Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 300mg/2mL (single-dose prefilled syringe or pen)
- 200mg/1.14mL (single-dose prefilled syringe or pen)
Atopic Dermatitis
Indicated for moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies not advisable
600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC every other week
Can be used with or without topical corticosteroids
Moderate-to-Severe Asthma
Indicated as add-on maintenance treatment for patients with eosinophilic phenotype or PO corticosteroid dependent asthma
400 mg SC once, then 200 mg q2weeks, OR
600 mg SC once, then 300 mg q2weeks
600 mg initial, then 300 mg q2weeks for patients with PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis (for which dupilumab is indicated)
Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Indicated as add-on maintenance treatment
300 mg SC q2Weeks
Eosinophilic Esophagitis
Indicated for eosinophilic esophagitis
300 mg SC qWeek
Prurigo Nodularis
Indicated for treatment of prurigo nodularis (PN)
600 mg SC once, followed by 300 mg q2Weeks
Dosing Considerations
Topical calcineurin inhibitors may be used, for topical dermatitis, but should be reserved for problem areas only (eg, face, neck, intertriginous, and genital areas)
Not indicated for acute bronchospasm or status asthmaticus
Vaccinations
- Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines before initiating treatment
Orphan Designations
Bullous pemphigoid
Orphan sponsor
- Regneron Pharmaceuticals, Inc; 777 Old Saw Mill River Road; Tarrytown, New York 10591
Dosage Forms & Strengths
injectable solution
- 300mg/2mL (single-dose prefilled syringe or pen)
- 200mg/1.14mL (single-dose prefilled syringe or pen)
- 100mg/0.67mL (single-dose prefilled syringe)
Atopic Dermatitis
Indicated for children aged ≥6 months with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies not advisable
<6 months: Safety and efficacy not established
6 months through 5 years
- No initial loading dose recommended
- 5 to <15 kg: 200 mg SC q4weeks
- 15 to <30 kg: 300 mg SC q4weeks
6-17 years
- ≥60 kg: 600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC every other week
- 30 kg to <60 kg: 400 mg (ie, two 200-mg injections) SC once, and then 200 mg SC every other week
- 15 kg to <30 kg: 600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC q4weeks
- May be used with or without topical corticosteroids
Moderate-to-Severe Asthma
Indicated as add-on maintenance treatment for patients aged ≥6 years with eosinophilic phenotype or PO corticosteroid dependent asthma
<6 years: Safety and efficacy not established
6-11 years
- No initial loading dose recommended
- 15 to <30 kg: 100 mg SC q2Weeks OR 300 mg SC q4Weeks
- ≥30 kg: 200 mg SC q2Weeks
- Patients with asthma and comorbid moderate-to-severe atopic dermatitis, follow the recommended dosage for atopic dermatitis, including initial loading dose
≥12 years
- 400 mg SC once, then 200 mg q2weeks, OR
- 600 mg SC once, then 300 mg q2weeks
- Patients with PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis: 600 mg SC once, then 300 mg q2weeks
Eosinophilic Esophagitis
Indicated for eosinophilic esophagitis in adolescents aged ≥12 years who weigh at least 40 kg
<12 years: Safety and efficacy not established
≥12 years and ≥40 kg: 300 mg SC qWeek
Dosing Considerations
Topical calcineurin inhibitors may be used, for topical dermatitis, but should be reserved for problem areas only (eg, face, neck, intertriginous, and genital areas)
Not indicated for acute bronchospasm or status asthmaticus
NOTE: Prefilled pen is only for use in adolescents aged ≥12 years
Vaccinations
- Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines before initiating treatment
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (16)
- adenovirus types 4 and 7 live, oral
dupilumab, adenovirus types 4 and 7 live, oral. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- axicabtagene ciloleucel
dupilumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
dupilumab, BCG vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- brexucabtagene autoleucel
dupilumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cholera vaccine
dupilumab, cholera vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- ciltacabtagene autoleucel
dupilumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
dupilumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, intranasal
dupilumab, influenza virus vaccine quadrivalent, intranasal. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- lisocabtagene maraleucel
dupilumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles mumps and rubella vaccine, live
dupilumab, measles mumps and rubella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- smallpox (vaccinia) vaccine, live
dupilumab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- tisagenlecleucel
dupilumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- typhoid polysaccharide vaccine
dupilumab, typhoid polysaccharide vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- typhoid vaccine live
dupilumab, typhoid vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- yellow fever vaccine
dupilumab, yellow fever vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- zoster vaccine live
dupilumab, zoster vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
Monitor Closely (15)
- carbamazepine
dupilumab, carbamazepine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- clonidine
dupilumab, clonidine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- cyclosporine
dupilumab, cyclosporine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- dengue vaccine
dupilumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- disopyramide
dupilumab, disopyramide. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- fosphenytoin
dupilumab, fosphenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- phenobarbital
dupilumab, phenobarbital. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- phenytoin
dupilumab, phenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- primidone
dupilumab, primidone. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- quinidine
dupilumab, quinidine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- quinine
dupilumab, quinine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- sirolimus
dupilumab, sirolimus. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- tacrolimus
dupilumab, tacrolimus. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- theophylline
dupilumab, theophylline. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- valproic acid
dupilumab, valproic acid. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
Minor (0)
Adverse Effects
>10%
Asthma
- Injection site reactions (14-18%)
1-10%
Atopic dermatitis
- Injection site reactions (10%)
