DUPIXENT is the first and only FDA-approved treatment indicated for eosinophilic esophagitis, or EoE, in patients aged 12 years and older weighing at least 40 kilograms. EoE is a chronic condition that is rapidly increasing in prevalence.

It is caused primarily by type 2 inflammation, which if left uncontrolled can lead to remodeling of the esophagus and disease progression.

Type 2 inflammation in EoE is driven by multiple cell types and mediators, and central to this pathway are Th2 cells.

Th2 cells secrete IL-4 and IL-13, key cytokines that perpetuate type 2 inflammation in multiple ways.

First, IL-4 drives Th2 cell proliferation and differentiation, amplifying the release of type 2 cytokines.

Second, IL-4 and IL-13 facilitate the disruption of the junctions between epithelial cells, compromising epithelial barrier integrity.

Third, IL-4 and IL-13 contribute to the recruitment of eosinophils into the tissue.

In the inflammatory process, IL-4 binds to both type I and type II receptor complexes, while IL-13 binds to type II receptor located on the surface of multiple cell types, and upon receptor binding lead to unique intracellular signaling.

DUPIXENT binds to the IL-4 receptor alpha subunit of the type I and type II receptors and blocks IL-4 and IL-13 signaling—helping to stop the pathological process of EoE.

Suppression of IL-4 and IL-13 signaling has been associated with inhibition of Th2 cell differentiation and proliferation, reduced eosinophil trafficking, and improved epithelial barrier function.

DUPIXENT is a dual inhibitor of IL-4 and IL-13 signaling and addresses the type 2 inflammation underlying EoE. It is not an immunosuppressant.

As the first and only FDA-approved treatment for EoE, DUPIXENT is transforming the treatment of this chronic, progressive disease.

Full Important Safety Information

IMPORTANT SAFETY 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 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.

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.

Patients with Co-morbid Asthma: Advise patients with co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.

Arthralgia: Arthralgia has been reported with the 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 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.

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 ≥2%) are injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.

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.

INDICATION

DUPIXENT is indicated for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE).