dupilumab (Rx)

Brand and Other Names:Dupixent
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for injection

  • 300mg/2mL single-dose prefilled syringe

Atopic Dermatitis

Indicated for adults 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)

Also see Administration

Eosinophilic Esophagitis (Orphan)

Orphan designation for treatment of eosinophilic esophagitis

Sponsor

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

Safety and efficacy not established

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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 generalized urticaria and serum sickness or serum sicknesslike reactions, reported; if a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue dupilumab

            Conjunctivitis and keratitis were reported more frequently in the treatment group during clinical trials

            Safety and efficacy have not been established in patients with asthma; advise patients with comorbid asthma not to adjust or stop their asthma treatments without consultation with their physicians

            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

            There are no available data on use in pregnant women to inform any drug associated risk

            Human IgG antibodies are known to cross the placental barrier; therefore, dupilumab may be transmitted from the mother to the developing fetus

            Lactation

            Unknown if distributed in human breast milk

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the 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.

            more...
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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) 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

            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

            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.
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