- Conjunctivitis (9-10%)
- Blepharitis (<1-5%)
- Oral herpes (3-4%)
- Keratitis (<1-4%)
- Immunogenicity, neutralizing (2%)
- Eye pruritus (1-2%)
- Other herpes simplex virus infection (1-2%)
- Dry eye (<1-2%)
Asthma (adults)
- Oropharyngeal pain (2%)
- Eosinophilia (2%)
Asthma (6-11 years)
- Helminth infections (2.2%)
CRSwNP
- Infection site reaction (6%)
- Arthralgia (3%)
- Conjunctivitis (2%)
- Gastritis (2%)
- Insomnia (1%)
- Eosinophilia (1%)
- Toothache (1%)
PN
- Nasopharyngitis (5%)
- Conjunctivitis (4%)
- Herpes infections (3%)
- Dizziness (3%)
- Myalgia (3%)
- Diarrhea (3%)
<1%
Keratitis
Hypersensitivity reactions
Eczema herpeticum
Herpes zoster
Postmarketing Reports
Immune system disorders: angioedema
Skin and subcutaneous tissue disorders: Facial skin reactions, including erythema, rash, scaling, edema, papules, pruritus, burning, and pain
Chronic rhinosinusitis with nasal polyposis
Eosinophilic esophagitis
Prurigo nodularis
Warnings
Contraindications
Known hypersensitivity to dupilumab or its excipients
Cautions
Hypersensitivity reactions, including anaphylaxis, generalized urticaria, rash, erythema nodosum, and serum sickness or serum sickness-like reactions, reported; if clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue dupilumab
Conjunctivitis and keratitis reported more frequently in the treatment group during clinical trials for atopic dermatitis and CRSwNP; however, when treating asthma, incidence was similar to placebo
Patients with asthma may present with serious systemic eosinophilia, including clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis; these events may be associated with reduction of PO corticosteroids; monitor for rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy in patients with eosinophilia
Do not use to treat acute bronchospasm or status asthmaticus
Do not abruptly discontinue corticosteroid therapy upon initiation; reduce corticosteroid doses gradually, if appropriate, under physician supervision
Instruct patients with atopic dermatitis or CRSwNP who have comorbid asthma not to adjust or stop their asthma therapy without consulting their physician
Patients with pre-existing helminth infections were excluded from clinical trials; treat infections before initiating; if patient becomes infected and is unresponsive to anthelmintics, discontinue dupilumab until infection resolves
Drug interaction overview
- Avoid coadministration with live vaccines
-
CYP450 substrates
- The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, interleukin [IL]-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation
- Dupilumab may modulate serum levels of some cytokines
- Therefore, upon initiating or discontinuing dupilumab in patients who are receiving concomitant drugs that are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, for cyclosporine) and consider dosage modification of the CYP450 substrate
Pregnancy
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy
Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or to obtain information about the registry
Available data from case reports and case series on use in pregnant women have not identified drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; human IgG antibodies are known to cross the placental barrier; therefore, drug may be transmitted from mother to developing fetus; there are adverse effects on maternal and fetal outcomes associated with asthma in pregnancy
In women with poorly or moderately controlled asthma, evidence demonstrates there is an increased risk of preeclampsia in mother and prematurity, low birth weight, and small for gestational age in the neonate; level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control
Lactation
There are no data on presence of dupilumab in human milk, effects on breastfed infant, or on milk production; maternal IgG is known to be present in human milk; effects of local gastrointestinal exposure and limited systemic exposure to dupilumab on breastfed infant are unknown; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Monoclonal antibody that inhibits interleukin-4 (IL-4) and IL-13 signaling by specifically binding to the IL-4R-alpha subunit shared by the IL-4 and IL-13 receptor complexes
Blocking the IL-4R-alpha subunit inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines, and IgE
Absorption
Bioavailability: 64%
Peak plasma time: ~1 week
Peak plasma concentration: 70.1 mcg/mL
Distribution
Vd: 4.8 L
Metabolism
Metabolic pathway has not been characterized
Administration
SC Preparation
Remove drug from refrigerator and allow to reach room temperature (45 min for 300-mg prefilled syringe/pen or 30 min for 200-mg prefilled syringe/pen and 100-mg prefilled syringe) without removing needle cap
Inspect visually for particulate matter and discoloration before administration; solution is clear to slightly opalescent, colorless-to-pale yellow; discard if liquid appears discolored, cloudy, or contains visible particulate matter
Does not contain preservatives; discard any remaining drug
SC Administration
For SC injection only
Prefilled pen: Use only in adults and adolescents aged ≥2 years; ≥12 years patient may administer injection and parental supervision is recommended for patients aged 12-17 yr
Prefilled syringe: Use in children aged ≥6 months; caregivers should administer injection in patients aged 6 months to <12 years
May self-administer SC into the thigh or abdomen, except for the 2 inches around the navel
May inject in the upper arm if administered by a caregiver
For atopic dermatitis and asthma initial doses (ie, two 300-mg or two 200-mg injection), administer each injection at different injection sites
Rotate injection site with each injection
Do not inject into skin that is tender, damaged, bruised, or scarred
Provide proper training to patients and/or caregivers on preparation and administration
Missed dose
- Weekly dose missed: Administer dose as soon as possible; start a new weekly schedule from date of last administered dose
-
Every other week-dose missed
- Missed dose within 7 days: Administer dose and resume the original schedule
- Missed dose >7 days: Wait until the next scheduled dose
-
Every 4-weeks dose missed
- Administer missed dose within 7 days: Resume the original schedule
- Administer missed dose >7 days: Start a new schedule based on the missed dose date
Storage
Refrigerate at 36-46ºF (2-8ºC) in the original carton to protect from light
If necessary, prefilled syringes or pens may be kept at room temperature up to 77°F (25°C) for up to 14 days; do not store above 77°F (25°C)
After removal from the refrigerator, discard after 14 days
Protect from heat or direct sunlight
Do not freeze, expose to heat, or shake
Images
Formulary
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