INDICATIONS
Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric
patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) 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. Limitations of Use: DUPIXENT
is not indicated for the relief of acute bronchospasm or status asthmaticus.
Chronic Rhinosinusitis with Nasal Polyps: DUPIXENT is indicated as an add-on
maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately
controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Eosinophilic Esophagitis: DUPIXENT is indicated for the treatment of adult and
pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
Prurigo Nodularis: DUPIXENT is indicated for the treatment of adult patients with
prurigo nodularis (PN).
Chronic Obstructive Pulmonary Disease: DUPIXENT is indicated as an add-on
maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary
disease (COPD) and an eosinophilic phenotype. Limitations of Use: DUPIXENT is not indicated for
the relief of acute bronchospasm.
IMPORTANT SAFETY
INFORMATION
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
AD subjects who received DUPIXENT versus placebo, with conjunctivitis being the most frequently reported
eye disorder. Conjunctivitis also occurred more frequently in adult CRSwNP subjects, PN subjects, and
COPD subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis and keratitis
have been reported with DUPIXENT in postmarketing settings, predominantly in AD patients. Some patients
reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise
patients or their caregivers 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 Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Acute Deteriorating
Disease: Do not use DUPIXENT to treat acute symptoms or acute exacerbations of asthma or
COPD, acute bronchospasm, or status asthmaticus. Patients should seek medical advice if their asthma or
COPD 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 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 during
treatment with DUPIXENT.
ADVERSE REACTIONS:
Most common adverse reactions are:
-
Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis,
blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye,
and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of
adults with AD. In an open-label extension study, the long-term safety profile of DUPIXENT ±
TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with AD,
with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months
to 5 years of age. These cases did not lead to study drug discontinuation.
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Asthma (incidence ≥1%): injection site reactions, oropharyngeal pain, and
eosinophilia.
-
Chronic Rhinosinusitis with Nasal Polyps (incidence ≥1% in adult patients):
injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and
conjunctivitis.
-
Eosinophilic Esophagitis (incidence ≥2%): injection site reactions, upper
respiratory tract infections, arthralgia, and herpes viral infections.
-
Prurigo Nodularis (incidence ≥2%): nasopharyngitis, conjunctivitis, herpes
infection, dizziness, myalgia, and diarrhea.
-
Chronic Obstructive Pulmonary Disease (incidence ≥2%): viral infection,
headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local
administration reactions, rhinitis, eosinophilia, toothache, and gastritis.
USE IN SPECIFIC POPULATIONS
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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