CHLOE, 26
LIVING WITH MODERATE-TO-SEVERE AD
SINCE EARLY CHILDHOOD
Real patient being treated with DUPIXENT
Individual results may vary

SIENNA, 4
STORY INSPIRED BY REAL PATIENT
Not an actual patient
Individual results may vary

Change Their
Story Together
By partnering with a specialist

DUPIXENT is the first and only biologic to treat
uncontrolled moderate-to-severe atopic dermatitis
in adult and pediatric patients 6+ months of age1

6

Months

To 5 Years
Of Age

Expanded
Indication

NOW APPROVED IN CHILDREN AGED 6 MONTHS TO 5 YEARS WITH UNCONTROLLED MODERATE-TO-SEVERE ATOPIC DERMATITIS

SEE THE DATA DUP.22.08.0193

HELP CHANGE
THEIR STORY

Discover how DUPIXENT may help and hear real provider and patient experiences

IDENTIFY APPROPRIATE PATIENTS

Appropriate patients may benefit by seeing a dermatologist or allergist

When topical Rx therapies are not enough, patients aged 6 months and older with moderate-to-severe disease may be appropriate for DUPIXENT. Consider a referral if they1:

  • Have tried a variety of topical prescription therapies for moderate-to-severe atopic dermatitis and are still uncontrolled1
  • Suffer from inadequate control of pruritus1
  • Have ≥10% of their body covered with lesions and/or may involve problem areas, such as the face, hands, and feet1
  • Have moderate-to-severe erythema and moderate-to-severe papulation/infiltration (defined in clinical trials as an IGA score of 3 or 4)1,2
    IGA, Investigator's Global Assessment.
Identify appropriate patients to refer

PARTNER WITH A SPECIALIST

Find a DERMATOLOGIST or ALLERGIST for your appropriate patients trapped in flare, treat, repeat cycles

Use the Healthgrades® tool to find and partner with a nearby eczema specialist.

ABOUT DUPIXENT

DUPIXENT is the first biologic that specifically targets a
source of underlying inflammation to proactively treat
atopic dermatitis1,3

Atopic dermatitis is a chronic, systemic disease driven in part by persistent underlying type 2 inflammation4

  • Even when patients are not in a flare, they continue to have underlying inflammation3
  • Systemic treatment may be needed to help manage
    this disease1,5

   
WATCH HOW
DUPIXENT WORKS

Change their story by partnering with a specialist. DUPIXENT has demonstrated itch relief and skin clearance1


DUPIXENT has proven itch relief and skin clearance
in patients 6+ months of age with uncontrolled moderate-to-severe atopic dermatitis1

Itch reduction1

Skin clearance1,6

DUPIXENT has a demonstrated long-term safety profile
across patients 6+ months of age1

Demonstrated safety profile
through 52 weeks1

Most common adverse reactions

The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.1

Trial Designs and Results

Important Considerations

NO BOXED WARNING1

SELECT IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information.



Other Attributes
of DUPIXENT

DUPIXENT is not an
immunosuppressant
or a steroid1

No requirement for initial lab testing
or ongoing lab monitoring according
to the Prescribing Information1

Real-World Experience

5 years on the market

since initial FDA
approval in atopic
dermatitisa

aFDA approved since 2017 for adults, 2019 for adolescents (aged 12-17 years), 2020 for children (aged 6-11 years), and
2022 for infants to preschoolers (aged 6 months to 5 years) with uncontrolled moderate-to-severe atopic dermatitis.

6

Months

To 5 Years
Of Age

Expanded
Indication

NOW APPROVED IN CHILDREN AGED 6 MONTHS TO 5 YEARS WITH UNCONTROLLED MODERATE-TO-SEVERE ATOPIC DERMATITIS

SEE THE DATA DUP.22.08.0193
WATCH VIDEOS ABOUT DUPIXENT

    INDICATION
    DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

    IMPORTANT SAFETY INFORMATION
    CONTRAINDICATION:
    DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

    A patient who is appropriate for DUPIXENT is going to be a patient who has moderate-to-severe atopic dermatitis and who has failed prescription topical corticosteroids.

    It’s really important when talking with patients about DUPIXENT as a novel treatment option.

    I think patients really get it when we talk about the fact that it may address the underlying problem and that inflammatory cascade of atopic dermatitis.

    When I said, look, there’s something beyond creams, it was sort of like their eyes lit up. Like the idea that there was something else, you know, was really exciting for them.

