Version July 2025
Asthma, moderate to severe eosinophilic phenotype or oral glucocorticoid dependent: Note: May be used as add-on therapy in patients with eosinophilic asthma that is inadequately controlled on standard therapies (eg, high-dose inhaled corticosteroid and long-acting beta agonist) who have an eosinophilic phenotype (eg, peripheral blood eosinophils ≥150 cells/mcL) and/or other coexisting type 2 inflammatory conditions (eg, atopic dermatitis, rhinosinusitis with nasal polyposis) that require cotreatment (Ref). A minimum of 4 months of treatment is suggested to determine efficacy (Ref).
SUBQ: 400 mg once, followed by 200 mg every other week.
OR
SUBQ: 600 mg once, followed by 300 mg every other week. Note: Preferred dosing for patients with glucocorticoid-dependent asthma and type 2 inflammatory conditions (Ref).
Atopic dermatitis, moderate to severe: Note: For use as add-on therapy in patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
SUBQ: 600 mg once, followed by 300 mg once every other week. In patients controlled after 1 year of initial therapy, may consider extending dosing intervals to every 3 to 4 weeks (Ref).
Chronic obstructive pulmonary disease, refractory (prevention of exacerbations): Note: May be preferred systemic add-on therapy in patients with refractory eosinophilic chronic obstructive pulmonary disease (peripheral blood eosinophils ≥300 cells/mcL) who experience frequent exacerbations despite maximal standard therapies (eg, an inhaled glucocorticoid, long-acting beta-agonist and long-acting muscarinic antagonist) (Ref). Discontinue therapy after 6 to 12 months if not effective (Ref).
SUBQ: 300 mg once every other week (Ref).
Eosinophilic esophagitis: Note: Some experts reserve for patients with comorbid atopic conditions (eg, severe asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps) or those who are refractory to or decline other treatments (Ref).
SUBQ: 300 mg once weekly.
Prurigo nodularis: Note: Recommended first-line systemic treatment for widespread or refractory disease (Ref).
SUBQ: 600 mg once, followed by 300 mg once every other week.
Rhinosinusitis, chronic, with nasal polyps:
Note: May consider as add-on therapy in patients not controlled with other therapy (including intranasal corticosteroids and/or surgery) (Ref). A minimum of 6 months of treatment is suggested to determine efficacy (Ref).
SUBQ: 300 mg once every other week. In patients who have complete control of symptoms, some experts consider extending dosing intervals to every 4 weeks (Ref).
Urticaria, chronic spontaneous: SUBQ: 600 mg once, followed by 300 mg once every other week.
Missed doses: If a weekly dose is missed, administer the dose as soon as possible, and start a new weekly schedule from the date of the last administered dose. If an every-other-week dose is missed, administer within 7 days from the missed dose and then resume the original schedule. If the missed dose is not administered within 7 days, wait until the next dose on the original schedule.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Dupilumab: Pediatric drug information")
Dosage guidance:
Safety: Dosing interval varies by age and indication (eg, every week, every other week, every 4 weeks); use caution. Patients should be current with all age-appropriate immunizations prior to initiation.
Asthma (moderate to severe), maintenance therapy:
Children 6 to <12 years: Prefilled pen, prefilled syringe:
Note: In children 6 to <12 years, an initial loading dose is not necessary. If patient has atopic dermatitis comorbidity, the dosing for atopic dermatitis (including the initial loading dose) should be used to determine dupilumab therapy.
15 to <30 kg: SUBQ: 300 mg every 4 weeks or 100 mg every other week. Note: The 100 mg biweekly dose was previously described in manufacturer labeling; however, it has been removed from the market, no longer appears in labeling, and cannot be achieved with currently available dosage forms (Ref).
≥30 kg: SUBQ: 200 mg every other week.
Children ≥12 years and Adolescents: Prefilled pen, prefilled syringe: SUBQ: Initial: 400 mg once (administered as two 200 mg injections), followed by a maintenance dose of 200 mg every other week or 600 mg once (administered as two 300 mg injections), followed by a maintenance dose of 300 mg every other week.
Corticosteroid-dependent asthma or comorbid moderate to severe atopic dermatitis: Prefilled pen, prefilled syringe: SUBQ: Initial: 600 mg once (administered as two 300 mg injections), followed by a maintenance dose of 300 mg every other week.
