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Dupilumab

Brand and Other Names: DUPIXENT®
Mechanism of Action:

Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4R⍺ subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor.

Inflammation driven by IL-4 and IL-13 is an important component in the pathogenesis of asthma, atopic dermatitis (AD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis (PN), chronic obstructive pulmonary disease (COPD), chronic spontaneous urticaria (CSU), and bullous pemphigoid (BP). Multiple cell types that express IL-4R⍺ (eg, mast cells, basophils, eosinophils, macrophages, lymphocytes, epithelial cells, goblet cells) and inflammatory mediators (eg, histamine, eicosanoids, leukotrienes, cytokines, chemokines) are involved in inflammation. Blocking IL-4R⍺ with dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The mechanism of dupilumab action has not been definitively established.

Indications:

Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months 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: DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitations of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus. Chronic Rhinosinusitis with Nasal Polyps: DUPIXENT is indicated as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps. Eosinophilic Esophagitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis. Prurigo Nodularis: DUPIXENT is indicated for the treatment of adult patients with prurigo nodularis. Chronic Obstructive Pulmonary Disease: DUPIXENT is indicated as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease and an eosinophilic phenotype. Limitations of Use: DUPIXENT is not indicated for the relief of acute bronchospasm. Chronic Spontaneous Urticaria: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: DUPIXENT is not indicated for treatment of other forms of urticaria. Bullous Pemphigoid: DUPIXENT is indicated for the treatment of adult patients with bullous pemphigoid (BP).

Route: Subcutaneous
Dose:

Dosage:

Atopic Dermatitis 

Dosage in Adults: Recommended dosage is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W). 

Recommended Dosage in Pediatric Patients 6 Months to 5 Years of Age:

Body Weight Initiala and Subsequent Dosage
5 to less than 15 kg 200 mg (one 200 mg injection) every 4 weeks (Q4W)
15 to less than 30 kg 300 mg (one 300 mg injection) Q4W

a For pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended.

Recommended Dosage in Pediatric Patients 6 Years of Age and Older:

Body Weight Initial Loading Dose Subsequent Dosage
15 to less than 30 kg 600 mg (two 300 mg injections) 300 mg Q4W
30 to less than 60 kg 400 mg (two 200 mg injections) 200 mg Q2W
60 kg or more 600 mg (two 300 mg injections) 300 mg Q2W

Asthma

Recommended Dosage in Adult and Pediatric Patients 12 Years and Older:

Initial Loading Dose Subsequent Dosage
400 mg (two 200 mg injections) 200 mg Q2W
Or
600 mg (two 300 mg injections) 300 mg Q2W
Dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyps
600 mg (two 300 mg injections) 300 mg Q2W

Recommended Dosage in Pediatric Patients 6 to 11 Years of Age:

Body Weight Initiala and Subsequent Dosage
15 to less than 30 kg 300 mg Q4W
≥30 kg 200 mg Q2W

a For pediatric patients 6 to 11 years of age with asthma, no initial loading dose is recommended.

For pediatric patients 6 to 11 years old with asthma and co-morbid moderate-to-severe atopic dermatitis, follow the recommended dosage as per Table for Atopic Dermatitis Dosage in Pediatric Patients 6 Years of Age and Older, which includes an initial loading dose.

Chronic Rhinosinusitis with Nasal Polyps

Recommended dosage for adult and pediatric patients 12 years of age and older is 300 mg given Q2W.

Eosinophilic Esophagitis

Recommended Dosage for Adult and Pediatric Patients 1 Year of Age and Older:

Body Weight Recommended Dosage 
15 to less than 30 kg 200 mg Q2W
30 to less than 40 kg 300 mg Q2W
40 kg or more 300 mg every week (QW)

Prurigo Nodularis

Recommended dosage for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given Q2W.

Chronic Obstructive Pulmonary Disease

Recommended dosage for adult patients is 300 mg given every 2 weeks (Q2W).

Chronic Spontaneous Urticaria

Dosage in Adults: Recommended dosage for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).

Recommended Dosage in Pediatric Patients 12 to 17 Years of Age with CSU:

Body Weight Initial Loading Dose Subsequent Dosage
30 to less than 60 kg 400 mg (two 200 mg injections) 200 mg every 2 weeks (Q2W)
60 kg or more 600 mg (two 300 mg injections) 300 mg every 2 weeks (Q2W)

Bullous Pemphigoid

Recommended dosage for adult patients is an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week (Q2W). Concomitant Oral Corticosteroids: Use DUPIXENT in combination with a tapering course of oral corticosteroids. Once disease control has occurred, gradually taper corticosteroids after which continue DUPIXENT as monotherapy. In case of relapse, corticosteroids may be added if medically advisable.

Adverse Reactions:

Most common adverse reactions are:

  • Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia
  • Asthma (incidence ≥1%): injection site reactions, oropharyngeal pain, and eosinophilia
  • Chronic Rhinosinusitis with Nasal Polyps (incidence ≥1%): injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis
  • Eosinophilic Esophagitis (incidence ≥2%): injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections
  • Prurigo Nodularis (incidence ≥2%): nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea
  • Chronic Obstructive Pulmonary Disease (incidence ≥2%): viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reactions, rhinitis, eosinophilia, toothache, and gastritis
  • Chronic Spontaneous Urticaria (incidence ≥2%): injection site reactions
  • Bullous Pemphigoid (incidence ≥2%): arthralgia, conjunctivitis, vision blurred, herpes viral infections, keratitis.
Contraindication:

DUPIXENT is contraindicated in patients who have known hypersensitivity to dupilumab or any excipients of DUPIXENT.

Warnings and Precautions:
  • Hypersensitivity: Hypersensitivity reactions including anaphylaxis, acute generalized exanthematous pustulosis (AGEP), serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme have occurred. Discontinue DUPIXENT in the event of a hypersensitivity reaction
  • Conjunctivitis and Keratitis: Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination, as appropriate
  • Eosinophilic Conditions: Be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, kidney injury and/or neuropathy, especially upon reduction of oral corticosteroids
  • Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Decrease steroids gradually, if appropriate
  • Psoriasis: Advise patients to report new-onset psoriasis symptoms to their healthcare provider. If symptoms persist or worsen, consider dermatologic evaluation and/or discontinuation of DUPIXENT
  • Arthralgia and Psoriatic Arthritis: Advise patients to report new onset joint symptoms to their healthcare provider. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT
  • Parasitic (Helminth) Infections: Treat pre-existing helminth infections before initiating DUPIXENT. If patients become infected while receiving DUPIXENT and do not respond to anti-helminth treatment, discontinue DUPIXENT until the infection resolves
  • Vaccinations: Avoid use of live vaccines
See package insert for full prescribing information.