Child Safety Profile

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

The long-term safety of DUPIXENT
+ TCS in children (and adolescents)
was assessed in an open-label extension study (Trial 7)1

Safety in children demonstrated up to Week 162

The most common adverse reactions (incidence ≥1% at Week 16) in adult patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.1

The safety profile of DUPIXENT + TCS in patients aged 6 to 11 years through Week 16 was similar to the safety profile from studies in adults and adolescents with atopic dermatitis.1

Safety in children demonstrated up to Week 162

Adverse reactions occurring in ≥2% of children through Week 16 and higher rate with DUPIXENT2
Upper respiratory tract infection
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
15%
PLACEBO
(n=60) n (%)
8.3%
Injection site reaction
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
10%
PLACEBO
(n=60) n (%)
6.7%
Nasopharyngitis
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
10%
PLACEBO
(n=60) n (%)
3.3%
Conjunctivitisd
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
6.7%
PLACEBO
(n=60) n (%)
3.3%
Vomiting
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
5%
PLACEBO
(n=60) n (%)
6.7%
Pyrexia
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
5%
PLACEBO
(n=60) n (%)
6.7%
Abdominal Pain
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
1.7%
PLACEBO
(n=60) n (%)
3.3%
Diarrhea
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
1.7%
PLACEBO
(n=60) n (%)
1.7%
Molluscum contagiosum
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
1.7%
PLACEBO
(n=60) n (%)
0%
Bronchitis
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
1.7%
PLACEBO
(n=60) n (%)
0%
Pharyngitis streptococcal
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
0%
PLACEBO
(n=60) n (%)
3.3%
Erythema
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
3.3%
PLACEBO
(n=60) n (%)
0%
Alopecia
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
3.3%
PLACEBO
(n=60) n (%)
0%
Skin papilloma
DUPIXENT 300 mg
Q4W + TCS
(n=60) n (%)
3.3%
PLACEBO
(n=60) n (%)
0%
Upper respiratory tract infection
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
8.5%
PLACEBO
(n=60) n (%)
11.7%
Injection site reaction
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
13.6%
PLACEBO
(n=60) n (%)
5%
Nasopharyngitis
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
3.4%
PLACEBO
(n=60) n (%)
10%
Conjunctivitisd
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
8.5%
PLACEBO
(n=60) n (%)
5%
Vomiting
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
6.8%
PLACEBO
(n=60) n (%)
6.7%
Pyrexia
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
1.7%
PLACEBO
(n=60) n (%)
0%
Abdominal Pain
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
3.4%
PLACEBO
(n=60) n (%)
1.7%
Diarrhea
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
3.4%
PLACEBO
(n=60) n (%)
1.7%
Molluscum contagiosum
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
3.4%
PLACEBO
(n=60) n (%)
1.7%
Bronchitis
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
3.4%
PLACEBO
(n=60) n (%)
0%
Pharyngitis streptococcal
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
3.4%
PLACEBO
(n=60) n (%)
1.7%
Erythema
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
1.7%
PLACEBO
(n=60) n (%)
0%
Alopecia
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
0%
PLACEBO
(n=60) n (%)
0%
Skin papilloma
DUPIXENT 200 mg
Q2W + TCS
(n=59) n (%)
0%
PLACEBO
(n=60) n (%)
0%

aConjunctivitis cluster includes conjunctivitis bacterial, conjunctivitis, conjunctivitis allergic, conjunctivitis viral, and eye irritation.

Numerically fewer children treated with DUPIXENT + TCS developed skin infections compared with placebo + TCS in Trial 83

  • 7% of children <30 kg treated with DUPIXENT 300 mg Q4W + TCS and 9% of children ≥30 kg treated with DUPIXENT 200 mg Q2W + TCS vs 13% with placebo + TCS

Long-term safety profile observed in children

The long-term safety of DUPIXENT + TCS in children was assessed in an open-label extension study (Trial 7)1

  • The safety profile through Week 52 was similar to the safety profile observed through Week 16 in Trial 8
  • The long-term safety profile of DUPIXENT + TCS in children was consistent with that seen in adults and adolescents
DUPIXENT demonstrated a generally consistent safety profile across multiple age populations as young as 6 years of age1
Discontinuation rates due to adverse events in children treated with DUPIXENT + TCS were comparable to those with placebo + TCS2,b
  • 0.8% of children treated with DUPIXENT + TCS (n=242) discontinued treatment through Week 16 vs 1.7% of children treated with placebo + TCS (n=120) discontinued treatment through Week 16 (Trial 8)

bAnalysis 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

Avoid use of live vaccines in patients treated with DUPIXENT1

Important considerations

NO BOXED WARNING1

SELECT IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

  • Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum, anaphylaxis and serum sickness or serum sickness-like reactions, were reported in <1% of subjects who received DUPIXENT in clinical trials. 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 and vaccine information in the Drug Interactions section of 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

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

References:

  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals.
  3. 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.

Important Safety
Information and Indication

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

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum, anaphylaxis and serum sickness or serum sickness-like reactions, were reported in <1% of subjects who received DUPIXENT in clinical trials. 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. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.

Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical or inhaled corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. 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 Comorbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

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.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1% at Week 16) in adult patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile in children and adolescents 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 in adolescents and children observed through Week 52 was consistent with that seen in adults with atopic dermatitis.

DRUG INTERACTIONS: Avoid use of live vaccines in patients treated with DUPIXENT.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or obtain information about the registry. 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 patients aged 6 years 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.