Atopic dermatitis, moderate to severe: Note: May be used in combination with topical corticosteroids or topical calcineurin inhibitors; reserve calcineurin inhibitors for problem areas such as the face, neck, intertriginous, and genital areas.
Infants ≥6 months and Children <6 years: Note: Prefilled syringe may be used in ages ≥6 months; prefilled pen is only for use in ages ≥2 years. An initial loading dose is not necessary in pediatric patients <6 years.
5 to <15 kg: SUBQ: 200 mg every 4 weeks.
15 to <30 kg: SUBQ: 300 mg every 4 weeks.
Children ≥6 years and Adolescents ≤17 years: Prefilled pen, prefilled syringe:
15 to <30 kg: SUBQ: Initial: 600 mg once (administered as two 300 mg injections), followed by a maintenance dose of 300 mg every 4 weeks.
30 to <60 kg: SUBQ: Initial: 400 mg once (administered as two 200 mg injections), followed by a maintenance dose of 200 mg every other week.
≥60 kg: SUBQ: Initial: 600 mg once (administered as two 300 mg injections), followed by a maintenance dose of 300 mg every other week.
Adolescents ≥18 years: Prefilled pen, prefilled syringe: SUBQ: Initial: 600 mg once (administered as two 300 mg injections), followed by a maintenance dose of 300 mg every other week.
Eosinophilic esophagitis: Note: Prefilled syringe may be used in all approved ages; the prefilled pen is only for use in ages ≥2 years.
Children and Adolescents:
15 to <30 kg: SUBQ: 200 mg every other week.
30 to <40 kg: SUBQ: 300 mg every other week.
≥40 kg: SUBQ: 300 mg every week.
Rhinosinusitis (chronic) with nasal polyps: Children ≥12 years and Adolescents: SUBQ: 300 mg once every other week.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Various dermatologic and hypersensitivity reactions have been reported, including skin rash, urticaria, erythema multiforme, erythema nodosum, angioedema, and serum sickness-like reaction (Ref). Other reactions have also been reported, including alopecia (areata), facial erythema, immune thrombocytopenia purpura, psoriasis, and Sweet syndrome (Ref).
Mechanism: Immediate hypersensitivity reactions (urticaria/angioedema): Non-dose-related; likely immunologic (ie, IgE-mediated, with specific antibodies formed against a drug allergen following initial exposure) or due to histamine-releasing activity (Ref). Serum sickness-like reaction: Associated with high titers of antibodies to dupilumab. Alopecia areata, psoriasis: Unknown; alteration of immune signaling may upregulate T-helper type 1 (Th1) and Th17 pathways (Ref). Facial erythema: Unknown; proposed theories include hypersensitivity reaction, paradoxical flaring of allergic contact dermatitis, and seborrheic dermatitis-like reaction to facial Malassezia species (Ref).
Onset: Rapid; immediate hypersensitivity reactions; generally occur within 1 hour of administration, but have been reported 1 month after dupilumab injection (Ref). Delayed; serum sickness-like reaction occurred 10 days after first injection (Ref). Facial or neck erythema occurred an average of 11 weeks after initiation (Ref). Varied; alopecia areata has occurred 48 hours after the first injection up to 28 months of treatment (Ref). Psoriasis has occurred 1 month to 18 months after initiation (Ref).
Ocular surface disorders, including conjunctivitis, blepharitis, keratitis, eye pruritus, and dry eye syndrome have been reported (Ref). Although most cases are mild to moderate with resolution occurring in 80% of cases despite continued treatment with dupilumab (Ref), cases of severe cicatrizing blepharoconjunctivitis have also been reported (Ref).
Mechanism: Unknown; one possible mechanism includes reduction in ocular cytokines provides environment for Demodex mites to grow, resulting in IL-17-mediated inflammation, eosinophilia, and systemic IL-13 inhibition indirectly leading to reduction in conjunctival goblet cells and mucin production, contributing to tear film insufficiencies and subsequent corneal erosions (Ref). Other possible mechanisms include unmasking of preexistent subclinical atopic or allergic inflammatory processes, increased expression of proinflammatory molecules (ie, OX40L), and a local immunodeficiency resulting in local bacterial and viral infections (Ref).
