has dupixent been used in patients under 6 months old?

1.

Food and Drug Administration (DailyMed).

Publish date: April 5, 2024.

Use In Specific Populations Of the 367 subjects, 120 were treated with Dupixent (dupilumab) 300 mg Q4W + TCS (15 to <30 kg) or 200 mg Q2W + TCS (≥30 kg) and 123 were treated with matching placebo + TCS AD-1539 which included 162 pediatric subjects 6 months to 5 years of age with moderate-to-severe AD. Of the 162 subjects, 83 were treated with Dupixent (dupilumab) 200 mg Q4W + TCS (5 to <15 kg) or 300 mg Q4W + TCS (15 to <30 kg) and 79 subjects were assigned to be treated with matching placebo + TCS AD-1434, an open-label extension study that enrolled 275 pediatric subjects 12 to 17 years of age treated with Dupixent (dupilumab) ± TCS, 368 pediatric subjects 6 to 11 years of age treated with Dupixent (dupilumab) ± TCS, and 180 pediatric subjects 6 months to 5 years of age treated with Dupixent (dupilumab) ± TCS Liberty-AD-HAFT which included 27 pediatric subjects 12 to 17 years of age with atopic dermatitis with moderate-to-severe hand and/or foot involvement treated with Dupixent (dupilumab) (N=14) or matching placebo (N=13) The safety and effectiveness were generally consistent between pediatric and adult patients [see Adverse Reactions (6.1) and Clinical Studies (14.1) ]. In addition, hand-foot-and-mouth disease was reported in 9 (5%) pediatric subjects and skin papilloma was reported in 4 (2%) pediatric subjects 6 months to 5 years of age treated with Dupixent (dupilumab) ± TCS in AD-1434. These cases did not lead to study drug discontinuation [see Adverse Reactions (6.1) ]. Safety and effectiveness in pediatric patients younger than 6 months of age with AD have not been established.

Pediatric Use Of the 162 subjects, 83 were treated with Dupixent (dupilumab) 200 mg Q4W + TCS (5 to <15 kg) or 300 mg Q4W + TCS (15 to <30 kg) and 79 subjects were assigned to be treated with matching placebo + TCS AD-1434, an open-label extension study that enrolled 275 pediatric subjects 12 to 17 years of age treated with Dupixent (dupilumab) ± TCS, 368 pediatric subjects 6 to 11 years of age treated with Dupixent (dupilumab) ± TCS, and 180 pediatric subjects 6 months to 5 years of age treated with Dupixent (dupilumab) ± TCS Liberty-AD-HAFT which included 27 pediatric subjects 12 to 17 years of age with atopic dermatitis with moderate-to-severe hand and/or foot involvement treated with Dupixent (dupilumab) (N=14) or matching placebo (N=13) The safety and effectiveness were generally consistent between pediatric and adult patients [see Adverse Reactions (6.1) and Clinical Studies (14.1) ]. In addition, hand-foot-and-mouth disease was reported in 9 (5%) pediatric subjects and skin papilloma was reported in 4 (2%) pediatric subjects 6 months to 5 years of age treated with Dupixent (dupilumab) ± TCS in AD-1434. These cases did not lead to study drug discontinuation [see Adverse Reactions (6.1) ]. Safety and effectiveness in pediatric patients younger than 6 months of age with AD have not been established. Asthma The safety and effectiveness of Dupixent (dupilumab) for an add-on maintenance treatment in patients with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma have been established in pediatric patients 6 years of age and older. Use of Dupixent (dupilumab) for this indication is supported by evidence from adequate and well-controlled studies in adult and pediatric patients 6 years and older [see Clinical Studies (14.2) ].

2.

Elsevier ClinicalKey Drug Monograph

Content last updated: April 4, 2024.

