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

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%

Treatment-emergent eosinophilia (≥5,000 cells/mcL) was reported in2:

  • <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)g
  • 8% of DUPIXENT-treated subjects and 0% of placebo-treated subjects (AD-1539)

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.

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 polyposis clinical trial program; PRIME and PRIME2 are part of the prurigo nodularis clinical trial program.

Numerically fewer adolescent patients treated with DUPIXENT developed skin infections compared with placebo in AD-1526 (11% vs 20%)2

Long-term safety observed in adolescents

The long-term safety of DUPIXENT in adolescents was assessed in an open‑label extension trial (AD-1434) through Week 521
  • The safety profile of DUPIXENT through Week 16 (in pivotal trials) and Week 52 (in an open-label extension trial) observed in adolescents was consistent with that seen in adults with atopic dermatitis
Discontinuation rates in adolescents due to adverse events with DUPIXENT were comparable to those with placebo2,3
  • 0% of adolescent patients treated with DUPIXENT discontinued treatment through Week 16 vs 1.2% of adolescent patients treated with placebo discontinued through Week 16 (AD-1526)

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 in patients treated with DUPIXENT
Important considerations

NO BOXED WARNING2

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 KIDNEYS2

  • 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