Onset: Varied; 2 weeks to ~4 months after initiation (Ref).
Risk factors:
• Severe atopic dermatitis (Ref). No increase in incidence of conjunctivitis in dupilumab-treated asthma, chronic rhinosinusitis with nasal polyps, or eosinophilic esophagitis (Ref)
• Previous history of allergic conjunctivitis (Ref)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adolescents and adults unless otherwise specified.
>10%:
Hematologic & oncologic: Eosinophilia (≥500 cells/mcL: 42%; ≥1,000 cells/mcL: 2% to 14%; ≥5,000 cells/mcL: <3%)
Immunologic: Antibody development (1% to 16%; neutralizing: 1% to 5%)
Infection: Viral infection (adults: 14%)
Local: Injection-site reaction (1% to 38%)
Respiratory: Upper respiratory tract infection (18%)
1% to 10%:
Gastrointestinal: Diarrhea (adults: 3% to 4%), gastritis (adults: 2%), toothache (adults: 1% to 2%)
Genitourinary: Urinary tract infection (adults: 3%)
Infection: Helminthiasis (children: 2%; including ascariasis, enterobiasis), herpes virus infection (≤4%; including herpes simplex infection, herpes zoster infection [including ophthalmic herpes zoster], oral herpes simplex infection)
Nervous system: Dizziness (adults: 3%), headache (adults: 8%), insomnia (adults: 1%)
Neuromuscular & skeletal: Arthralgia (2% to 3%), back pain (adults: 5%), myalgia (adults: 3%)
Ophthalmic: Conjunctivitis (adults: 1% to 10%) (table 1), eye pruritus (adults: 1%) (table 2)
|
Drug (Dupilumab) |
Placebo |
Population |
Dose |
Indication |
Number of Patients (Dupilumab) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|
|
10% |
2% |
Adults |
300 mg given every other week |
Atopic dermatitis |
529 |
517 |
|
1% |
1% |
Adults |
300 mg given every other week |
Chronic obstructive pulmonary disease |
938 |
934 |
|
2% |
1% |
Adults |
300 mg given every other week |
Chronic rhinosinusitis with nasal polyposis |
440 |
282 |
|
4% |
1% |
Adults |
300 mg given every other week |
Prurigo nodularis |
152 |
157 |
|
Drug (Dupilumab) |
Placebo |
Population |
Dose |
Indication |
Number of Patients (Dupilumab) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|
|
1% |
0.2% |
Adults |
300 mg given every other week |
Atopic dermatitis |
529 |
517 |
Respiratory: Nasopharyngitis (adults: 5% to 8%), oropharyngeal pain (2%), rhinitis (adults: 3%)
<1%:
Cardiovascular: Thromboembolic complications (adults: acute myocardial infarction, cerebrovascular accident)
Gastrointestinal: Cholecystitis (severe; adults)
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, serum sickness, serum sickness-like reaction)
Ophthalmic: Dry eye syndrome (adults), keratitis (adults)
Postmarketing (any population):
Cardiovascular: Aortic aneurysm (age ≥75 years) (Ref), eosinophilic granulomatosis with polyangiitis (Ref), vasculitis (including hypersensitivity angiitis) (Ref)
Dermatologic: Acne vulgaris (Ref), acute generalized exanthematous pustulosis (Ref), alopecia (areata) (Ref), burning sensation of skin (Ref), desquamation (Ref), discoloration of sweat (infectious pseudochromhidrosis) (Ref), erythema multiforme (Ref), erythema nodosum (Ref), erythema of skin, facial erythema (Ref), facial rash, papule of skin, pruritus (Ref), psoriasis (including nail psoriasis, pustular psoriasis) (Ref), rosacea-like face eruption (Ref), skin pain, skin rash, Sweet syndrome (Ref), vitiligo (Ref)
Gastrointestinal: Pancreatitis (Ref)
Hematologic & oncologic: Hodgkin lymphoma (Ref), immune thrombocytopenia (Ref), T-cell lymphoma (including cutaneous) (Ref)
Hypersensitivity: Angioedema (Ref), facial edema
Immunologic: Sarcoidosis (sarcoid-like granulomatosis and [neuro]sarcoid-like reaction) (Ref)
Infection: Influenza (Ref)
Nervous system: Sleep disturbance (including nocturnal dyspnea) (Ref)
Neuromuscular & skeletal: Arthritis (including psoriatic arthritis, seronegative arthritis) (Ref), arthropathy (enthesitis and enthesopathy) (Ref), joint swelling (Ref)
Ophthalmic: Blepharitis (Ref), blepharoconjunctivitis (Ref), conjunctival scarring (Ref), corneal perforation (Ref), corneal ulcer (Ref), eye irritation (Ref), iridocyclitis (Ref), keratoconjunctivitis (Ref), keratoconus (Ref), punctate keratitis (Ref)
Respiratory: Eosinophilic pneumonitis (Ref), epistaxis (Ref), pulmonary alveolar hemorrhage (Ref)
Miscellaneous: Granuloma (annulare) (Ref)
Known hypersensitivity to dupilumab or any component of the formulation
Concerns related to adverse effects:
• Arthralgia and psoriatic arthritis: Arthralgia, including gait disturbances or decreased mobility associated with joint symptoms, has been reported, sometimes requiring hospitalization. May occur within days to months following initiation of therapy and has resolved with or without therapy discontinuation; psoriatic arthritis requiring treatment has been reported; symptoms resolved with and without therapy discontinuation; report new-onset or worsening joint symptoms to health care provider.