    The way I describe DUPIXENT to my patients is that DUPIXENT inhibits IL-4 and IL-13 signaling.

    There are a number of things that really resonate with the patients, and one of them is the lack of laboratory monitoring.

    I make a point to say, it’s not a steroid. There’s no laboratory monitoring required, not at the beginning, not during therapy.

    This is not a steroid, it’s not an immunosuppressant. The patients don’t know that, and many of them are apprehensive because they think that this is.

    I think the referral patterns for me are skewed towards a more moderate-to-severe category.

    A lot of my patients have seen multiple providers, have tried a lot of different therapies, and so are more in that moderate-to-severe category.

    I solely see adult patients. They primarily are seeing their primary care provider if they tend to have more mild disease, and they’re referred to our clinic when they have more moderate-to-severe disease or disease that is poorly controlled.

    I think for me, safety profile is, you know, probably actually the most important thing, especially when treating children, and to have a medicine that has a long-term safety profile, like DUPIXENT, is really, really welcome for me as a pediatric dermatologist.

    In addition, not having any black box warnings is another thing that really resonates, and that there are various patient populations that have been enrolled in studies.

    I try to explain the drug, the mechanism, the safety profile all first before I say how the medicine is delivered.

    They were ready and happy to embrace this new treatment option for them.

    INDICATION AND IMPORTANT SAFETY INFORMATION
    INDICATION
    DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

    IMPORTANT SAFETY INFORMATION
    CONTRAINDICATION:
    DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

    WARNINGS AND PRECAUTIONS

    Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

    Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT versus placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

    Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

    Atopic Dermatitis Patients with Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

    Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

    Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

    Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

    ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.

    Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

    Please see accompanying full Prescribing Information.

    INDICATION

    DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

    INDICATION
    DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

    IMPORTANT SAFETY INFORMATION
    CONTRAINDICATION:
    DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

    [ALDREDGE]:
    Patients with atopic dermatitis…are referred to our clinic when they have more moderate-to-severe disease or disease that is poorly controlled.

    [DR LOCKSHIN]:
    The extent of disease based on body surface area, or the excoriations or erythema that they have is only part of the story. Assessing how much itch they have…

    [DR SIRI]:
    Chronicity of the disease, we spend an inordinate amount of time educating the patients that this is a long-term inflammatory disease, which is not going to go away after one treatment course.

    [ALDREDGE]:
    These patients have seen numerous providers, and many of them feel like they’ve been given every option. It may have worked for a little while, but they’re back again.

    [DR CRAIGLOW]:
    I have a patient who has tried, you know, multiple topical corticosteroids, topical calcineurin inhibitor and they’re not pretty clear, that’s when I’m starting to have the conversation with the patient and the family.

    [ALDREDGE]:
    The patient had been through numerous treatments, including moisturizers, topical corticosteroids, calcineurin inhibitors, and courses of systemic immunosuppressants numerous times throughout his life...but it did not last for long...so it really was the ideal opportunity to introduce DUPIXENT.

    INDICATION AND IMPORTANT SAFETY INFORMATION
    INDICATION
    DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

    IMPORTANT SAFETY INFORMATION
    CONTRAINDICATION:
    DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

    WARNINGS AND PRECAUTIONS

    Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

    Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT versus placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

    Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

    Atopic Dermatitis Patients with Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

    Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

    Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

    Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

    ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.

    Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

    Please see accompanying full Prescribing Information.

    INDICATION

    DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

    INDICATION
    DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

    IMPORTANT SAFETY INFORMATION
    CONTRAINDICATION:
    DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

    When I introduce DUPIXENT as a treatment option, we had a discussion of why we use DUPIXENT, and then possible side effects. When I think about my patients who’ve had moderate-to-severe, uncontrolled atopic dermatitis, I know that this patient needs a systemic treatment for their skin condition.

    So with any therapy, discussing safety and side effects is very important. The most common adverse reactions with an incidence greater than or equal to 1% at Week 16 in clinical trials were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infections, and dry eye.

    When you’re introducing DUPIXENT to a patient that you think would be a good candidate to start this therapy, they often want to talk about efficacy. When I think of a patient, I think about this young man, and he came back to see me about 4 weeks later. He became less itchy, more comfortable. And he wasn’t constantly thinking about his skin. His skin had healed in ways that he had never experienced.

