINI: What has motivated you to stay on treatment?
SAM: The results have helped me stay motivated and I don't even really think about it anymore. It's not like a chore. I have to do it. It's just part of—
SAM NICOLINI: It's just like part of your routine?
SAM: —what I do. And I have my check-ins with my derm every couple months and you know, she's excited about it too. So I think it's just kind of, it's easy for me to stay on.
(DISCLAIMER)
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.
(SPEECH)
You know, I've lived my whole life having the condition and thinking that it was only going to spread. And since I've been using OPZELURA I've started to see this repigmentation
(DISCLAIMER)
If you don’t find repigmentation meaningful at 6 months, talk to your healthcare provider.
(SPEECH)
and it's just really exciting to kinda start this chapter.
(DISCLAIMER)
Results may vary.
(SPEECH AND ON-SCREEN TEXT)
NARRATOR:
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:
- 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 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.
OPZELURA, the OPZELURA logo, Incyte and the Incyte logo are registered trademarks of Incyte.
© 2024, Incyte. MAT-OPZ-02103 04/24
