About Dupixent

HELP HEAL YOUR SKIN FROM WITHIN

Learn how DUPIXENT can help you stay one step ahead of your uncontrolled moderate-to-severe eczema (atopic dermatitis).

DUPIXENT, a biologic, is a specialty medicine made inside living cells. It is processed in the body differently than oral medicines (pills) or steroids. In order to be effective and work in the body properly, most biologics are injectable medicines due to their size and the unique way they are made. DUPIXENT works by targeting an underlying source of inflammation that could be a root cause of your eczema. It helps heal your skin from within for noticeably clearer skin and less itch.

Track your progress to monitor changes over time.

DUPIXENT works from the inside, targeting an underlying source of inflammation.

DUPIXENT may help to heal the skin from within by targeting a source of inflammation that could be a root cause of eczema. DUPIXENT may help reduce this inflammation and the signs and symptoms of eczema to help make skin noticeably clearer. DUPIXENT is not an immunosuppressant and does not require routine blood monitoring.

Watch the video to see what happens beneath the skin and how DUPIXENT works to help manage your symptoms.

Transcript

A Look Inside: Understanding the Science

Please stay tuned until the end of the video for the full Important Safety Information.

Today we’re going to be learning more about uncontrolled moderate-to-severe eczema (atopic dermatitis), and how DUPIXENT® (dupilumab) might be able to help.

Think about how eczema (atopic dermatitis) has impacted your skin. You have the next possible flare-up, your ongoing symptoms, and trying to manage them. The topical prescription lotions, creams, and steroid treatments you’ve been prescribed may not be working as well as you would like, and that can be frustrating. Well, eczema is more than a chronic skin condition that appears on the surface of the skin. It's a disease caused in part by an overactive immune system that leads to more inflammation than normal in your body.

In people with eczema, immune cells in the deeper layers of the skin send too many inflammatory signals to the surface, causing an itchy rash.

This inflammation can cause red, dry patches that lead to ongoing symptoms, like itching and scratching.

And continuous scratching breaks down the outer layer of the skin, which allows germs, irritants, and allergens to get in.

In response to these invaders, your immune system continues to send inflammatory signals to the surface, causing even more redness and itching.

So, what if there was another way to help address a source of inflammation that can cause the itch-scratch cycle?

Let’s take a look at DUPIXENT.

Unlike topical steroids, DUPIXENT works by targeting an underlying source of inflammation deep beneath the skin to help prevent flare-ups on the surface.

DUPIXENT works beneath the skin by attaching to certain proteins on the immune cells, inhibiting—or blocking—some of the inflammatory signals that contribute to eczema.

Think of it like this: There are calls you want to receive, like calls from friends and family. But then, there are those pesky spam calls.

If you add a spam filter to your phone that helps lower the amount of pesky calls, you can answer the calls you do want to receive.

By blocking some of these overactive signals—much like reducing the number of pesky calls you receive—DUPIXENT helps to reduce the inflammation that leads to symptoms you see and feel on the surface of your skin.

That means clearer skin and noticeably less itch. Of course, as you consider DUPIXENT, it’s good to keep in mind that if you have a parasitic (helminth) infection, you should talk to your doctor about having that treated before starting DUPIXENT. In a 52-week clinical trial with adults taking DUPIXENT plus a topical corticosteroid (TCS) (compared to those taking a TCS only), nearly 3 times saw clear or almost clear skin (39% versus 12% on TCS only at 16 weeks).

And, 22% of adults taking DUPIXENT plus TCS saw clear or almost clear skin at both 16 and 52 weeks versus 7% on TCS only.

Nearly 4 times had significant itch reduction at 1 year (51% at 52 weeks versus 13% on TCS only). 59% had significantly less itch versus 20% on TCS only at 16 weeks, and 18% had itch reduction in as fast as 2 weeks vs 8% on TCS only.

DUPIXENT was studied in 3 clinical trials with more than 2,100 adults with uncontrolled moderate-to-severe eczema.

The most common side effects in patients with eczema include injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia). Remember, eczema is a chronic condition. It’s important to take your medication exactly as your doctor prescribes.

So, get ready to get ahead of your symptoms with DUPIXENT, and roll up those sleeves—DUPIXENT helps heal your skin from within.

INDICATION DUPIXENT

DUPIXENT is a prescription medicine used to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 months of age.

IMPORTANT SAFETY INFORMATION

Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT.

Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:

have eye problems.
have a parasitic (helminth) infection.
are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT.
are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
- A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.
are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you are taking oral, topical or inhaled corticosteroid medicines or if you have atopic dermatitis and asthma and use an asthma medicine. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.
DUPIXENT can cause serious side effects, including:

Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue, or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area.
Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an eye exam if needed.
Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.

Please see accompanying full Prescribing Information including Patient Information.

US.DUP.23.09.0090 February 2024

DUPIXENT Clinical Trial Results

Results in Adults

Long term results from a 52-week clinical trial in 421 patients with uncontrolled moderate-to-severe eczema:

CLEAR OR ALMOST CLEAR SKIN

AT 16 WEEKS

39% taking DUPIXENT + TCS vs 12% using TCS only

LONG-LASTING CLEARER SKIN

AT 16 AND 52 WEEKS

22% taking DUPIXENT + TCS vs 7% using TCS only

FAST ITCH RELIEF

AS SOON AS 2 WEEKS

18% taking DUPIXENT + TCS vs 8% using TCS only

SIGNIFICANT ITCH REDUCTION

AT 16 WEEKS

59% taking DUPIXENT +TCS vs 20% using TCS only

ITCH RELIEF THAT LASTS

AT 52 WEEKS

51% taking DUPIXENT + TCS vs 13% using TCS only

SAFETY RESULTS:
The most common side effects observed in clinical trials were injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, cold sores in the mouth or on the lips, and high count of a certain white blood cell (eosinophilia).

Long-term safety results for adults continuing on DUPIXENT in the extension study for nearly 5 years were consistent with the adult clinical trials.

Use the slider to view these before and after results with 16 weeks of treatment with DUPIXENT. Real patient shown. Additional factors (including possible use of other treatments) may have impacted results. Individual results may vary.

Click and drag
to see results

Results in Teens (Ages 12-17 Years)

Results from a 16-week trial in 251 patients ages 12-17 years with uncontrolled moderate-to-severe eczema:

12X SAW CLEAR OR ALMOST
CLEAR SKIN

24% vs 2% not taking DUPIXENT (placebo)

~7X EXPERIENCED ITCH RELIEF

37% vs 5% not taking DUPIXENT (placebo)

NEARLY HALF OF TEENS SAW

≥75% CLEARER SKIN

42% vs 8% in those not taking DUPIXENT (placebo)

SOME EVEN SAW

≥90% CLEARER SKIN

23% vs 2% not taking DUPIXENT (placebo)

YOU CAN TAKE DUPIXENT WITH OR WITHOUT A TOPICAL CORTICOSTEROID (TCS)

*A treatment that appears to be real but contains no medicine.

SAFETY RESULTS:
Long-term safety results for teens continuing on DUPIXENT in the pediatric extension study through 1 year were consistent with the adult clinical trials.

Use the slider to view these before and after results of an actual 12-year-old patient after 16 weeks of treatment with DUPIXENT in a clinical trial. This patient did not meet clinical trial criteria for clear or almost clear skin at 16 weeks. Individual results may vary.

Click and drag
to see results

Results in Children (Ages 6-11 Years)

Results from a 16-week clinical trial with 367 patients ages 6-11 years with uncontrolled moderate-to-severe eczema:

>2X SAW CLEAR OR ALMOST CLEAR SKIN

30% on 300 mg every 4 weeks + TCS vs 13% on TCS only
39% on 200 mg every 2 weeks + TCS vs 10% on TCS only

~4.5X HAD LESS ITCH

54% on 300 mg every 4 weeks + TCS vs 12% on TCS only
61% on 200 mg every 2 weeks + TCS vs 13% on TCS only

MORE THAN HALF OF CHILDREN SAW

≥75% CLEARER SKIN

75% on 300 mg every 4 weeks + TCS vs 28% on TCS only
75% on 200 mg every 2 weeks + TCS vs 26% on TCS only

YOUR HEALTHCARE PROVIDER WILL TELL YOU HOW MUCH DUPIXENT TO INJECT AND HOW OFTEN.

YOU CAN TAKE DUPIXENT WITH OR WITHOUT A TOPICAL CORTICOSTEROID (TCS)

SAFETY RESULTS:
Long-term safety results for children continuing on DUPIXENT with or without TCS in the pediatric extension study through 1 year were consistent with the adult clinical trials.

