ATS 2022 Conference News Preview - Insert 3B

IMPORTANT SAFETY INFORMATION (cont'd)
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.
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 comorbid 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 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.
Arthralgia: Arthralgia has been reported with 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 the 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 DUPIXENT.
ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with asthma are injection
site reactions, oropharyngeal pain, and eosinophilia.
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 Information in pocket.
© 2022 Sanofi and Regeneron Pharmaceuticals, Inc. All Rights Reserved.
03/2022 DUP.22.02.0104
DUPIXENT®
is a registered trademark of
Sanofi Biotechnology.

http://www.dupixenthcp.com/asthma/congress https://www.mothertobaby.org/

ATS 2022 Conference News Preview

Table of Contents for the Digital Edition of ATS 2022 Conference News Preview