• Eosinophilia and vasculitis: In rare cases, patients may present with clinical features of eosinophilic pneumonia or eosinophilic granulomatosis with polyangiitis. Monitor for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, kidney injury, and/or neuropathy, especially upon reduction of oral corticosteroids. A causal association between dupilumab and these underlying conditions has not been established.
Disease-related concerns:
• Helminth infections: It is unknown if administration of dupilumab will influence a patient's response against parasitic infections; patients with known helminth infections were not studied. Adverse reactions of helminth infections were reported in pediatric patients 6 to 11 years of age who participated in the pediatric asthma development program. Therefore, patients with preexisting helminth infections should undergo treatment of the infection prior to initiation of dupilumab therapy. Patients who become infected during treatment and do not respond to anti-helminth therapy should discontinue dupilumab until the infection resolves.
• Psoriasis: Patients treated for atopic dermatitis and asthma have reported new-onset psoriasis, some with a family history of psoriasis. May occur weeks to months following initiation of therapy and resolved with and without discontinuation of therapy; patients maintained on dupilumab may require treatment of psoriasis symptoms.
Concurrent drug therapy issues:
• Corticosteroid therapy: Do not discontinue corticosteroids abruptly following initiation of dupilumab therapy. Reductions in corticosteroid dose should be gradual, if appropriate. Clinicians should note that a reduction in corticosteroid dose may be associated with withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Immunogenicity: Dupilumab antibodies, including neutralizing antibodies, may develop; may be associated with lower serum dupilumab concentrations.
• Vaccines: Patients should be up to date with all immunizations before initiating therapy. The manufacturer’s labeling states to avoid the use of live vaccines in patients treated with dupilumab since clinical trials excluded the use of live vaccines. A systematic review and Delphi consensus suggest that vaccination, including live vaccination, can be safely administered during dupilumab therapy. Vaccine timing and response evaluation during dupilumab is limited to a small number of patients and clinical scenarios (eg, outbreak). The decision and timing of vaccination should be evaluated in a shared decision-making capacity (Lieberman 2024).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Auto-injector, Subcutaneous [preservative free]:
Dupixent: 300 mg/2 mL (2 mL); 200 mg/1.14 mL (1.14 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Dupixent: 100 mg/0.67 mL (0.67 mL [DSC]) [latex free; contains polysorbate 80]
Dupixent: 300 mg/2 mL (2 mL); 200 mg/1.14 mL (1.14 mL) [contains polysorbate 80]
No
Solution Auto-injector (Dupixent Subcutaneous)
200MG/1.14ML (per mL): $2,101.77
300 mg/2 mL (per mL): $1,198.01
Solution Prefilled Syringe (Dupixent Subcutaneous)
200MG/1.14ML (per mL): $2,101.77
300 mg/2 mL (per mL): $1,198.01
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Dupixent: 300 mg/2 mL (2 mL); 200 mg/1.14 mL (1.14 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Dupixent: 300 mg/2 mL (2 mL); 200 mg/1.14 mL (1.14 mL) [contains polysorbate 80]
SUBQ: Administer as a subcutaneous injection into the thigh or lower abdomen (avoiding areas within 2 inches of navel); caregiver may administer in upper arm. Rotate injection sites, including initial doses (administer 600 mg initial dose as two 300 mg injections at different sites; administer 400 mg initial dose as two 200 mg injections at different sites). Do not administer into skin that is tender, damaged, bruised, or scarred. Patients may self-administer injection after proper training. Allow solution to reach room temperature for 45 minutes (300 mg prefilled syringe or prefilled pen) or 30 minutes (200 mg prefilled syringe or prefilled pen; 100 mg prefilled syringe) prior to use; after removal from the refrigerator, must be used within 14 days or discarded. Do not heat prefilled pen in microwave, hot water, or direct sunlight; do not remove needle cap while allowing product to reach room temperature. Do not shake. Do not use if solution is discolored or contains particulate matter. Do not administer if window on prefilled pen is yellow (indicates pen has been used). Prefilled syringes and pens do not contain a preservative; discard unused portion. Refer to manufacturer's labeling for additional information.
