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Dupixent

Generic Name: Dupilumab
Class: Skin and Mucous Membrane Agents, Miscellaneous

Introduction

Dupilumab, an interleukin-4 receptor alpha (IL-4Rα) antagonist, is a skin or mucous membrane agent.1

Uses for Dupixent

Dupilumab has the following uses:

Dupilumab is an interleukin-4 receptor alpha antagonist indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab can be used with or without topical corticosteroids.1

Dupixent Dosage and Administration

General

Dupilumab is available in the following dosage form(s) and strength(s):

  • Injection: 300 mg/2 mL solution in a single-dose pre-filled syringe with needle shield.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

  • Administer by subcutaneous injection.1

  • The recommended dose is an initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week.1

Cautions for Dupixent

Contraindications

Known hypersensitivity to dupilumab or any of its excipients.1

Warnings/Precautions

Hypersensitivity

Hypersensitivity reactions, including generalized urticaria and serum sickness or serum sickness-like reactions, were reported in less than 1% of subjects who received dupilumab in clinical trials. Two subjects experienced serum sickness or serum sickness-like reactions that were associated with high titers of antibodies to dupilumab. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue dupilumab.1

Conjunctivitis and Keratitis

Conjunctivitis and keratitis occurred more frequently in subjects who received dupilumab. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis recovered or were recovering during the treatment period.1

Keratitis was reported in <1% of the dupilumab group (1 per 100 subject-years) and in 0% of the placebo group (0 per 100 subject-years) in the 16-week monotherapy trials. In the 52-week dupilumab + topical corticosteroids (TCS) trial, keratitis was reported in 4% of the dupilumab + TCS group (12 per 100 subject-years) and in 0% of the placebo + TCS group (0 per 100 subject-years). Most subjects with keratitis recovered or were recovering during the treatment period.1

Advise patients to report new onset or worsening eye symptoms to their healthcare provider.1

Comorbid Asthma

Safety and efficacy of dupilumab have not been established in the treatment of asthma. Advise patients with comorbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.1

Parasitic (Helminth) Infections

Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if dupilumab will influence the immune response against helminth infections.1

Specific Populations

Pregnancy

There are no available data on dupilumab 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. In an enhanced pre- and post-natal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after subcutaneous administration of a homologous antibody against interleukin-4-receptor alpha (IL-4Rα) during organogenesis through parturition at doses up to 10-times the maximum recommended human dose (MRHD). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.1

In an enhanced pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of homologous antibody against IL-4Rα up to 10 times the MRHD (on a mg/kg basis of 100 mg/kg/week) from the beginning of organogenesis to parturition. No treatment-related adverse effects on embryofetal toxicity or malformations, or on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age.1

Lactation

There are no data on the presence of dupilumab in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. The effects of local gastrointestinal and limited systemic exposure to dupilumab on the breastfed infant are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dupilumab and any potential adverse effects on the breastfed child from dupilumab or from the underlying maternal condition.1

Pediatric Use

Safety and efficacy in pediatric patients (<18 years of age) have not been established.1

Geriatric Use

Of the 1472 subjects with atopic dermatitis exposed to dupilumab in a dose-ranging study and placebo-controlled trials, 67 subjects were 65 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects.1

Common Adverse Effects

Most common adverse reactions (incidence ≥1%) are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Live Vaccines: Avoid use of live vaccines with dupilumab.1

Actions

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. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines, and IgE.1

Advice to Patients

Advise the patients and/or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use) before the patient starts using dupilumab and each time the prescription is renewed as there may be new information they need to know.1

Administration Instructions

Provide proper training to patients and/or caregivers on proper subcutaneous injection technique, including aseptic technique, and the preparation and administration of dupilumab prior to use. Advise patients to follow sharps disposal recommendations.1

Hypersensitivity

Advise patients to discontinue dupilumab and to seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions.1

Conjunctivitis and Keratitis

Advise patients to consult their healthcare provider if new onset or worsening eye symptoms develop.1

Comorbid Asthma

Advise patients with comorbid asthma not to adjust or stop their asthma treatment without talking to their physicians.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Dupilumab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, Solution

300 mg /2 mL

Dupixent

Sanofi-Aventis U.S. LLC

AHFS Drug Information. © Copyright 2017, Selected Revisions April 7, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Sanofi-Aventis U.S. LLC. Dupixent (Dupilumab) SUBCUTANEOUS prescribing information. March 2017.

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