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
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
frequently reported eye disorder. Conjunctivitis also occurred more frequently in chronic rhinosinusitis with
polyposis subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis and keratitis
been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some
reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Advise patients
report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination
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.
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
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
acute exacerbations, acute bronchospasm or status asthmaticus. Patients should seek medical advice if their
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
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
disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization.
patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider
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
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
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
USE IN SPECIFIC POPULATIONS
- 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,
herpes simplex virus infection, and dry eye. The safety profile in children and adolescents through Week 16
similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety
of DUPIXENT in adolescents and children observed through Week 52 was consistent with that seen in adults
- 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
- 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
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.