Parenteral: Note: Prefilled syringe may be used in ages ≥6 months; prefilled pen is only for use in ages ≥2 years. Patients ≥12 years of age may self-administer injection under adult supervision after proper training; doses in patients <12 years of age should be administered by a properly trained caregiver.
SUBQ: Allow prefilled syringe/pen to reach room temperature for 45 minutes (300 mg prefilled syringe/pen) or 30 minutes (200 mg prefilled syringe/pen or 100 mg prefilled syringe) prior to use; do not remove needle cap while allowing product to reach room temperature; do not heat prefilled pen in microwave, hot water, or direct sunlight. Do not shake. Do not use if solution is discolored or contains particulate matter. Do not administer if window on prefilled pen is yellow (indicates pen has been used). Administer as a subcutaneous injection into the thigh or lower abdomen (avoiding areas within 2 inches of navel); caregiver may administer in patient's upper arm. Rotate injection sites, including initial doses (administer 600 mg initial dose as two 300 mg injections at different injection sites; administer 400 mg initial dose as two 200 mg injections at different injection sites). Do not rub skin after injection. Do not administer into skin that is tender, damaged, bruised, or scarred. Prefilled syringes and pens do not contain a preservative; discard unused portion.
Missed dose:
For once-weekly dosing: If a dose is missed, administer dose as soon as possible and start new weekly schedule from the date of last administered dose.
For every-other-week dosing: If a dose is missed, administer within 7 days from the missed dose and then resume the original schedule. If the missed dose is not administered within 7 days, wait until the next dose on the original schedule.
For every-4-weeks dosing: If a dose is missed, administer within 7 days from the missed dose and then resume the original schedule. If the missed dose is not administered within 7 days, a new schedule should be started based on the date next dose given.
Asthma, moderate to severe eosinophilic phenotype or oral glucocorticoid dependent: Add-on maintenance treatment of moderate to severe asthma in adults and pediatric patients ≥6 years of age with an eosinophilic phenotype or with corticosteroid dependent asthma.
Limitations of use: Not indicated for the relief of acute bronchospasm or status asthmaticus.
Atopic dermatitis, moderate to severe: Treatment of moderate to severe atopic dermatitis in adults and pediatric patients ≥6 months of age whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Chronic obstructive pulmonary disease, refractory (prevention of exacerbation): Add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease and an eosinophilic phenotype.
Limitations of use: Not indicated for the relief of acute bronchospasm.
Eosinophilic esophagitis: Treatment of adult and pediatric patients ≥1 year of age, weighing ≥15 kg, with eosinophilic esophagitis.
Prurigo nodularis: Treatment of adult patients with prurigo nodularis.
Rhinosinusitis, chronic, with nasal polyps: Add-on maintenance treatment in adults and pediatric patients ≥12 years of age with inadequately controlled chronic rhinosinusitis with nasal polyps.
Urticaria, chronic spontaneous: Treatment of chronic spontaneous urticaria in adults and pediatric patients ≥12 years of age who remain symptomatic despite H1 antihistamine treatment.
