Indicated for:

Atopic Dermatitis:

• The treatment of patients aged 6 years and older 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:

• 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.

DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.

Chronic Rhinosinusitis with Nasal Polyposis:

• Indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

Advise patients with atopic dermatitis or CRSwNP who have co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.

Conjunctivitis and keratitis occurred more frequently in subjects who received DUPIXENT. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis recovered or were recovering during the treatment period.

DUPIXENT-treated subjects had a greater mean initial increase from baseline in eosinophil count compared to subjects treated with placebo in the monotherapy trials.

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, conditions which are often treated with systemic corticosteroid therapy.

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.

Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum and serum sickness or serum sickness-like reactions, were reported in less than 1% of subjects who received DUPIXENT in clinical trials.

Development of antibodies to dupilumab was associated with lower serum dupilumab concentrations.

Reports of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes).

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.

Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of therapy with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician.

Patients with known helminth infections were excluded from participation in clinical studies. 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. 

Avoid use of live vaccines in patients treated with DUPIXENT.

Upon initiation or discontinuation of DUPIXENT in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

There are no available data on DUPIXENT use in pregnant women to inform any drug associated risk. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.

Human IgG is known to be present in human milk. The effects of local gastrointestinal and limited systemic exposure to dupilumab on the breastfed infant are unknown.

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• Use in patients under the age of 12 for asthma and in patients under the age of 6 for atopic dermatitis. GoToSource

• Acute asthma symptoms or exacerbations and acute bronchospasm or status asthmaticus. GoToSource

Transient elevation of blood eosinophils. GoToSource

Exacerbation of atopic dermatitis, nasopharyngitis, upper respiratory tract infection, conjunctivitis (inflammation or infection of the transparent membrane (conjunctiva) that lines eyelid and covers the white part of the eyeball), opportunistic infections (including herpes, furuncle, staphylococcal skin infection, impetigo, and body tinea), cystitis (inflammation of the bladder), gastroenteritis (inflammation of stomach and intestines) and hordeolum (localized infection or inflammation of the eyelid margin). GoToSource

Lawsuits filed for eosinophilia.