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, anaphylaxis and serum sickness or serum sickness-like reactions, were reported in <1% of subjects who
received DUPIXENT in clinical trials. If a clinically significant hypersensitivity reaction occurs, institute
appropriate therapy and discontinue DUPIXENT.
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. Physicians
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 patients who
participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with
DUPIXENT in adult patients who participated in the asthma development program as well as in adult patients with
co-morbid asthma in the chronic rhinosinusitis with nasal polyposis 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.
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.
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%) in patients with asthma are injection site
reactions, oropharyngeal pain, and eosinophilia.
DRUG INTERACTIONS: Avoid use of live vaccines in
patients treated with DUPIXENT.
USE IN SPECIFIC POPULATIONS
- Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to DUPIXENT during pregnancy. Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or obtain information
about the registry. 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 Information.
DUPIXENT is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and
older with 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.