Limitations of use: Not indicated for other forms of urticaria.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Vaccines (Live): Dupilumab may increase adverse/toxic effects of Vaccines (Live). Risk X: Avoid
Outcome data following use of dupilumab in patients planning a pregnancy are limited (Bosma 2021). Consider the long half-life of monoclonal antibodies when treating patients planning to become pregnant (Pfaller 2021).
Dupilumab is a humanized monoclonal antibody (IgG4). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Outcome data following use of dupilumab in pregnant patients are limited primarily to case reports (Akuffo-Addo 2023; Avallone 2024; Escolà 2023; Hong 2024; Khamisy-Farah 2021; Metko 2024).
Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes). Maternal asthma symptoms should be monitored every 4 to 6 weeks during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2024).
Data related to the use of monoclonal antibodies for the treatment of severe asthma during pregnancy are limited (GINA 2024). Use of monoclonal antibodies may be considered when conventional therapies are insufficient (ERS/TSANZ [Middleton 2020]). In general, monoclonal antibodies should not be initiated during pregnancy. The option to continue treatment in patients who become pregnant during therapy should be considered as part of a shared decision-making process (Dorscheid 2022; Pfaller 2021).
Therapies other than dupilumab are recommended for the treatment of atopic dermatitis (Adam 2023; Deleuran 2024; Vestergaard 2019) and chronic rhinosinusitis with nasal polyps (Fokkens 2023) in pregnant patients.
Data collection to monitor pregnancy and infant outcomes following exposure to dupilumab is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (1-877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.
Dupilumab is present in breast milk.
Data related to the presence of dupilumab in breast milk are available from a lactating patient who restarted treatment for atopic dermatitis 2.5 months postpartum. Dupilumab 300 mg was given subcutaneously, and breast milk and maternal plasma were sampled 3 days later. Breast milk concentrations of dupilumab were ~1.3% of the maternal plasma (maternal plasma: 85.7 mg/L; breast milk: 1.1 mg/L) (Dekkers 2023). Outcome data following use in breastfeeding patients are limited (Alvarenga 2023; Di Lernia 2024; Kage 2020; Kage 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Use of monoclonal antibodies for the treatment of asthma in lactating patients may be considered when conventional therapies are insufficient; use of an agent other than dupilumab may be preferred (ERS/TSANZ [Middleton 2020]).
Monitor for signs/symptoms of arthralgia and psoriatic arthritis (consider rheumatological evaluation in patients with signs of arthralgia), hypersensitivity reactions, and ocular adverse effects (consider eye exam in patients with unresolved conjunctivitis); signs of infection; signs/symptoms of vasculitis or hypereosinophilia (eg, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy); blood eosinophil levels (1 month and 3 months after initiation, then periodically, or as often as every 2 to 4 weeks if eosinophils are>1,500 cells/mcL) (Fokkens 2023); signs/symptoms of psoriasis.
Asthma and chronic obstructive pulmonary disease: Exacerbations, symptom control, and lung function.
Chronic rhinosinusitis with nasal polyps: Monitor treatment response (eg, SNOT-22 test, smell tests, congestion scores, CT scan, nasal polyp score) at 6 months, 12 months, then annually (Fokkens 2023).
Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by binding to the IL-4Rα subunit. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. However, the mechanism of dupilumab action has not been definitively established; important inflammatory components of asthma, atopic dermatitis, chronic obstructive pulmonary disease, chronic sinusitis with nasal polyps, and eosinophilic esophagitis are IL-4 and IL-13.
Distribution: Vd: ~4.8 ± 1.3 L.
Metabolism: Monoclonal antibodies are primarily degraded into small peptides and amino acids by catabolism.
Bioavailability: 61% to 64%.
Time to peak: ~1 week.
Excretion: Clearance: The median time to non-detectable concentrations is 10 to 11 weeks (for 300 mg every 2 weeks), 13 weeks (for 300 mg weekly), and 9 weeks (for 200 mg every 2 weeks). In a population pharmacokinetic study, age did not affect clearance in ages ≥6 years; however, clearance is increased with age in infants ≥6 months to children ≤5 years.
Weight: Dupilumab trough concentrations were lower in subjects with higher body weight.
