ADOLESCENT SAFETY PROFILE

For the treatment of adolescents (12-17 years) with uncontrolled moderate-to-severe atopic dermatitis,

Safety profile demonstrated up to Week 16

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

The long-term safety of DUPIXENT in adolescents (and children) was assessed in an open-label extension trial (AD-1434) through Week 521

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

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 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 KIDNEYS1

  • 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

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 Indications

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

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.

Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT compared to those who received placebo, with conjunctivitis being the most frequently reported eye disorder. Conjunctivitis also occurred more frequently in chronic rhinosinusitis with nasal polyposis subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

Eosinophilic Conditions: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA), conditions which are often treated with systemic corticosteroid therapy. These events may be associated with the reduction of oral corticosteroid therapy. Healthcare providers should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adult subjects who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult subjects who participated in the asthma development program as well as in adult subjects with co-morbid asthma in the CRSwNP development program. A causal association between DUPIXENT and these conditions has not been established.

Acute Asthma Symptoms or Deteriorating Disease: Do not use DUPIXENT to treat acute asthma symptoms, acute exacerbations, acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of DUPIXENT.

Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Patients with Co-morbid Asthma: Advise patients with atopic dermatitis or CRSwNP who have co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.

Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

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. Helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old in the pediatric asthma development program.

Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

ADVERSE REACTIONS:
  • Atopic dermatitis: The most common adverse reactions (incidence ≥1% at Week 16) in adult patients 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.
  • Asthma: The most common adverse reactions (incidence ≥1%) are injection site reactions, oropharyngeal pain, and eosinophilia.
  • Chronic rhinosinusitis with nasal polyposis: The most common adverse reactions (incidence ≥1%) are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
USE IN SPECIFIC POPULATIONS
  • Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. 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.


Indications

Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric 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.

Asthma: DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.

Chronic rhinosinusitis with nasal polyposis (CRSwNP): DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled CRSwNP.