Children who weighed 66 lb or more received DUPIXENT 200 mg every 2 weeks after an initial loading dose of 400 mg (two, 200-mg injections), and children who weighed less than 66 lb received DUPIXENT 300 mg every 4 weeks after an initial loading dose of 600 mg (two, 300-mg injections). Your healthcare provider will tell you how much DUPIXENT to inject and how often.

Use the slider to view before and after results of an actual 10-year-old patient after 16 weeks of treatment with DUPIXENT and a topical steroid in a phase 3 clinical trial. A clinical responder was defined as a patient achieving IGA 0 or 1 (clear or almost clear skin). Individual results may vary.

Click and drag
to see results

Results in Young Children (Ages 6 Months-5 Years)

Results from a 16-week clinical trial in 162 patients ages 6 months to 5 years with uncontrolled moderate-to-severe eczema:

7X SAW CLEAR OR ALMOST
CLEAR SKIN

28% on DUPIXENT + TCS vs 4% on TCS only

~5X HAD LESS ITCH

48% on DUPIXENT + TCS vs 9% on TCS only

HALF OF YOUNG CHILDREN SAW

≥75% CLEARER SKIN

53% on DUPIXENT + TCS vs 11% on TCS only

YOU CAN TAKE DUPIXENT WITH OR WITHOUT A TOPICAL CORTICOSTEROID (TCS)

SAFETY RESULTS:
Long-term safety results in young children continuing on DUPIXENT with or without TCS in the pediatric extension study through 1 year were consistent with the adult clinical trials. In addition, hand-foot-and-mouth disease and warts were reported. In these reported cases, patients continued treatment with DUPIXENT.

Common Concerns

“No Treatment Will Work for Me.”

Not everyone will respond the same way to treatment. But one way to know how you’re responding to treatment is to track your progress. You can write down your symptoms when you notice them. You could also take pictures of eczema patches regularly. Remember, eczema can look different in individuals depending on skin tone, and the severity of symptoms may vary.

Consider using a journal, such as your DUPIXENT MyWay Patient Journal, to keep track of all your symptoms so you can share more information with your healthcare provider. Together, you can ensure that you get the most from your treatment. If you haven’t received a journal, or have misplaced it, call 1-844-DUPIXENT (1-844-387-4936), option 1 to request one.

“My Treatment Isn’t Working as Fast as I Hoped.”

It’s important to stick with your treatment as prescribed, as results may vary and changes in symptoms may happen gradually.

"I Don’t Understand How It Works."

DUPIXENT works by targeting a key source of inflammation under the skin that contributes to an overactive immune system. An overactive immune system leads to more inflammation than normal in the body, contributing to the symptoms you see and feel on the surface of your skin.

Frequently Asked Questions

About DUPIXENT

How does DUPIXENT work?

DUPIXENT works with your body’s immune system to help reduce inflammation contributing to your eczema, which may help reduce your moderate-to-severe eczema symptoms and may give you noticeably clearer skin.

DUPIXENT works by targeting an underlying source of inflammation that can be a root cause of your moderate-to-severe eczema.

How will DUPIXENT interact with other medications?

DUPIXENT has not been studied with every medication that’s available. Tell your healthcare provider about all of the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, before starting DUPIXENT.

DUPIXENT can be used with or without topical corticosteroids.

Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you’re taking oral, topical, or inhaled corticosteroid medicines and if you have atopic dermatitis and asthma and use an asthma medicine. Do not change or stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.

You should not receive a “live vaccine” right before and during treatment with DUPIXENT.

Speak with your healthcare provider before making any change to your treatment regimen.

Are there any foods I should avoid while taking DUPIXENT?

There are no known foods you should avoid while taking DUPIXENT.

If you suspect a side effect with a particular food, notify your healthcare provider.

Can I consume alcoholic beverages while taking DUPIXENT?

Be sure to speak with your healthcare provider.

How does DUPIXENT affect the immune system?

DUPIXENT works by blocking two proteins that contribute to a type of inflammation that plays a major role in atopic dermatitis.

DUPIXENT affects the body’s immune system to reduce the inflammation associated with moderate-to-severe eczema, which may reduce symptoms such as rash, redness, and itch. It is not known if DUPIXENT can affect the immune response to parasitic (helminth) infections.

How to Take DUPIXENT

What is the dosing schedule for DUPIXENT? Do I need to take DUPIXENT at the same time every other week?

