Dupixent

— THERAPEUTIC CATEGORIES —
  • Asthma/COPD
  • Atopic dermatitis
  • Miscellaneous gastrohepatic disorders
  • Miscellaneous respiratory disorders
  • Pruritus and dry skin
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Dupixent Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Dupilumab 200mg/1.14mL, 300mg/2mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-4 receptor alpha antagonist.

    How Supplied

    Single-dose prefilled syringes—2 (w. needle shield); Single-dose prefilled pens—2

    Manufacturer

    Sanofi US and Regeneron

    Generic Availability

    NO

    Mechanism of Action

    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. By blocking IL-4Rα, dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The mechanism of action of dupilumab in asthma, however, has not been definitively established.

    Dupixent Indications

    Indications

    As an add-on maintenance treatment in patients with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma.

    Limitations of Use

    Not for relief of acute bronchospasm or status asthmaticus.

    Dupixent Dosage and Administration

    Adult

    Give by SC inj into thigh, abdomen (except around navel), or upper arm; rotate inj sites. ≥12yrs: Initially 400mg (two 200mg inj at different sites) followed by 200mg every 2 weeks; or, initially 600mg (two 300mg inj at different sites) followed by 300mg every 2 weeks. For those with oral corticosteroid-dependent asthma or with co-morbid moderate to severe atopic dermatitis or co-morbid chronic rhinosinusitis with nasal polyposis: initially 600mg (two 300mg inj at different sites) followed by 300mg every 2 weeks.

    Children

    <6yrs: not established. Can use prefilled pens for patients ≥2yrs. Initial loading dose is not recommended for patients 6–11yrs. Give by SC inj into thigh, abdomen (except around navel), or upper arm; rotate inj sites. 6–11yrs (15–<30kg): 300mg every 4 weeks; (≥30kg): 200mg every other week. For those with asthma and co-morbid moderate to severe atopic dermatitis: follow dosage for atopic dermatitis which includes an initial loading dose.

    Dupixent Contraindications

    Not Applicable

    Dupixent Boxed Warnings

    Not Applicable

    Dupixent Warnings/Precautions

    Warnings/Precautions

    Discontinue if significant hypersensitivity reaction occurs; treat appropriately. New onset or worsening eye or joint symptoms; seek specialists if persist or worsen. Avoid abrupt discontinuation of any corticosteroids upon Dupixent initiation. Atopic dermatitis or CRSwNP patients with co-morbid asthma. Treat pre-existing helminth infections prior to initiation; if infection develops and unresponsive to anthelmintics, discontinue Dupixent until resolves. Do not inject into tender, damaged, bruised or scarred skin. Update all vaccinations according to current guidelines prior to initiation. Pregnancy. Nursing mothers.

    Dupixent Pharmacokinetics

    Distribution

    Volume of distribution: ~4.8 ± 1.3 L.

    Metabolism

    Catabolic pathways.

    Dupixent Interactions

    Interactions

    Avoid concomitant live vaccines.

    Dupixent Adverse Reactions

    Adverse Reactions

    Inj site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, oropharyngeal pain, eosinophilia, insomnia, toothache, gastritis, arthralgia, nasopharyngitis, dizziness, myalgia, diarrhea, upper respiratory tract infections; hypersensitivity.

    Dupixent Clinical Trials

    See Literature

    Dupixent Note

    Not Applicable

    Dupixent Patient Counseling

    See Literature

    Dupixent Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Dupilumab 200mg/1.14mL, 300mg/2mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-4 receptor alpha antagonist.

    How Supplied

    Single-dose prefilled syringes—2 (w. needle shield); Single-dose prefilled pens—2

    Manufacturer

    Sanofi US and Regeneron

    Generic Availability

    NO

    Mechanism of Action

    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. By blocking IL-4Rα, dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The mechanism of action of dupilumab in asthma, however, has not been definitively established.

    Dupixent Indications

    Indications

    Moderate to severe atopic dermatitis in patients who are not adequately controlled with topical prescription therapies or when they are not advisable.

