Dupixent

Treatment of moderate to severe atopic dermatitis in adults & adolescents ≥12 yr who are candidates for systemic therapy; severe atopic dermatitis in childn 6 mth to 11 yr who are candidates for systemic therapy. Add-on maintenance treatment for severe asthma w/ type 2 inflammation characterised by raised blood eosinophils &/or raised fraction of exhaled nitric oxide (FeNO) in adults & adolescents ≥12 yr who are inadequately controlled w/ high-dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. 300 mg: Add-on maintenance treatment for severe asthma w/ type 2 inflammation characterised by raised blood eosinophils &/or raised FeNO in childn 6-11 yr who are inadequately controlled w/ medium- to high-dose ICS plus another medicinal product for maintenance treatment. Add-on therapy w/ intranasal corticosteroids for the treatment of severe chronic rhinosinusitis w/ nasal polyposis (CRSwNP) in adults for whom therapy w/ systemic corticosteroids &/or surgery do not provide adequate disease control. Treatment of moderate to severe prurigo nodularis in adults who are candidates for systemic therapy. Treatment of eosinophilic esophagitis in adults & adolescents ≥12 yr, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. Add-on maintenance treatment for uncontrolled COPD in adults characterised by raised blood eosinophils on a combination of ICS, long-acting β₂-agonist (LABA), & long-acting muscarinic antagonist (LAMA), or on a combination of LABA & LAMA if ICS is not appropriate.

SC For initial 400-mg dose, administer two 200-mg inj consecutively in different inj sites. For initial 600-mg dose, administer two 300-mg inj consecutively in different inj sites. Atopic dermatitis Adult Initially 600 mg, followed by 300 mg every other wk. Adolescent 12-17 yr, weighing ≥60 kg Initially 600 mg, followed by 300 mg every other wk, <60 kg Initially 400 mg, followed by 200 mg every other wk. Childn 6-11 yr, weighing ≥60 kg Initially 600 mg, followed by 300 mg every other wk, 15 to <60 kg Initially 300 mg on day 1, followed by 300 mg on day 15. Subsequent doses: 300 mg every 4 wk, starting 4 wk after day 15 dose. Dose may be increased to 200 mg every other wk. Childn 6 mth to 5 yr, weighing 15 to <30 kg Initially 300 mg, followed by 300 mg every 4 wk, 5 to <15 kg Initially 200 mg, followed by 200 mg every 4 wk. Asthma Adult & adolescent ≥12 yr Initially 400 mg, followed by 200 mg every other wk. Adult & adolescent ≥12 yr w/ severe asthma & who are on oral corticosteroids; adult & adolescent ≥12 yr w/ severe asthma & co-morbid moderate to severe atopic dermatitis; adult w/ co-morbid severe CRSwNP Initially 600 mg, followed by 300 mg every other wk. Childn 6-11 yr, weighing ≥60 kg 200 mg every other wk, 30 to <60 kg 200 mg every other wk, or 300 mg every 4 wk, 15 to <30 kg 300 mg every 4 wk. CRSwNP Adult Initially 300 mg, followed by 300 mg every other wk. Prurigo nodularis Adult Initially 600 mg, followed by 300 mg every other wk. Eosinophilic esophagitis Adult & adolescent ≥12 yr, weighing ≥40 kg 300 mg every wk. COPD Adult 300 mg every other wk.

Hypersensitivity.

Should not be used to treat acute symptoms or acute exacerbations of asthma or COPD; acute bronchospasm or status asthmaticus. Discontinue immediately if systemic hypersensitivity reaction (immediate or delayed) occurs. Reports of eosinophilic conditions in adult asthma patients; conjunctivitis, dry eye, & keratitis-related events, predominantly in atopic dermatitis patients. Patients w/ pre-existing helminth infections should be treated before initiating dupilumab. Patients w/ co-morbid asthma should not adjust/stop asthma treatments w/o consultation & should be carefully monitored following dupilumab discontinuation. Avoid concurrent use of live & live attenuated vaccines. Rotate inj site w/ each inj. Do not inj into tender, damaged, bruised or scarred skin. Very limited data available in patients w/ severe renal impairment. No data available in patients w/ hepatic impairment. Should be used during pregnancy only if potential benefit justifies potential risk to foetus. Discontinue breast-feeding or discontinue dupilumab therapy during lactation. Safety & efficacy have not been established in childn <6 mth w/ atopic dermatitis; childn weighing <5 kg; childn <6 yr w/ severe asthma; childn <18 yr w/ CRSwNP; childn <18 yr w/ prurigo nodularis; childn <12 yr w/ eosinophilic esophagitis; childn <18 yr w/ COPD.

Inj site reactions (includes erythema, oedema, pruritus, pain, swelling), conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, eosinophilia. Eosinophilic esophagitis & COPD: Inj site bruising. COPD: Inj site induration, inj site rash, inj site dermatitis.

Antiasthmatic & COPD Preparations / Nasal Decongestants & Other Nasal Preparations / Other Dermatologicals

D11AH05 - dupilumab ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.

P₁S₁S₃