Use DUPIXENT exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much DUPIXENT to inject and how often you inject it. The recommended dose is specified below. DUPIXENT can be used with or without topical corticosteroids.

Adults ages 18+ and at any weight will have an initial loading dose of 600 mg (two, 300-mg injections) followed by one, 300-mg injection every 2 weeks
Children and teens ages 6-17 years and weighing 33 lb to under 66 lb will have an initial loading dose of 600 mg (two, 300-mg injections) followed by one, 300-mg injection every 4 weeks
Children and teens ages 6-17 years and weighing 66 lb to under 132 lb will have an initial loading dose of 400 mg (two, 200-mg injections) followed by one, 200-mg injection every 2 weeks
Children and teens ages 6-17 years and weighing 132 lb or more will have an initial loading dose of 600 mg (two, 300-mg injections) followed by one, 300-mg injection every 2 weeks
Children ages 6 months-5 years weighing 11 lb to under 33 lb will be given one, 200-mg injection every 4 weeks, with no initial loading dose recommended
Children ages 6 months-5 years weighing 33 lb to under 66 lb will be given one, 300-mg injection every 4 weeks, with no initial loading dose recommended

Setting a routine may help you remember to take DUPIXENT as prescribed.

Can I use it more frequently to get better results?

No, take DUPIXENT exactly as prescribed by your healthcare provider.

How long will I need to take DUPIXENT? What happens if I stop taking DUPIXENT?

Moderate-to-severe eczema is a chronic disease with no known cure.

Each person may respond differently to DUPIXENT. It’s possible that your symptoms could return if you stop taking DUPIXENT.

Speak with your healthcare provider before you decide to stop treatment or if you have questions regarding how long you’ll need to take DUPIXENT.

If I experience a delay with my dose, do I need to restart with the initial dose?

If your dose schedule is every other week and you miss a dose of DUPIXENT: Give the DUPIXENT injection within 7 days from the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, wait until the next scheduled dose to give your DUPIXENT injection.
If your dose schedule is every 4 weeks and you miss a dose of DUPIXENT: Give the DUPIXENT injection within 7 days from the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, start a new every 4 week dose schedule from the time you remember to take your DUPIXENT injection.

Side Effects of DUPIXENT

What are the serious side effects of DUPIXENT?

DUPIXENT can cause serious side effects, including:

Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue, or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area.
Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an eye exam if needed.
Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.

Talk with your healthcare provider about the benefits and the risks of taking DUPIXENT.

What are the common side effects of DUPIXENT?

The most common side effects in patients with eczema include injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia).

Talk with your healthcare provider about the benefits and risks of taking DUPIXENT.

Are there ways to manage some common side effects, such as injection site reactions?

It’s important to tell your healthcare provider about any side effects that you may be experiencing.

Before starting treatment, you or your caregiver should receive training from your healthcare provider on the right way to prepare and inject DUPIXENT under the skin. Carefully follow the Instructions for Use, which include choosing the initial injection site, as well as a different injection site each time you inject DUPIXENT. Instructions for Use can be found here and are included in your shipment of DUPIXENT.

Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.

Does DUPIXENT cause cold sores? If so, why?

Some patients taking DUPIXENT have reported cold sores, which can be caused by infection with a virus known as herpes simplex.

Storage and Travel

How is DUPIXENT stored? If I remove the medication from the refrigerator for 20-30 minutes and do not use it, can it be put back (stored) in the refrigerator?

DUPIXENT syringes should be stored in the refrigerator between 36 °F and 46 °F (2 °C and 8 °C). They should be kept in their original carton to protect them from light.

After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded. If you remove DUPIXENT from the refrigerator for 20-30 minutes, and do not use, you can and should put it back in the refrigerator.

DUPIXENT may be kept at room temperature up to 77 °F (25 °C) for a maximum of 14 days.

Can I travel with DUPIXENT?

You can travel with DUPIXENT; check with your airline if you have any specific questions or concerns.

HELP HEAL YOUR SKIN FROM WITHIN

How Does DUPIXENT Work?

DUPIXENT Clinical Trial Results

Results in Adults

Results in Teens (Ages 12-17 Years)

Results in Children (Ages 6-11 Years)

Results in Young Children (Ages 6 Months-5 Years)

Common Concerns

Frequently Asked Questions

About DUPIXENT

How to Take DUPIXENT

Side Effects of DUPIXENT

Storage and Travel

Other Questions