Dupixent

Dupilumab

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-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 corticosteroid (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 adults w/ severe chronic rhinosinusitis w/ nasal polyposis (CRSwNP) 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.

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 chronic rhinosinusitis w/ nasal polyposis 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.

Hypersensitivity.

Should not be used to treat acute asthma symptoms or acute exacerbations; acute bronchospasms 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/ comorbid asthma should not adjust/stop asthma treatments w/o consultation; carefully monitor following dupilumab discontinuation. Avoid concurrent use of live & live attenuated vaccines. No data available in patients w/ hepatic impairment. Very limited data available in patients w/ severe renal impairment. Should be used during pregnancy only if potential benefit justifies potential risk to the foetus. Discontinue breast-feeding or discontinue dupilumab therapy during lactation. Safety & efficacy have not been established in childn <6 mth w/ atopic dermatitis; childn w/ body wt <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.

Inj site reactions (includes erythema, oedema, pruritus, pain, swelling), conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, eosinophilia. Eosinophilic esophagitis: Inj site bruising.

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.

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