2024 ATS Conference News Preview - D

IMPORTANT SAFETY INFORMATION (cont'd)
WARNINGS AND PRECAUTIONS (cont'd)
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 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 during treatment 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.
An Innovation Hub presentation at the ATS 2024 International Conference. This workshop is sponsored by Sanofi and Regeneron.
Due to regulatory restrictions, this workshop is only available to attendees from the United States.
© 2024 Sanofi and Regeneron Pharmaceuticals, Inc. All Rights Reserved.
02/2024 US.DUP.24.01.0364
DUPIXENT®
is a registered trademark of
Sanofi Biotechnology.

https://www.dupixenthcp.com/

2024 ATS Conference News Preview

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