Administration * ### **General Administration Information** For storage information, see the specific product information within the How Supplied section. * ### **Route-Specific Administration** * Injectable Administration * * Administer by subcutaneous injection only. * Available in a prefilled syringe and prefilled pen for ease of patient administration. The prefilled pen is for use in adults and pediatric patients 2 years and older. The prefilled syringe is for use in adult and pediatric patients aged 6 months and older. Adults and pediatric patients 12 years and older who are properly trained in the injection technique may self-inject using the prefilled pen or prefilled syringe if the prescriber deems the action appropriate. For patients 12 to 17 years, it is recommended that the injection be given by or under the supervision of an adult. For patients 6 months to 11 years, the injection should only be given by a caregiver. The patient should not inject themselves, nor should a caregiver inject someone else, until proper training in subcutaneous injection is complete. A health care professional can show the patient or the caregiver how to prepare and inject a dose before they try to do it for the first time. * Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should be clear to slightly opalescent or colorless to pale yellow. Do not use if the solution contains visible particulate matter or is discolored or cloudy (other than acceptable coloration). * Do not use the syringe if it has been dropped on a hard surface, damaged or the needle cap is not securely attached. Do not use the pen if it has been damaged, if the cap is not securely attached, or if the window is yellow. * Missed dose: * If a weekly dose is missed, administer the dose as soon as possible. Start a new weekly schedule from the date of the last administered dose. * If an every 2 week dose is missed, administer the injection within 7 days from the missed dose. Resume original schedule. If the missed dose is not administered within 7 days, wait for the next scheduled dose.

Description Dupixent, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass. Dupixent is used subcutaneously and this biologic agent has utility in diseases such as asthma, eczema, eosinophilic esophagitis, nasal polyps due to chronic sinusitis, and prurigo nodularis. Dupixent is indicated for the treatment of adult and pediatric patients 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable; dupixent may be used with or without topical corticosteroids. Dupixent is also indicated for the treatment of eosinophilic esophagitis in adult and pediatric patients 1 year and older, weighing at least 15 kg. In adults only, the drug is approved for use as an add-on maintenance treatment in patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP) and for the treatment of prurigo nodularis. Dupixent is indicated as add-on asthma maintenance therapy for moderate-to-severe asthma in patients 6 years and older with an eosinophilic phenotype or for moderate-to-severe oral corticosteroid (OCS)-dependent asthma. The NAEPP includes add-on dupixent therapy as a consideration in adult and pediatric patients 12 years and older with severe persistent asthma after confirmatory phenotyping. However, the NAEPP has withheld specific recommendations for the use of newer biologics for patients with severe asthma (NAEPP steps 5 and 6) pending further clinical study assessments of the role of biologics in patients with specific phenotypes and/or endotypes.

Indications And Dosage **For the treatment of moderate to severe atopic dermatitis (eczema) in persons whose disease is not adequately controlled with topical therapies or when use of those therapies is not advisable** NOTE: Dupixent can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. Subcutaneous dosage Adults: 600 mg subcutaneously once, followed by 300 mg subcutaneously every other week. Children and Adolescents 6 to 17 years weighing 60 kg or more: 600 mg subcutaneously once, followed by 300 mg subcutaneously every other week. Children and Adolescents 6 to 17 years weighing 30 to 59 kg: 400 mg subcutaneously once, followed by 200 mg subcutaneously every other week. Children and Adolescents 6 to 17 years weighing 15 to 29 kg: 600 mg subcutaneously once, followed by 300 mg subcutaneously every 4 weeks. Infants and Children 6 months to 5 years weighing 15 to 29 kg: 300 mg subcutaneously every 4 weeks. Infants and Children 6 months to 5 years weighing 5 to 14 kg: 200 mg subcutaneously every 4 weeks.

Indications And Dosage weighing 30 to 39 kg: 400 mg subcutaneously initially, then 200 mg subcutaneously every other week for atopic dermatitis or asthma and co-morbid atopic dermatitis; 200 mg subcutaneously every other week for asthma, 300 mg subcutaneously every other week for eosinophilic esophagitis. weighing 15 to 29 kg: 600 mg subcutaneously initially, then 300 mg subcutaneously every 4 weeks for atopic dermatitis or asthma and co-morbid atopic dermatitis; 300 mg subcutaneously every 4 weeks for asthma; 200 mg subcutaneously every other week for eosinophilic esophagitis. 1 to 5 years: weighing 15 to 29 kg: 300 mg subcutaneously every 4 weeks for atopic dermatitis, 200 mg subcutaneously every other week for eosinophilic esophagitis. weighing 5 to 14 kg: 200 mg subcutaneously every 4 weeks for atopic dermatitis. • Infants 6 to 11 months: weighing 15 to 29 kg: 300 mg subcutaneously every 4 weeks for atopic dermatitis. weighing 5 to 14 kg: 200 mg subcutaneously every 4 weeks for atopic dermatitis. 1 to 5 months: Safety and efficacy have not been established. • Neonates Safety and efficacy have not been established.