    Dupixent Dosage and Administration

    Adults and Children

    <6 months: not established. Can use prefilled pens for patients ≥2yrs. Give by SC inj into thigh, abdomen (except around navel), or upper arm; rotate inj sites. 6mos–5yrs (5–<15kg): 200mg every 4 weeks; (15–<30kg): 300mg every 4 weeks. 6–17yrs (15–<30kg): initially 600mg (two 300mg inj at different sites) followed by 300mg every 4 weeks; (30–<60kg): initially 400mg (two 200mg inj at different sites) followed by 200mg every other week; (≥60kg): initially 600mg (two 300mg inj at different sites) followed by 300mg every other week. ≥18yrs: initially 600mg (two 300mg inj at different sites) followed by 300mg every other week. May use with or without topical corticosteroids. Topical calcineurin inhibitors may also be used, but should be reserved only for problem areas (eg, face, neck, intertriginous and genital areas).

    Dupixent Contraindications

    Not Applicable

    Dupixent Boxed Warnings

    Not Applicable

    Dupixent Warnings/Precautions

    Warnings/Precautions

    Discontinue if significant hypersensitivity reaction occurs; treat appropriately. New onset or worsening eye or joint symptoms; seek specialists if persist or worsen. Avoid abrupt discontinuation of any corticosteroids upon Dupixent initiation. Atopic dermatitis or CRSwNP patients with co-morbid asthma. Treat pre-existing helminth infections prior to initiation; if infection develops and unresponsive to anthelmintics, discontinue Dupixent until resolves. Do not inject into tender, damaged, bruised or scarred skin. Update all vaccinations according to current guidelines prior to initiation. Pregnancy. Nursing mothers.

    Dupixent Pharmacokinetics

    Distribution

    Volume of distribution: ~4.8 ± 1.3 L.

    Metabolism

    Catabolic pathways.

    Dupixent Interactions

    Interactions

    Avoid concomitant live vaccines.

    Dupixent Adverse Reactions

    Adverse Reactions

    Inj site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, oropharyngeal pain, eosinophilia, insomnia, toothache, gastritis, arthralgia, nasopharyngitis, dizziness, myalgia, diarrhea, upper respiratory tract infections; hypersensitivity.

    Dupixent Clinical Trials

    See Literature

    Dupixent Note

    Not Applicable

    Dupixent Patient Counseling

    See Literature

    Dupixent Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Dupilumab 200mg/1.14mL, 300mg/2mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-4 receptor alpha antagonist.

    How Supplied

    Single-dose prefilled syringes—2 (w. needle shield); Single-dose prefilled pens—2

    Manufacturer

    Sanofi US and Regeneron

    Generic Availability

    NO

    Mechanism of Action

    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. By blocking IL-4Rα, dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The mechanism of action of dupilumab in asthma, however, has not been definitively established.

    Dupixent Indications

    Indications

    Eosinophilic esophagitis.

    Dupixent Dosage and Administration

    Adults and Children

    <1yr: not established. Give by SC inj into thigh, abdomen (except around navel), or upper arm; rotate inj sites. 1yr: (15–<30kg): 200mg every other week; (30–<40kg): 300mg every other week; (≥40kg): 300mg every week.

    Dupixent Contraindications

    Not Applicable

    Dupixent Boxed Warnings

    Not Applicable

    Dupixent Warnings/Precautions

    Warnings/Precautions

    Discontinue if significant hypersensitivity reaction occurs; treat appropriately. New onset or worsening eye or joint symptoms; seek specialists if persist or worsen. Avoid abrupt discontinuation of any corticosteroids upon Dupixent initiation. Atopic dermatitis or CRSwNP patients with co-morbid asthma. Treat pre-existing helminth infections prior to initiation; if infection develops and unresponsive to anthelmintics, discontinue Dupixent until resolves. Do not inject into tender, damaged, bruised or scarred skin. Update all vaccinations according to current guidelines prior to initiation. Pregnancy. Nursing mothers.

    Dupixent Pharmacokinetics

    Distribution

    Volume of distribution: ~4.8 ± 1.3 L.

    Metabolism

    Catabolic pathways.

    Dupixent Interactions

    Interactions

    Avoid concomitant live vaccines.

    Dupixent Adverse Reactions

    Adverse Reactions

    Inj site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, oropharyngeal pain, eosinophilia, insomnia, toothache, gastritis, arthralgia, nasopharyngitis, dizziness, myalgia, diarrhea, upper respiratory tract infections; hypersensitivity.

    Dupixent Clinical Trials

    See Literature

    Dupixent Note

    Not Applicable

    Dupixent Patient Counseling

    See Literature

    Dupixent Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Dupilumab 200mg/1.14mL, 300mg/2mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-4 receptor alpha antagonist.

