- Moderate-to-severe atopic dermatitis not controlled by other prescription therapies or when these therapies cannot be used (with or without topical corticosteroids).
- Add-on maintenance treatment of moderate-to-severe asthma that is of an eosinophilic phenotype or that is dependent on oral corticosteroids.
- Add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyposis.
Monoclonal antibody that inhibits interleukin-4 (IL-4) and IL-13, which inhibits cytokine-induced inflammatory responses. Mechanism in asthma not fully established.
- Decreased severity of atopic dermatitis.
- Decreased incidence of asthma exacerbations
- Reduction in nasal polyps and nasal congestion.
Absorption: 61–64% absorbed following subcut administration.
Distribution: Minimally distributed to tissues.
Metabolism and Excretion: Degraded by proteolytic enzymes located throughout the body.
TIME/ACTION PROFILE (plasma concentrations)
- Acute bronchospasm or status asthmaticus.
Use Cautiously in:
- Pre-existing helminth infections;
- OB: Use only if potential maternal benefit outweighs potential fetal risk;
- Lactation: Use only if potential maternal benefit outweighs potential risk to child;
- Pedi: Children <12 yr (safety and effectiveness not established).
Adverse Reactions/Side Effects
EENT: conjunctivitis, keratitis
Resp: eosinophilic pneumonia
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, RASH, ERYTHEMA NODOSUM, AND SERUM SICKNESS), injection site reactions
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Avoid use of live vaccines.
SC (Adults and Children ≥12 yr and ≥60 kg): 600 mg (given as two 300–mg injections) initially, then 300 mg in 2 wk, then 300 mg every 2 wk.
SC (Children ≥12 yr and <60 kg): 400 mg (given as two 200–mg injections) initially, then 200 mg in 2 wk, then 200 mg every 2 wk.
SC (Adults and Children ≥12 yr): 400 mg (given as two 200–mg injections) initially, then 200 mg in 2 wk, then 200 mg every 2 wk or 600 mg (given as two 300–mg injections) initially, then 300 mg in 2 wk, then 300 mg every 2 wk. Patients with oral corticosteroid-dependent asthma or concomitant moderate-to-severe atopic dermatitis– 600 mg (given as two 300–mg injections) initially, then 300 mg in 2 wk, then 300 mg every 2 wk.
Chronic Rhinosinusitis with Nasal Polyposis
SC (Adults): 300 mg every 2 wk.
Solution for injection (prefilled syringes): 300 mg/2 mL, 200 mg/1.14 mL
- Monitor for signs and symptoms of hypersensitivity reactions (rash, urticaria, erythema nodosum, serum sickness) during therapy. If severe reaction occurs, treat symptomatically and discontinue dupilumab.
- Monitor for signs and symptoms of conjunctivitis and keratitis (eye redness or irritation) periodically during therapy.
- Monitor lung sounds periodically during therapy.
- Monitor for signs and symptoms of rhinosinusitis periodically during therapy.
- SC Dose must be divided into two injections for 400 mg and 600 mg doses. Administer at different sites. Thigh and abdomen may be used if patient administers dose. May also use upper arm if administered by caregiver. Rotate site with each injection; do not inject in skin that is tender, damaged, bruised, or scarred. Allow solution to reach room temperature (45 min for 300 mg dose, 30 min for 200 mg dose) before injecting. Solution is clear to slightly opalescent, colorless to pale yellow; do not administer solutions that are cloudy, discolored, or contain particulate matter.
- Instruct patient and caregiver in correct injection technique and disposal of equipment. Administer missed dose as soon as remembered if within 7 days, then resume original schedule. If longer than 7 days, skip dose and resume with next scheduled dose.
- Inform patient that dupilumab is not used for acute asthma symptoms or exacerbations. Instruct patient to notify health care professional if asthma symptoms remain uncontrolled or worsen after starting dupilumab therapy.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
- Advise patient to avoid live vaccines during therapy.
- Advise patient to have helminth infections treated before starting dupilumab therapy.
- Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breast feeding.
- Decreased severity of atopic dermatitis.
- Decreased incidence of asthma exacerbations.
- Reduction in symptoms of chronic rhinosinusitis with nasal polyposis.
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