For the short-term, non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) not well controlled on topical therapies in adults and children 12 and older without weakened immune systems or when those therapies are not recommended.
 

MANDY MOORE & ANNA

Watch as Anna, a 12-year-old with eczema, meets Mandy Moore who also lives with the condition. Anna recalls her experience dealing with relentless symptoms that affected her while cheerleading, playing basketball and even doing homework. She knew something had to change. Hear about the moment she realized it was time to find a treatment that helps improve her eczema. While Mandy isn't on OPZELURA, she's using her voice to encourage others to seek a treatment that's right for them.

Individual results may vary. OPZELURA is not for everyone.

Play video

MANDY AND ANNA VIDEO DESCRIPTIVE TRANSCRIPT

(DESCRIPTION)

Two comfortable chairs wait for their occupants in a sun-drenched basketball court.

(ON-SCREEN TEXT)

You’re about to meet two people with eczema:

(DESCRIPTION)

Tentative music enters along with a teenage girl, Anna, peering around a screen.

(ON-SCREEN TEXT)

Anna, who’s excited to tell her story.

And Mandy, who’s ready to listen.

(DESCRIPTION)

Mandy and Anna enter alongside uplifting music as they take the awaiting chairs after hugging in greeting.

MANDY:

Hi Anna.

MANDY:

I'm Mandy. It's so nice to finally meet you.

ANNA:

You too.

(ON-SCREEN TEXT)

This video is brought to you by Incyte.

MANDY:

Oh, this is so nice. Anna. How does it feel to be surrounded by cameras and eyeballs?

ANNA:

I mean, it feels pretty good, I guess. <laugh>

MANDY:

You never really get used to it. The excitement and feeling like -

ANNA:

Yes!

MANDY:

Action!

CREW:

A mark!

MANDY:

Walk me through a typical day for you. You wake up, you take the school bus?

(DESCRIPTION)

We run through a typical school day, passing lockers, taking tests, hearing the chatter of classmates and the ring of the bell.

ANNA:

I ride with my dad 'cause he teaches at my school. We get to school. Go to my classes—English, math, and history. After school—piano, cheerleading, and basketball.

MANDY:

Wow. You have a really packed schedule.

ANNA:

Yes.

MANDY:

I myself was a cheerleader—so much fun. Do you love it?

ANNA:

I love it. I can't jump in jeans. Okay. Oh God.

MANDY:

We have something else in common. We both suffer from mild to moderate eczema. Where do you have eczema?

ANNA:

My right hand, right here and right here.

MANDY:

I'm sure playing basketball and cheering where you have to clap a lot–

ANNA:

Like grabbing a pom-pom, it would sting really bad. And for basketball, every time I would dribble it, it would hit it and it would hurt. Before the games, I would just be like: hey, don't pass me the ball. Even writing my name, that would have to take breaks. Some days I would wake up and I'd just be like, mom, can I not go to school today? No, you have to go to school. We can wrap your hand. I just felt stuck.

(DESCRIPTION)

The music swells as Anna looks offscreen, blurring as if overfull of tears.

MANDY:

It's so frustrating. My eczema is mainly sort of localized around my eyes.

ANNA:

Mm-hmm.

MANDY:

It's itchy, it's uncomfortable. What were some of the things that you tried in order to find relief?

(DESCRIPTION)

The clatter of bottles and jars echo through the room as the music holds a pattern, waiting for something. Anna’s voice struggles with her.

ANNA:

So many things. Steroids, lotions. Sometimes we'd have to put socks over my hands and then wrap the socks to try to like keep the moisture on it. I just really lost hope for a long time.

MANDY:

Was there one particular incident that just...?

ANNA:

We were at a high school football game playing catch. I caught the football and my skin broke and it started bleeding. I went straight to my mom and said, I'm tired of it. I wanna find something that's gonna work. We actually talked to the dermatologist. She said, we've got this new drug you can try. It's called OPZELURA.

(DESCRIPTION)

The music swells, inviting hope into the frame as we watch Anna’s feet walk through the court, lining up and taking her shot.

NARRATOR:

OPZELURA is a treatment for mild to moderate eczema.

(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.

NARRATOR:

OPZELURA can lower your ability to fight infections, including TB or hepatitis B or C,

(ON-SCREEN TEXT)

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

(ON-SCREEN TEXT)

Your doctor should check for infections before and during treatment.

NARRATOR:

occurred with OPZELURA and people taking JAK inhibitors.

(ON-SCREEN TEXT)

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.

(ON-SCREEN TEXT)

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.

(DESCRIPTION)

Uplifting music enters with Mandy’s smile as she listens to Anna.

MANDY:

Let's talk about OPZELURA. I haven't tried it, but I heard it works really great for you.

ANNA:

Within a few days, the itchiness improved and within a few weeks the redness improved.

(ON-SCREEN TEXT)

OPZELURA will not work for everyone. 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.

MANDY:

Noticeably different?

ANNA:

And clearer skin.

MANDY:

Wow.

ANNA:

My best friend walks up to me and she's like, oh my gosh, you don't have your hand wrapped.

(ON-SCREEN TEXT)

Some people saw rapid itch improvement in as early as 3 or 4 days. Results may vary. See results at OPZELURA.com.

ANNA:

I finally picked up my pencil and started writing my name and I about started crying 'cause it didn't itch anymore.

(ON-SCREEN TEXT)

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

ANNA:

I'm just so happy that we found something that works and honestly, I'm just happy to do homework.

(DESCRIPTION)

Mandy’s laughter mingles with uplifting beats of hopeful music.

MANDY:

Haha I don't know if I believe you that you're happy to do homework. If someone who had eczema came to you, what would you tell them?

ANNA:

I would just tell them the truth and just tell 'em how well it worked for me.

(ON-SCREEN TEXT)

For topical use only. Do not use in your eyes, mouth, or vagina. Apply twice daily as directed.

MANDY:

I am sure you agree. It's incredibly important to talk to your dermatologist to figure out what your options are.

ANNA:

Mm-hmm. Ask somebody, ask for help.

(ON-SCREEN TEXT)

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.

MANDY:

You think you could show me a few things here on the basketball court?

ANNA:

Of course.

MANDY:

Okay. Let's do it.

ANNA:

I'm just so happy to be here and be able to tell my story. I feel like now I'm not the only one that has it since I get to share my story and maybe help others.

MANDY:

<laugh>

(DESCRIPTION)

Both music and scene fade out to the sounds of cheering and Mandy’s laughter as we complete this chapter of Anna’s journey.

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.

[END OF TRANSCRIPT]

 
IMPORTANT SAFETY INFORMATION AND INDICATION
IMPORTANT SAFETY INFORMATION AND INDICATION
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 or www.opzelura.pregnancy.incyte.com.
  • 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.