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Demonstrated safety profile in patients as young as 6 months of age

The safety profile of DUPIXENT in pediatric patients through Week 16 was similar to that in adults1

Adverse reactions occurring in ≥1% of adult patients through Week 161
DUPIXENT 300 mg Q2W MONOTHERAPYa
DUPIXENTc
(n=529)
%
PLACEBO
(n=517)
%
Injection site reaction
10
5
Conjunctivitisd
10
2
Blepharitis
<1
<1
Oral herpes
4
2
Keratitise
<1
0
Eye pruritus
1
<1
Other herpes simplex virus infectionf
2
1
Dry eye
<1
0
DUPIXENT 300 mg Q2W + TCSb
DUPIXENT + TCSc
(n=110)
%
PLACEBO + TCS
(n=315)
%
Injection site reaction
10
6
Conjunctivitisd
9
5
Blepharitis
5
1
Oral herpes
3
2
Keratitise
4
0
Eye pruritus
2
1
Other herpes simplex virus infectionf
1
<1
Dry eye
2
<1

Treatment-emergent eosinophilia (≥5000 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)

Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT.1

  • Avoid use of live vaccines during treatment with DUPIXENT

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

bAnalysis 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

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

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

fOther 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.1

The safety profile in pediatric patients through Week 16a and Week 52b was consistent with that of adults with AD1

  • In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) were reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation

aIn pivotal trials.

bIn an open-label extension trial, AD-1434.

Other attributes and considerations

NOT AN
IMMUNOSUPPRESSANT
OR A STEROID1

NO KNOWN DRUG-TO-DRUG INTERACTIONS1

Not metabolized through the liver or
excreted through the kidneys

NO INITIAL LAB TESTING OR ONGOING LAB MONITORING

according to the Prescribing Information1

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.

Watch healthcare providers discuss treatment with DUPIXENT

PEER VIDEOS

AD, atopic dermatitis; IGA, Investigator's Global Assessment; Q2W, once every 2 weeks; TCS, topical corticosteroids.