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Infants to Preschoolers Safety Profile

In the treatment of infants to preschoolers (6 months to 5 years of age) with uncontrolled moderate-to-severe atopic dermatitis

Safety profile demonstrated up to Week 161

The safety profile of DUPIXENT + TCS in infants to preschoolers through
Week 16 was similar to that in 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%
Other 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%
Other 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%

Treatment-emergent eosinophilia (≥5,000 cells/mcL) was reported in1:

  • <3% of DUPIXENT-treated subjects and <0.5% of placebo-treated subjects (SOLO 1, SOLO 2, and AD-1021; DRI12544, QUEST, and VOYAGE; SINUS-24 and SINUS-52; PRIME and PRIME2; BOREAS and NOTUS; CUPID-A, CUPID-B, and CUPID-C)g
  • 8% of DUPIXENT-treated subjects and 0% of placebo-treated subjects (AD-1539)

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

b Analysis of CHRONOS in which subjects were on background TCS therapy.1

cDUPIXENT 600 mg at Week 0, followed by 300 mg every 2 weeks.1

d Conjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.1

e Keratitis cluster includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.1

f Other herpes simplex virus infection cluster includes herpes simplex, genital herpes, herpes simplex otitis externa, and herpes virus infection, but excludes eczema herpeticum.1

gDRI12544, QUEST, and VOYAGE are part of the asthma clinical trial program; SINUS-24 and SINUS-52 are part of the chronic rhinosinusitis with nasal polyps clinical trial program; PRIME and PRIME2 are part of the prurigo nodularis clinical trial program; BOREAS and NOTUS are part of the chronic obstructive pulmonary disease clinical program; CUPID-A, CUPID-B, and CUPID-C are part of the chronic spontaneous urticaria clinical program.

Numerically fewer infants to preschoolers treated with DUPIXENT + TCS developed skin infections compared with placebo + TCS in AD-15392,h

  • 12% of infants to preschoolers treated with DUPIXENT + TCS vs 24% with placebo + TCS2

hData reflect adjudicated nonherpetic skin infections through Week 16.

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

  • 1% of infants to preschoolers treated with DUPIXENT + TCS (n=83) and placebo + TCS (n=78) discontinued treatment through Week 162

iAnalysis done in overall study population.

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 treatment.1

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

  • Avoid use of live vaccines during treatment with DUPIXENT1

Long-term safety profile observed in infants to preschoolers

The long-term safety of DUPIXENT ± TCS in infants to preschoolers was assessed in an open-label extension study (AD-1434)1

  • The safety profile through Week 52 was similar to the safety profile observed through Week 16 in AD-1539
  • The long-term safety profile of DUPIXENT ± TCS in infants to preschoolers was consistent with that seen in adults, adolescents, and children
  • 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
 

DUPIXENT demonstrated a generally consistent safety profile through Week 16 across multiple age populations as
young as 6 months1

Safety profile studied in >9000 patients across US-approved indications1,j

jPatient total included patients in AD trials (SOLO 1, SOLO 2, CHRONOS, AD-1021, AD-1526, AD-1652, AD-1539, and AD-HAFT), asthma trials (DRI12544, QUEST, VENTURE, and VOYAGE), CRSwNP trials (SINUS-24 and SINUS-52), EoE trials (EoE-1 and EoE-2), PN trials (PRIME and PRIME2), COPD trials (BOREAS and NOTUS), CSU trials (CUPID-A, CUPID-B, and CUPID-C), and the BP trial (ADEPT).

AD, atopic dermatitis; BP, bullous pemphigoid; COPD, chronic obstructive pulmonary disease; CRSwNP, chronic rhinosinusitis with nasal polyps; CSU, chronic spontaneous urticaria; EoE, eosinophilic esophagitis; PN, prurigo nodularis.

Other CONSIDERATIONS

NOT AN IMMUNOSUPPRESSANT
OR A STEROID1

NO INITIAL LAB TESTING OR
ONGOING
LAB MONITORING
according to the
Prescribing Information1

NO KNOWN DRUG-TO-DRUG
INTERACTIONS1

  • Not metabolized through the liver or excreted
    through the kidneys

NO BOXED WARNING1

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

SELECT IMPORTANT
SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, acute generalized exanthematous pustulosis (AGEP), serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum,and erythema multiforme have been reported. A case of AGEP was reported in an adult subject who participated in the bullous pemphigoid development program. 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 below.

TCS, topical corticosteroids.

READY TO PRESCRIBE DUPIXENT?

DOSAGE AND ADMINISTRATION