    When we saw the patient back, his description of itching and the urge to scratch was much more encouraging. He felt like he had more control of his disease, more control of his itching as he was the one giving himself the shots. He felt like he was actually more involved in his treatment. And that gave him a sense of encouragement in terms of how he was going to break the itch-scratch cycle himself.

    In order to get my patient and her mother more comfortable with using a medication that’s an injection, I explained to them that injection therapy is not a new treatment to our armamentarium or to any of our patients.

    DUPIXENT has really revolutionized the way we treat atopic dermatitis.

    INDICATION AND IMPORTANT SAFETY INFORMATION
    INDICATION
    DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

    IMPORTANT SAFETY INFORMATION
    CONTRAINDICATION:
    DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

    WARNINGS AND PRECAUTIONS

    Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

    Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT versus placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

    Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

    Atopic Dermatitis Patients with Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

    Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

    Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

    Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

    ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.

    Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

    Please see accompanying full Prescribing Information.

    INDICATION

    DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

      INDICATION
      DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

      IMPORTANT SAFETY INFORMATION
      CONTRAINDICATION:
      DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

      My name is Dr Jennifer Soung, and I’m a dermatologist in Orange County, California.

      An eight-year-old boy who is Southeast Asian was referred to me by his pediatrician because of really stubborn disease. My patient had seen his pediatrician for several months before coming to see me.

      In skin of color, it can be harder to distinguish or make a diagnosis because it may not look so typical. The appearance of the lesions are different as well because the redness isn’t always so bright.

      Mom described it as his skin was on fire. Even, at times, she said it was like an active volcano. It was always brewing; he never had clear skin.

      He wanted to hide his eczema. Kids at school started to notice and would ask what was going on. Really, that sense of lack of control over his skin, his itching.

      What stood out for me in this situation that made me consider DUPIXENT is really how DUPIXENT works. In this situation, the parents knew that they needed something more.

      When I think about my patients who’ve had moderate-to-severe, uncontrolled atopic dermatitis, I think about DUPIXENT.

      When I prescribe DUPIXENT to my patient, I always share with them the most common adverse events.

      After starting DUPIXENT on his first visit back to the office, I didn’t even need to ask him how he was doing because he just smiled at me. I knew that we were on the right path to healing his skin because he had described a relief in his itch. That was a big accomplishment.

      I’ve seen him improve over several weeks, and his skin healed really well. He was wearing short sleeves and shorts when he came to the office. He no longer felt like he had to cover all his skin.

      I remember mom and dad telling me it was like a huge weight that had been lifted off of them because they saw that this medicine was actually helping relieve that itch and break that itch-scratch cycle.

      So the family, as well as the patient, have been thrilled. And even the little boy, my patient, says that the injection now is worth it.

      INDICATION AND IMPORTANT SAFETY INFORMATION
      INDICATION
      DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

      IMPORTANT SAFETY INFORMATION
      CONTRAINDICATION:
      DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

      WARNINGS AND PRECAUTIONS

      Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

      Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT versus placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

      Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

      Atopic Dermatitis Patients with Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

      Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

      Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

      Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

      ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.

      USE IN SPECIFIC POPULATIONS

      Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.

      Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

      Please see accompanying full Prescribing Information.

      INDICATION

      DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

      INDICATION
      DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

      IMPORTANT SAFETY INFORMATION
      CONTRAINDICATION:
      DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

      VO (ANNIE):
      “It was hard to not have a solution that worked for me. There was always something that I needed to do, always like a medicine I needed to take or a topical that I had to put on my skin.”

      VO (SUE):
      “As a mom, I felt helpless, and we really felt out of control, and we needed to find something different, something that would work for her.”

      VO (SUE):
      “Annie’s eczema specialist knew about DUPIXENT and thought that Annie was appropriate for it.”

      VO (ANNIE): “Since starting DUPIXENT, my skin is a lot more clear. It’s a lot calmer.

      VO (SUE):
      “We did notice a difference…and it has continually improved.”

      VO (ANNIE):
      “My life doesn’t resolve around my skin anymore.”

      VO (SUE):
      “Now, when she goes out and plays volleyball or hangs out with her friends, she can just be a kid, and that is a huge relief as a parent.”

      INDICATION AND IMPORTANT SAFETY INFORMATION
      INDICATION
      DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

      IMPORTANT SAFETY INFORMATION
      CONTRAINDICATION:
      DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

      WARNINGS AND PRECAUTIONS

      Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

      Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT versus placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

      Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

      Atopic Dermatitis Patients with Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

      Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

      Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

      Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

      ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.

