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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.
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GETTING STARTED WITH OPZELURA

From important dosing information to some helpful tips, Andrea, a physician assistant, has us covered on the road to
getting started.

Andrea has been compensated for her time.

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(TITLE SLIDE)

Getting Started with OPZELURA

(ON-SCREEN TEXT)

OPZELURA (ruxolitinib) cream 1.5%

(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)

A woman smiles at us from a comfortable chair as the lights rise, upbeat music lowering as she begins to speak.

(SPEECH)

ANDREA NGUYEN: I'm Andrea Nguyen, a dermatology physician assistant.

(ON-SCREEN TEXT)

Andrea Nguyen

Dermatology Physician Assistant

(DISCLAIMER)

This video is sponsored by Incyte Corporation. Andrea Nguyen has been compensated for her time.

(SPEECH)

Let's talk about how to get started with OPZELURA for appropriate patients with mild to moderate eczema. First and foremost, make sure you're using OPZELURA exactly how your healthcare provider prescribed it.

(DISCLAIMER)

For the topical treatment of mild to moderate eczema in patients aged 12 and older without weakened immune systems.

(SPEECH)

Today, I'm going to share a few things you should keep in mind when you're getting started. OPZELURA isn't a steroid, pill, or injection. It's a topical treatment for mild to moderate eczema in patients 12 years of age and older without weakened immune systems.

(DISCLAIMER)

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

(DESCRIPTION)

Andrea watches as a patient itches her elbow, frustrated, before the patient applies OPZELURA.

(SPEECH)

OPZELURA is used twice daily as needed for eczema flare-ups.

(ON-SCREEN TEXT)

Twice daily

(SPEECH)

Just make sure you do not use more than one 60 gram tube each week. It's a good idea to make it part of your morning and evening routine. It may be helpful to set up phone reminders until you get in the habit.

(SPEECH)

It's important to understand when you should start using OPZELURA and when you should stop.

(ON-SCREEN TEXT)

When to start.

When to stop.

(DISCLAIMER)

Stop using OPZELURA when signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your healthcare provider.

(DESCRIPTION)

The patient applies a thin layer of OPZELURA to her eczema flareup near her eye.

(SPEECH)

You should use OPZELURA twice daily, whenever you're experiencing eczema symptoms like red, irritated skin or itchiness.

(ON-SCREEN TEXT)

When to use OPZELURA

(DISCLAIMER)

For topical use only. Do not use in your eyes, mouth, or vagina. Apply twice daily as directed. Talk with your healthcare provider if your eczema does not improve after 8 weeks of using OPZELURA.

(SPEECH)

Apply OPZELURA to areas of the skin where you have eczema, but use a thin layer like this.

(ON-SCREEN TEXT)

A thin layer

(DISCLAIMER)

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

(SPEECH)

OPZELURA can even be applied to sensitive areas like the skin around the eyes, mouth, or groin.

(ON-SCREEN TEXT)

Sensitive areas

(DISCLAIMER)

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

(DESCRIPTION)

The patient applies OPZELURA to flare ups on her elbow, wrist, and calf.

(SPEECH)

You can apply that thin layer on up to 20% of your body's surface.

(ON-SCREEN TEXT)

Up to 20% BSA

(DISCLAIMER)

Do not use more than one 60 gram tube per week.

(DESCRIPTION)

Andrea holds up her hand with the fingers held together, displaying a handprint.

(SPEECH)

But how can you measure that 20%? For reference, one of your handprints is about 1% of your body's surface area.

(ON-SCREEN TEXT)

20 of your handprints

(SPEECH)

When your symptoms like itchiness, rash, or redness go away, stop using OPZELURA.

(ON-SCREEN TEXT)

You can stop

(DESCRIPTION)

The patient looks at her facial eczema critically before applying some OPZELURA to her elbow flare up.

(SPEECH)

Talk with your healthcare provider if your eczema does not improve after 8 weeks of using OPZELURA.

(DISCLAIMER)

Talk to your healthcare provider if symptoms do not improve within 8 weeks.

(SPEECH)

Remember, when you're done applying, be sure to wash your hands - unless that's where you've just applied your treatment.

(ON-SCREEN TEXT)

Wash up

(TITLE SLIDE)

Refills

(SPEECH)

And one more thing to keep in mind: flare-ups are a regular part of eczema, so be sure to keep a refill handy just in case. Your OPZELURA box should be labeled with important information about when you'll need to order a refill. Snap a photo just in case you throw it away or lose it.

(DISCLAIMER)

Do not use more than one 60 gram tube per week.

(SPEECH)

Better yet, talk to your pharmacist about keeping track of your refills.

(ON-SCREEN TEXT)

Keeping track

(SPEECH)

If you follow your healthcare provider's instructions and remember these tips, you can be on your way to relief with OPZELURA. Imagine that.

(ON-SCREEN TEXT)

All set.

(DISCLAIMER)

Results may vary.

(SPEECH)

Please continue watching for Important Safety Information.

(ON-SCREEN TEXT)

Please keep watching to view the full Important Safety Information next.

(SPEECH)

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.

OPZELURA, the OPZELURA logo, Incyte, and the Incyte logo are registered trademarks of Incyte.

© 2024, Incyte.  MAT-OPZ-02003  04/24

[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.