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
<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.
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.
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
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: 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 as an add-on maintenance treatment of patients 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.