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Dupixent

Dupixent

dupilumab

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
Dupilumab
Indications/Uses
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. 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). 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. Add-on maintenance treatment for uncontrolled COPD characterized by raised blood eosinophils in adults who are on stable combination of an inhaled corticosteroid (ICS), long-acting β2-agonist (LABA) & long-acting muscarinic antagonist (LAMA), or on combination of LABA and LAMA if ICS is not appropriate.
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 & ped ≥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 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. COPD Adult 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 signs & 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 symptoms or exacerbations of asthma or COPD; acute bronchospasm or status asthmaticus. Do not abruptly discontinue systemic, topical or inhaled corticosteroids upon initiation of Dupixent. Advise patients w/ 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 mth w/ atopic dermatitis; <6 yr w/ asthma; <18 yr w/ CRSwNP, PN & COPD.
Adverse Reactions
Inj site reactions. Atopic dermatitis: Blepharitis, oral herpes, keratitis, eye pruritus, other HSV infection, dry eye. Asthma: Oropharyngeal pain. CRSwNP: Insomnia. COPD: Viral infection, headache, nasopharyngitis, back pain, diarrhea, UTI, rhinitis. CRSwNP & COPD: Arthralgia, gastritis, toothache. Atopic dermatitis, PN & CRSwNP: Conjunctivitis. Asthma, CRSwNP & COPD: Eosinophilia.
Drug Interactions
Avoid use w/ live vaccines. Co-administration w/ non-live vaccines.
MIMS Class
Antiasthmatic & COPD Preparations / Nasal Decongestants & Other Nasal 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 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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