      USE IN SPECIFIC POPULATIONS

      Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.

      Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

      Please see accompanying full Prescribing Information.

      INDICATION

      DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

      INDICATION
      DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

      IMPORTANT SAFETY INFORMATION
      CONTRAINDICATION:
      DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

      VO (BRITTON):

      Growing up, my skin was flaking, my skin was itching. My skin was red…

      …I would just scratch constantly,

      and the itching was something that I could never satisfy.

      Over time, my itching got less and less.

      After starting treatment, I started noticing some changes with my skin…

      I noticed that the irritation was reduced, and I noticed that the overall texture of my skin was smoother.

      Today, I feel like I can manage my atopic dermatitis symptoms…

      and that is a huge relief! Of course, this is just my experience, and everyone’s experience with DUPIXENT will be different.

      INDICATION AND IMPORTANT SAFETY INFORMATION
      INDICATION
      DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

      IMPORTANT SAFETY INFORMATION
      CONTRAINDICATION:
      DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

      WARNINGS AND PRECAUTIONS

      Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

      Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT versus placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

      Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

      Atopic Dermatitis Patients with Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

      Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

      Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

      Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

      ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.

      USE IN SPECIFIC POPULATIONS

      Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.

      Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

      Please see accompanying full Prescribing Information.

      INDICATION

      DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.


      FAQs

      Questions about DUPIXENT?

      Below are the answers to some of the most frequently asked questions about DUPIXENT.

      DUPIXENT is a biologic therapy that inhibits IL-4 and IL-13 signaling, two sources of type 2 inflammation. It is not an immunosuppressant or a steroid.1

      The mechanism of dupilumab action has not been definitively established.

      When topical Rx therapies aren't enough, DUPIXENT is the first and only biologic approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood (6+ months of age).1

      DISCOVER HOW DUPIXENT WORKS

      DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6+ months with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Patients may be appropriate for DUPIXENT if they1:

      • Have tried a variety of topical Rx therapies and are still uncontrolled1
      • Suffer from inadequate control of pruritus1
      • Have ≥10% of their body covered with lesions and/or may involve problem areas such as the face, hands, and feet1
      • Have moderate-to-severe erythema and moderate-to-severe papulation/infiltration (Investigator's Global Assessment [IGA] score of 3=moderate or 4=severe)1,2
      Learn how to identify appropriate patients

      DUPIXENT is typically prescribed by a specialist, such as a dermatologist or allergist. If you have a patient aged 6+ months with uncontrolled moderate-to-severe atopic dermatitis who you think might be appropriate for DUPIXENT, consider referring them to an eczema specialist.1

      For help finding a specialist, use the Healthgrades tool.


      Sanofi US and Regeneron do not endorse or recommend any particular physician, and search results do not include a comprehensive list of doctors in your area.

      A specialist can confirm which patients 6+ months of age with uncontrolled moderate-to-severe atopic dermatitis may need a different approach, and prescribe a biologic like DUPIXENT—the first and only biologic approved from infancy to adulthood.1

      Specialist referral can occur at any point in the clinical management of uncontrolled moderate-to-severe atopic dermatitis (6+ months).

      Uncontrolled moderate-to-severe AD is a chronic, systemic disease that for many patients will be a lifelong condition, one that may necessitate continuous treatment. We don't know which patients may outgrow their condition, and in the meantime, those with uncontrolled disease despite TCS use may need continuous therapy to adequately control their chronic itch and skin lesions.8,10

      Find a specialist near you

      The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.1

      See results with DUPIXENT

      The safety of DUPIXENT was assessed both as monotherapy and in combination with TCS in adult patients with moderate-to-severe atopic dermatitis; as monotherapy in adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis; in combination with TCS in children 6 to 11 years with severe atopic dermatitis; and in combination with TCS in infants to preschoolers 6 months to 5 years of age with moderate-to-severe atopic dermatitis. The safety profile through Week 16 in each pediatric age group was similar to that of adults with atopic dermatitis.

