Asthma (≥ 12 years old)
Atopic dermatitis (adults)
- Initial dose of 400 mg (two 200 mg injections) followed by 200 mg given every other week or an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given
every other week
- For patients with oral corticosteroid-dependent asthma or with moderate-to-severe atopic dermatitis, use the 300 mg dosing
- Initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week
- If a dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient's original schedule. If the missed dose is not
administered within 7 days, instruct the patient to wait until the next dose on the original schedule.
- Administer subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. The upper arm can also be used if a caregiver administers the injection.
- For initial dose, give injections at different sites
- Store in refrigerator
- If necessary, may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days
- Do not expose to light
- 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-4Rα 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 is an important component in the pathogenesis of asthma and atopic dermatitis. Multiple cell types that express IL-4Rα (e.g., mast cells, eosinophils,
macrophages, lymphocytes, epithelial cells, goblet cells) and inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines, chemokines) are involved in inflammation.
- Asthma - 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. In trials, a minimum blood eosinophil count was not required.
- Atopic dermatitis - 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. Dupilumab can be used with or without topical corticosteroids.
NOTE: P = % of patients on placebo who reported side effect. Only side effects that occurred at an incidence ≥ 1% are listed.
Atopic dermatitis trials
- Injection site reactions - 10%, P - 5%
- Conjunctivitis - 10%, P - 2%
- Oral herpes - 4%, P - 2%
- Other herpes infections - 2%, P - 1%
- Eye itching - 1%, P - <1%
Asthma trials (300 mg dose)
- Injection site reactions - 18%, P - 6%
- Oropharyngeal pain - 2%, P - 1%
- Blood eosinophilia (≥ 3000 cells/mcL) - 2%, P - <1%
- No clinically relevant drug interactions have been documented
- Hypersensitivity reactions - in trials, hypersensitivity reactions occurred in < 1% of dupilumab-treated patients. Reactions included
generalized urticaria, rash, erythema nodosum and serum sickness or serum sickness-like reactions.
- Conjunctivitis and keratitis - in atopic dermatitis trials, conjunctivitis occurred in 10% of dupilumab-treated
patients and 2% of placebo-treated patients. Keratitis was reported in 4% of dupilumab-treated patients and 0% of placebo-treated patients. Patients should be advised to report eye symptoms
to their provider.
- Eosinophilic conditions - cases of eosinophilic pneumonia and cases of vasculitis consistent with eosinophilic granulomatosis with polyangiitis
have been reported in asthmatics being treated with dupilumab. A causal relationship between dupilumab and these conditions has not been established.
- Eosinophilia - dupilumab may raise serum eosinophil levels. In asthma trials, the average increase in the eosinophil count was 130 cells/mcL at
4 weeks of treatment. Treatment-emergent eosinophilia (≥5,000 cells/mcL) was reported in < 2% of dupilumab-treated patients and < 0.5% in placebo-treated patients.
Blood eosinophil counts declined to near baseline levels during study treatment.
- Acute bronchospasm - dupilumab does not treat acute bronchospasm
- Reduction of corticosteroids - do not abruptly stop oral, inhaled, or topical corticosteroids when starting dupilumab. Reductions in
corticosteroids should be done gradually to prevent withdrawal symptoms.
- Parasitic (Helminth) infections - dupilumab may increase the risk of geohelminthic infections (roundworm, hookworm, whipworm, threadworm).
Known helminth infections should be treated before initiating therapy. If patients become infected while on dupilumab and they do not respond to anti-helminth therapy, dupilumab
should be stopped.
- Anti-dupilumab antibodies - in trials, anti-dupilumab antibodies developed in up to 9% of dupilumab-treated patients. In some patients,
antibodies were associated with lower serum levels of dupilumab. Two patients with high titer antibodies developed serum sickness.
- Vaccines - avoid live vaccines in patients receiving dupilumab.
See live vaccines for more. In trials, antibody responses to non-live vaccines were not reduced in
- Liver disease - has not been studied
- Kidney disease - has not been studied