dupilumab (Rx)

Brand and Other Names:Dupixent
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for injections

  • 300mg/2mL
  • 200mg/1.14mL
  • Available as single-dose prefilled syringe

Atopic Dermatitis

Indicated for patients aged ≥12 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are 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

Topical calcineurin inhibitors may be used, but should be reserved for problem areas only (eg, face, neck, intertriginous, and genital areas)

Asthma

Indicated as an add-on maintenance treatment for moderate-to-severe asthma in patients aged ≥12 years 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

For patients with PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis (for which dupilumab is indicated), administer 600 mg initial dose then 300 mg q2weeks

Dosing Considerations

Not indicated for acute bronchospasm or status asthmaticus

Eosinophilic Esophagitis (Orphan)

Orphan designation for treatment of eosinophilic esophagitis

Sponsor

  • Regneron Pharmaceuticals, Inc; 777 Old Saw Mill River Road; Tarrytown, New York 10591

Dosage Forms & Strengths

solution for injection

  • 300mg/2mL
  • 200mg/1.14mL
  • Available as single-dose prefilled syringe

Atopic Dermatitis

Indicated for moderate-to-severe atopic dermatitis in adolescents aged ≥12 yr whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable; may be used with or without topical corticosteroids

<12 years: Safety and efficacy not established

≥12 years

  • ≥60 kg: 600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC every other week
  • <60 kg: 400 mg (ie, two 200-mg injections) SC once, and then 200 mg SC every other week
  • Topical calcineurin inhibitors may be used, but should be reserved for problem areas only (eg, face, neck, intertriginous, and genital areas)

Asthma

Indicated as an add-on maintenance treatment for moderate-to-severe asthma in patients aged ≥12 years with eosinophilic phenotype or PO corticosteroid dependent asthma

<12 years: Safety and efficacy not established

≥12 years

  • 400 mg SC once, then 200 mg q2weeks, OR
  • 600 mg SC once, then 300 mg q2weeks
  • For patients with PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis (for which dupilumab is indicated), administer 600 mg initial dose then 300 mg q2weeks

Dosing Considerations

Not indicated for acute bronchospasm or status asthmaticus

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Interactions

Interaction Checker

and dupilumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            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%)

            <1%

            Eosinophilia

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            Warnings

            Contraindications

            Known hypersensitivity to dupilumab or its excipients

            Cautions

            Hypersensitivity reactions, including anaphylaxis, generalized urticaria and serum sickness or serum sicknesslike 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; 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; monitor for rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy in patients with eosinophilia; physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia; cases of eosinophilic pneumonia and cases of vasculitis consistent with eosinophilic granulomatosis with polyangiitis reported

            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 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 antihelminths, 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
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            Pregnancy

            Pregnancy

            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.

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            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

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            Administration

            SC Preparation

            Remove syringe from the refrigerator and allow to reach room temperature (45 min for 300-mg syringe or 30 min for 200-mg syringe) without removing the needle cap

            Inspect visually for particulate matter and discoloration prior to administration

            Dupilumab is a clear to slightly opalescent, colorless-to-pale yellow solution; do not use if the liquid contains visible particulate matter, is discolored, or is cloudy (other than clear to slightly opalescent, colorless-to-pale yellow)

            Does not contain preservatives; therefore, discard any unused product that remains in the syringe

            SC Administration

            For SC injection only

            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 initial dose (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

            Missed dose

            • ≤7 days: Instruct patient to administer the injection within 7 days from the missed dose and then resume the original schedule
            • >7 days: Instruct patient to wait until the next scheduled dose

            Storage

            Store refrigerated at 36-46°F (2-8°C) in the original carton to protect from light

            If necessary, prefilled syringes may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days

            Do not store above 77°F (25°C)

            After removal from the refrigerator, must be used within 14 days or discard

            Do not expose the syringe to heat or direct sunlight

            Do not freeze, expose to heat, or shake

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            Images

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            Formulary

            FormularyPatient Discounts

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