6+

months

of age

Expanded Indication

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

Not actual patients.

With DUPIXENT
change is achievable
in itch and skin lesions

6+
months
of age

In patients 6 months and older with moderate-to-severe atopic dermatitis, when topical Rx therapies are not enough
DUPIXENT: your first choice to adequately
control this chronic, systemic disease

Now Approved in Patients 6 Months to 5 Years of Age

TRIAL DESIGN

STUDIED IN PATIENTS AGED 6 MONTHS TO 5 YEARS IN A PIVOTAL CLINICAL TRIAL

In atopic dermatitis, DUPIXENT was studied in patients aged 6 months to 5 years in a 16-week trial1,2

INFANTS TO PRESCHOOLERS

6 months to 5 years of age
DUPIXENT + TCS

Patients
Patients 162
Pivotal Trial
Pivotal Trial 1 double-blind trial of DUPIXENT vs placebo; all patients received concomitant TCS (AD-1539: 16 weeks)
Dosage
Dosage No initial loading dose:
5 kg to <15 kg: 200 mg Q4W
15 kg to <30 kg: 300 mg Q4W
Baseline Disease Severitya
Baseline Disease Severitya Moderate disease (IGA 3): 23%
Severe disease: (IGA 4): 77%
Mean EASI: 34
Mean Worst Scratch/Itch NRSb: 7.6

Disease severity: Defined by an IGA score of ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 (clear) to 4 (severe); an EASI score ≥16 on a scale of 0 to 72; and a minimum body surface area involvement of ≥10%1,2

EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q4W, once every 4 weeks; SC, subcutaneous; TCS, topical corticosteroids.

a Mean disease duration was 3.4 years for infants/preschoolers. Mean age was 3.8 years for infants/preschoolers.1,2

b Weekly average of Worst Scratch/Itch NRS score (10 indicates the most severe).

In patients aged as young as 6 months to adults, DUPIXENT has been studied in >2800 patients with
uncontrolled moderate-to-severe atopic dermatitis across 6 pivotal trials1

Now Approved in Patients 6 Months to 5 Years of Age

EFFICACY

Significant itch reduction in infants to preschoolers
6 months
to 5 years

Significant itch reduction (≥4-point improvement in Worst Scratch/Itch NRS)
with DUPIXENT + TCS at Week 16 in AD-1539 (secondary endpoint)1,2,a,b

cDefinitive conclusions cannot be made as data were not multiplicity-controlled and P value was nominal.

Significant skin clearance in infants to preschoolers
6 months
to 5 years

At least 75% improvement in lesion extent and severity (EASI-75) with DUPIXENT + TCS
at Week 16 in AD-1539 (secondary endpoint)1,2,a,b

cDefinitive conclusions cannot be made as data were not multiplicity-controlled and P value was nominal.

28% of infants to preschoolers treated with DUPIXENT + TCS (n=83) achieved clear or almost-clear
skin (IGA 0 or 1)
at Week 16 vs 4% with placebo + TCS (n=79; P<0.0001; primary endpoint)1,2

a Full Analysis Set includes all subjects randomized.

b In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.

Now Approved in Patients 6 Months to 5 Years of Age

SAFETY PROFILE


Demonstrated Safety Profile in Patients as Young as 6 Months of Age

The safety profile in infants to preschoolers through Week 16 was similar to that of adults with atopic dermatitis1

Adverse reactions occurring in ≥1% of adult patients through Week 161
Injection site reaction
DUPIXENTc
(n=529) %
10%
Placebo
(n=517) %
5%
Conjunctivitisd
DUPIXENTc
(n=529) %
10%
Placebo
(n=517) %
2%
Blepharitis
DUPIXENTc
(n=529) %
<1%
Placebo
(n=517) %
<1%
Oral herpes
DUPIXENTc
(n=529) %
4%
Placebo
(n=517) %
2%
Keratitise
DUPIXENTc
(n=529) %
<1%
Placebo
(n=517) %
0%
Eye pruritus
DUPIXENTc
(n=529) %
1%
Placebo
(n=517) %
<1%
Oral herpes simplex virus infectionf
DUPIXENTc
(n=529) %
2%
Placebo
(n=517) %
1%
Dry eye
DUPIXENTc
(n=529) %
<1%
Placebo
(n=517) %
0%
Injection site reaction
DUPIXENT + TCSc
(n=110) %
10%
Placebo + TCS
(n=315) %
6%
Conjunctivitisd
DUPIXENT + TCSc
(n=110) %
9%
Placebo + TCS
(n=315) %
5%
Blepharitis
DUPIXENT + TCSc
(n=110) %
5%
Placebo + TCS
(n=315) %
1%
Oral herpes
DUPIXENT + TCSc
(n=110) %
3%
Placebo + TCS
(n=315) %
2%
Keratitise
DUPIXENT + TCSc
(n=110) %
4%
Placebo + TCS
(n=315) %
0%
Eye pruritus
DUPIXENT + TCSc
(n=110) %
2%
Placebo + TCS
(n=315) %
1%
Oral herpes simplex virus infectionf
DUPIXENT + TCSc
(n=110) %
1%
Placebo + TCS
(n=315) %
<1%
Dry eye
DUPIXENT + TCSc
(n=110) %
2%
Placebo + TCS
(n=315) %
<1%

