Dupixent

Dupixent

dupilumab

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
Dupilumab
Indications/Uses
Add-on maintenance treatment for severe asthma w/ type 2 inflammation characterized by elevated blood eosinophils &/or FeNO in patients ≥6 yr. Maintenance therapy for oral corticosteroid-dependent asthma. Add-on maintenance treatment in adult patients w/ inadequately controlled severe chronic rhinosinusitis w/ nasal polyposis (CRSwNP). 100 mg: Moderate-to-severe atopic dermatitis in patients ≥6 yr who require chronic treatment & whose disease is not adequately controlled or not advisable w/ topical prescription therapies; can be used w/ or w/o topical corticosteroids. 200 mg & 300 mg: Moderate-to-severe atopic dermatitis in adults & ped patients ≥6 mth who require chronic treatment & whose disease is not adequately controlled or not advisable w/ topical prescription therapies; can be used w/ or w/o topical corticosteroids. Moderate-to-severe prurigo nodularis (PN) in adult patients whose disease is not adequately controlled or not advisable w/ topical prescription therapies; can be used w/ or w/o topical corticosteroids.
Dosage/Direction for Use
SC Atopic dermatitis Adult Initially 600 mg (two 300 mg inj) followed by 300 mg every other wk. Ped 6-17 yr weighing ≥60 kg Initially 600 mg (two 300 mg inj) followed by 300 mg every other wk, 30 to <60 kg Initially 400 mg (two 200 mg inj) followed by 200 mg every other wk, 15 to <30 kg Initially 600 mg (two 300 mg inj) followed by 300 mg every 4 wk. Ped 6 mth to 5 yr weighing 15 to <30 kg 300 mg every 4 wk, 5 to <15 kg 200 mg every 4 wk. Asthma Adult & adolescent ≥12 yr Initially 400 mg (two 200 mg inj) followed by 200 mg every other wk. Patient w/ oral corticosteroid-dependent asthma, w/ co-morbid moderate-to-severe atopic dermatitis or adult w/ co-morbid severe CRSwNP Initially 600 mg (two 300 mg inj) followed by 300 mg every other wk. Ped 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 100 mg every other wk or 300 mg every 4 wk. CRSwNP Adult 300 mg every other wk. PN Adult Initially 600 mg (two 300 mg inj) followed by 300 mg every other wk.
Contraindications
Special Precautions
Institute appropriate therapy & discontinue use if clinically significant hypersensitivity reaction occurs. Rotate inj site w/ each inj; do not inj into tender, damaged, bruised or scarred skin. Possible conjunctivitis & keratitis; advise patients to report new onset or worsening eye symptoms; consider ophthalmological exam for patients who develop conjunctivitis that does not resolve following standard treatment or sign & symptoms suggestive of keratitis. Observe for vasculitic rash, worsening pulmonary symptoms, cardiac complications &/or neuropathy presenting in patients w/ eosinophilia. Not to be used for acute asthma symptoms or acute exacerbations; acute bronchospasm or status asthmaticus. Do not abruptly discontinue systemic, topical or inhaled corticosteroids upon initiation of Dupixent. Advise patients w/ atopic dermatitis or CRSwNP who have co-morbid asthma not to adjust or stop asthma treatment w/o consultation. Possible arthralgia; advise patients to report new onset or worsening joint symptoms; consider rheumatological evaluation &/or therapy discontinuation if symptoms persist or worsen. Treat patients w/ pre-existing helminth infections before initiating therapy; discontinue use until infection resolves in patients who become infected while receiving treatment & do not respond to antihelminthics. Avoid use of live vaccines. Co-administration w/ non-live vaccines. Pregnancy & lactation. Possible enterobiasis & ascariasis in ped patients 6-11 yr. Childn <6 yr w/ asthma; <18 yr w/ CRSwNP. 100 mg: Childn <6 yr w/ atopic dermatitis. 200 mg & 300 mg: Childn <6 mth w/ atopic dermatitis; <18 yr w/ PN.
Adverse Reactions
Inj site reactions; conjunctivitis. Atopic dermatitis: Blepharitis, oral herpes, keratitis, eye pruritus, other HSV infection, dry eye. Asthma: Oropharyngeal pain, eosinophilia. CRSwNP: Arthalgia, gastritis, insomnia, toothache.
Drug Interactions
Avoid use w/ live vaccines. Co-administration w/ non-live vaccines.
MIMS Class
Antiasthmatic & COPD Preparations / Other Dermatologicals
ATC Classification
D11AH05 - dupilumab ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.
Presentation/Packing
Form
Dupixent soln for inj 100 mg/0.67 mL
Packing/Price
2 × 1's
Form
Dupixent soln for inj 200 mg/1.14 mL
Packing/Price
2 × 1's
Form
Dupixent soln for inj 300 mg/2 mL
Packing/Price
2 × 1's
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