      In an open-label extension study, the safety profile through Week 52 in each pediatric age group was consistent with that of adults with atopic dermatitis. Hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.1

      See the safety profile

      DUPIXENT is an injectable medicine that is administered by subcutaneous injection. DUPIXENT is intended for use under the guidance of a healthcare provider. The DUPIXENT pre-filled pen is for use in adult and pediatric patients aged 2 years and older. The DUPIXENT pre-filled syringe is for use in adult and pediatric patients aged 6 months and older. A caregiver or patient 12 years of age and older may inject DUPIXENT using the pre-filled syringe or pre-filled pen. In pediatric patients 12 to 17 years of age, it is recommended that DUPIXENT be administered by or under the supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.1

      EXPLORE DOSAGE AND ADMINISTRATION

      99% of commercial patients (6+ years of age) nationally are covered for DUPIXENT, with 88% of commercial patient lives having to fail only 1 or 2 prescription topical treatments.2,a

      aMMIT Analysis, July 2022.
        Learn more about coverage

      For patients with a valid prescription for DUPIXENT, support is available through the DUPIXENT MyWay® patient support program. Patients who enroll can receive:

      • Insightful tips and tools to help them along the way
      • Supplemental injection training virtually or over the phone
      • Financial assistance for eligible patients
      • Assistance with insurance questions
      • Assistance locating a specialty pharmacy that can dispense DUPIXENT
      Learn more about DUPIXENT MyWay®
      EXPLORE PATIENT SUPPORT

      DUPIXENT MyWay® helps ensure patients have access
      to DUPIXENT and are provided with assistance
      in navigating the insurance process

      • 99% of commercial patients (6+ years of age) nationally are covered for DUPIXENT, with 88% of commercial patient lives having to fail only 1 or 2 prescription topical treatments.2,a

      aMMIT Analysis, July 2022.

      LEARN MORE ABOUT ACCESS

      Important Safety
      Information and Indications

      CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

      WARNINGS AND PRECAUTIONS

      Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

      Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT versus placebo, with conjunctivitis being the most frequently reported eye disorder. Conjunctivitis also occurred more frequently in chronic rhinosinusitis with nasal polyposis subjects and prurigo nodularis subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in AD patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

      Eosinophilic Conditions: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA), conditions which are often treated with systemic corticosteroid therapy. These events may be associated with the reduction of oral corticosteroid therapy. Healthcare providers should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adult subjects who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult subjects who participated in the asthma development program as well as in adult subjects with co-morbid asthma in the CRSwNP development program. A causal association between DUPIXENT and these conditions has not been established.

      Acute Asthma Symptoms or Deteriorating Disease: Do not use DUPIXENT to treat acute asthma symptoms, acute exacerbations, acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of DUPIXENT.

      Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

      Patients with Co-morbid Asthma: Advise patients with co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.

      Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

      Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves. Helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old in the pediatric asthma development program.

      Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

      ADVERSE REACTIONS:

      • Atopic Dermatitis: The most common adverse reactions (incidence ≥1%) in patients are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.
      • Asthma: The most common adverse reactions (incidence ≥1%) are injection site reactions, oropharyngeal pain, and eosinophilia.
      • Chronic Rhinosinusitis with Nasal Polyposis: The most common adverse reactions (incidence ≥1%) are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
      • Eosinophilic Esophagitis: The most common adverse reactions (incidence ≥2%) are injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
      • Prurigo Nodularis: The most common adverse reactions (incidence ≥2%) are nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.

      USE IN SPECIFIC POPULATIONS

      • Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
      • Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

      Please see accompanying full Prescribing Information.

      Indications

      Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

      Asthma: DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.

      Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP): DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled CRSwNP.

      Eosinophilic Esophagitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE).

      Prurigo Nodularis: DUPIXENT is indicated for the treatment of adult patients with prurigo nodularis (PN).

      References:

      1. DUPIXENT Prescribing Information.
      2. Data on file, Regeneron Pharmaceuticals, Inc.
      3. Gandhi NA, Bennett BL, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35-50.
      4. Leung DYM, Boguniewicz M, Howell MD, Nomura I, Hamid QA. New insights into atopic dermatitis. J Clin Invest. 2004;113(5):651-657.
      5. Boguniewicz M, Fonacier L, Guttman-Yassky E, Ong PY, Silverberg J, Farrar JR. Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Ann Allergy Asthma Immunol. 2018;120(1):10-22.e2.
      6. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
      7. Paller AS, Siegfried EC, Thaçi D, et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: a randomized, double-blinded, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2020;83(5):1282-1293.
      8. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303.
      9. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44-56.
      10. Raimondo A, Lembo S. Atopic dermatitis: epidemiology and clinical phenotypes. Dermatol Pract Concept. 2021;11(4):e2021146.