aPooled analysis of SOLO 1, SOLO 2, and AD-1021 (phase 2 dose-ranging study).

bAnalysis of CHRONOS in which subjects were on background TCS therapy.

cDUPIXENT 600 mg at Week 0, followed by 300 mg every 2 weeks.

dConjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.

eKeratitis cluster includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.

fOther herpes simplex virus infection cluster includes herpes simplex, genital herpes, herpes simplex otitis externa, and herpes virus infection, but excludes eczema herpeticum.

The 52-week safety profile of DUPIXENT + TCS in adults was generally consistent with the Week 16 adult safety profile1

In an open-label extension study (AD-1434), the safety profile of DUPIXENT ± TCS in infants to preschoolers
observed through Week 52 was consistent with that seen in adults with atopic dermatitis1
  • In AD-1434, 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

Numerically fewer patients developed skin infections
compared with placebo2,g

Week 16, AD-1539
12% DUPIXENT + TCS
VS
24% PLACEBO + TCS

Discontinuation rates due to adverse events in infants to
preschoolers treated with DUPIXENT + TCS were
comparable to those with placebo + TCS2

Week 16, AD-1539
1% DUPIXENT + TCS
VS
1% PLACEBO + TCS
  • Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment1

  • g Data reflect adjudicated nonherpetic skin infections through Week 16.

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.

NOT METABOLIZED THROUGH THE LIVER
OR EXCRETED THROUGH THE KIDNEYS1

  • No known drug-to-drug interactions

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

Other attributes1


DUPIXENT IS NOT AN
IMMUNOSUPPRESSANT AND AVOIDS
BROAD IMMUNOSUPPRESSION

  • It is unknown if DUPIXENT will influence the
    immune response against helminth infections

NO REQUIREMENT FOR INITIAL LAB
TESTING OR ONGOING LAB MONITORING,
according to the Prescribing Information

Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT1

  • Avoid use of live vaccines in patients treated with DUPIXENT

Now Approved in Patients 6 Months to 5 Years of Age

DOSAGE AND ADMINISTRATION


In infants to preschoolers, one dose every 4 weeks1
Weight-tiered dosage regimen in infants to preschoolersa
5 to <15 kg
No initial loading
dose
recommended
Initial and
subsequent dosage:

200 mg Q4W

1 pre-filled syringe

15 to <30 kg
No initial loading
dose
recommended
Initial and
subsequent dosage:

300 mg Q4W

1 pre-filled syringe

a 5 kg is equal to 11 lb; 15 kg is equal to 33 lb; 30 kg is equal to 66 lb.

  • Rotate injection site with each injection1
  • The DUPIXENT pre-filled syringe should be given by a caregiver in children younger than 12 years of age1
  • Provide proper training to caregivers on the preparation and administration of DUPIXENT prior to use, according to the Instructions for Use1

Enroll your
patients in


Learn how to get your patients started with DUPIXENT MyWay. Fill out the enrollment form with your patients.

Learn more

DUPIXENT MyWay
ENROLLMENT FORMS

FOR DERMATOLOGISTS
English Enrollment Form
Spanish Enrollment Form
FOR ALLERGISTS
English Enrollment Form
Spanish Enrollment Form

References:

  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals.
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 who received DUPIXENT compared to those who received placebo. 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.

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 atopic dermatitis or CRSwNP who have 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% at Week 16) in adult 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.
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).