Adolescent Safety Profile

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

The long-term safety of DUPIXENT in adolescents (and children) was assessed in an open-label extension trial (Trial 7) through Week 521

Adolescent safety demonstrated up to Week 161

Adverse reactions in ≥2% of patients during the 16-week treatment period and higher rate with DUPIXENT2,3
Conjunctivitisd
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
10%
PLACEBO
(n=85) n (%)
5%
Injection site reaction
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
9%
PLACEBO
(n=85) n (%)
4%
Gastroenteritis viral
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
4%
PLACEBO
(n=85) n (%)
1%
Pharyngitis streptococcal
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
2%
PLACEBO
(n=85) n (%)
0%
Viral upper respiratory tract infection
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
2%
PLACEBO
(n=85) n (%)
1%
Bronchitis
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
2%
PLACEBO
(n=85) n (%)
0%
Sinusitis bacterial
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
2%
PLACEBO
(n=85) n (%)
0%
Fatigue
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
2%
PLACEBO
(n=85) n (%)
0%
Oropharyngeal pain
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
2%
PLACEBO
(n=85) n (%)
1%
Nausea
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
2%
PLACEBO
(n=85) n (%)
1%
Abdominal pain upper
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
2%
PLACEBO
(n=85) n (%)
1%
Ligament sprain
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
2%
PLACEBO
(n=85) n (%)
0%
Procedural pain
DUPIXENT 200 mg
or 300 mg Q2W
(n=82) n (%)
2%
PLACEBO
(n=85) n (%)
0%

aIncludes atopic keratoconjunctivitis, conjunctivitis, conjunctivitis allergic, conjunctivitis bacterial, and conjunctivitis viral.

Numerically fewer adolescent patients treated with DUPIXENT developed skin infections compared
with placebo in Trial 6 (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 (Trial 7) through Week 521
  • The safety profile of DUPIXENT through Week 16 and Week 52 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 (Trial 6)

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 infections

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, Inc.
  3. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44-56.

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.