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
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
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
ADVERSE REACTIONS: The most common adverse
reactions (incidence ≥1%) in patients with CRSwNP are injection site
reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
- 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
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
Chronic rhinosinusitis with nasal polyposis
(CRSwNP): DUPIXENT is indicated as an add-on maintenance treatment in adult patients
with inadequately controlled CRSwNP.
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.
DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately
controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).