    How Supplied

    Single-dose prefilled syringes—2 (w. needle shield); Single-dose prefilled pens—2

    Manufacturer

    Sanofi US and Regeneron

    Generic Availability

    NO

    Mechanism of Action

    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. By blocking IL-4Rα, dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The mechanism of action of dupilumab in asthma, however, has not been definitively established.

    Dupixent Indications

    Indications

    As an add-on maintenance treatment in patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

    Dupixent Dosage and Administration

    Adult

    Give by SC inj into thigh, abdomen (except around navel), or upper arm; rotate inj sites. ≥18yrs: 300mg every other week.

    Children

    <18yrs: not established.

    Dupixent Contraindications

    Not Applicable

    Dupixent Boxed Warnings

    Not Applicable

    Dupixent Warnings/Precautions

    Warnings/Precautions

    Discontinue if significant hypersensitivity reaction occurs; treat appropriately. New onset or worsening eye or joint symptoms; seek specialists if persist or worsen. Avoid abrupt discontinuation of any corticosteroids upon Dupixent initiation. Atopic dermatitis or CRSwNP patients with co-morbid asthma. Treat pre-existing helminth infections prior to initiation; if infection develops and unresponsive to anthelmintics, discontinue Dupixent until resolves. Do not inject into tender, damaged, bruised or scarred skin. Update all vaccinations according to current guidelines prior to initiation. Pregnancy. Nursing mothers.

    Dupixent Pharmacokinetics

    Distribution

    Volume of distribution: ~4.8 ± 1.3 L.

    Metabolism

    Catabolic pathways.

    Dupixent Interactions

    Interactions

    Avoid concomitant live vaccines.

    Dupixent Adverse Reactions

    Adverse Reactions

    Inj site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, oropharyngeal pain, eosinophilia, insomnia, toothache, gastritis, arthralgia, nasopharyngitis, dizziness, myalgia, diarrhea, upper respiratory tract infections; hypersensitivity.

    Dupixent Clinical Trials

    See Literature

    Dupixent Note

    Not Applicable

    Dupixent Patient Counseling

    See Literature

    Dupixent Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Dupilumab 200mg/1.14mL, 300mg/2mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-4 receptor alpha antagonist.

    How Supplied

    Single-dose prefilled syringes—2 (w. needle shield); Single-dose prefilled pens—2

    Manufacturer

    Sanofi US and Regeneron

    Generic Availability

    NO

    Mechanism of Action

    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. By blocking IL-4Rα, dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The mechanism of action of dupilumab in asthma, however, has not been definitively established.

    Dupixent Indications

    Indications

    Prurigo nodularis.

    Dupixent Dosage and Administration

    Adult

    Give by SC inj into thigh, abdomen (except around navel), or upper arm; rotate inj sites. ≥18yrs: initially 600mg (two 300mg inj at different sites) followed by 300mg every other week.

    Children

    <18yrs: not established.

    Dupixent Contraindications

    Not Applicable

    Dupixent Boxed Warnings

    Not Applicable

    Dupixent Warnings/Precautions

    Warnings/Precautions

    Discontinue if significant hypersensitivity reaction occurs; treat appropriately. New onset or worsening eye or joint symptoms; seek specialists if persist or worsen. Avoid abrupt discontinuation of any corticosteroids upon Dupixent initiation. Atopic dermatitis or CRSwNP patients with co-morbid asthma. Treat pre-existing helminth infections prior to initiation; if infection develops and unresponsive to anthelmintics, discontinue Dupixent until resolves. Do not inject into tender, damaged, bruised or scarred skin. Update all vaccinations according to current guidelines prior to initiation. Pregnancy. Nursing mothers.

    Dupixent Pharmacokinetics

    Distribution

    Volume of distribution: ~4.8 ± 1.3 L.

    Metabolism

    Catabolic pathways.

    Dupixent Interactions

    Interactions

    Avoid concomitant live vaccines.

    Dupixent Adverse Reactions

    Adverse Reactions

    Inj site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, oropharyngeal pain, eosinophilia, insomnia, toothache, gastritis, arthralgia, nasopharyngitis, dizziness, myalgia, diarrhea, upper respiratory tract infections; hypersensitivity.

    Dupixent Clinical Trials

    See Literature

    Dupixent Note

    Not Applicable

    Dupixent Patient Counseling

    See Literature

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