dupilumab (Rx)

Brand and Other Names:Dupixent
  • Print

Dosing & Uses

AdultPediatric

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

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

Orphan Designations

Eosinophilic esophagitis

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 moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies not advisable

<6 years: Safety and efficacy not established

≥6 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

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

Next:

Interactions

Interaction Checker

and dupilumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (10)

              • 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.

              • 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.

              • 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.

              • 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.

              • 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.

              • 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 (16)

              • 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.

              • warfarin

                dupilumab, warfarin. 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)

                Previous
                Next:

                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%)

                <1%

                Keratitis

                Hypersensitivity reactions

                Eczema herpeticum

                Herpes zoster

                Previous
                Next:

                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
                Previous
                Next:

                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.

                Previous
                Next:

                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

                Previous
                Next:

                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 ≥12 years; in adolescents 12 years of age and older, adult supervision is recommended

                Prefilled syringe: Use in children aged 6-11 years: given by a caregiver

                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

                Missed dose within 7 days: Administer dose and resume the original schedule

                Missed dose >7 days
                • Every other-week dose: Wait until the next scheduled dose
                • Every 4-weeks dose: 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

                Previous
                Next:

                Images

                No images available for this drug.
                Previous
                Next:

                Patient Handout

                A Patient Handout is not currently available for this monograph.
                Previous
                Next:

                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                Additional Offers
                Email to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Email Forms to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Previous
                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.