Safety Data

Adverse reactions in the asthma population

The safety population (Trials 1 and 2) was 12-87 years of age, of which 63% were female and 82% were white. DUPIXENT 200 mg or 300 mg was administered subcutaneously Q2W, following an initial dose of 400 mg or 600 mg, respectively.

In Trials 1 and 2, the proportion of subjects who discontinued treatment due to adverse events was 4% of the placebo + SOC group, 3% of the DUPIXENT 200 mg Q2W + SOC group, and 6% of the DUPIXENT 300 mg Q2W + SOC group.

Adverse reactions occurring in ≥1% of DUPIXENT + SOC patients and at a higher rate than placebo
+ SOC in Trials 1 and 2 (6-month safety pool)

Adverse Reaction	DUPIXENT 200 mg Q2W + SOC n=779 n (%)	DUPIXENT 300 mg Q2W + SOC n=788 n (%)	Placebo + SOC n=792 n (%)
Injection site reactions^a	111 (14)	144 (18)	50 (6)
Oropharyngeal pain	13 (2)	19 (2)	7 (1)
Eosinophilia^b	17 (2)	16 (2)	2 (<1)

^aInjection site reactions cluster includes erythema, edema, pruritus, pain, and inflammation.

^bNone met the criteria for serious eosinophilic conditions.

Important Safety Information and Indications

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.

Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT. Conjunctivitis was the most frequently reported eye disorder in these patients. Among asthma subjects the frequency of conjunctivitis and keratitis was similar between DUPIXENT and placebo. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.

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. Be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in patients with eosinophilia, which may be associated with a reduction of oral corticosteroids. Cases of eosinophilic pneumonia and of vasculitis consistent with eosinophilic granulomatosis with polyangiitis have been reported in adult patients who participated in the asthma 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.

Atopic Dermatitis Patients with Comorbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

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:

Atopic Dermatitis: The most common adverse reactions (incidence ≥1%) are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.
Asthma: The most common adverse reactions (incidence ≥1%) 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: 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.

Indications

Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

Asthma: 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.

Adverse reactions in the asthma population

Adverse reactions occurring in ≥1% of DUPIXENT + SOC patients and at a higher rate than placebo
+ SOC in Trials 1 and 2 (6-month safety pool)

Specific adverse reactions in the asthma clinical trials

Hypersensitivity Reactions

Eosinophils

Cardiovascular

DRUG INTERACTIONS

Live Vaccines

DUPIXENT MyWay®

LEARN MORE ABOUT DUPIXENT

Safety Data

Adverse reactions in the asthma population

Adverse reactions occurring in ≥1% of DUPIXENT + SOC patients and at a higher rate than placebo + SOC in Trials 1 and 2 (6-month safety pool)

Specific adverse reactions in the asthma clinical trials

Hypersensitivity Reactions

Eosinophils

Cardiovascular

DRUG INTERACTIONS

Live Vaccines

DUPIXENT MyWay®

LEARN MORE ABOUT DUPIXENT

Adverse reactions occurring in ≥1% of DUPIXENT + SOC patients and at a higher rate than placebo
+ SOC in Trials 1 and 2 (6-month safety pool)