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, erythema multiforme, anaphylaxis and serum sickness or serum sickness-like reactions, were reported in
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.
Risk Associated with Abrupt 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
USE IN SPECIFIC POPULATIONS
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
Please see accompanying full Prescribing
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.