Dupilumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Atopic dermatitis Initial: 600 mg followed by 300 mg every other week. Asthma Initial: 400 mg followed by 200 mg every other week. Patients with severe asthma on oral corticosteroids or co-morbid moderate to severe atopic dermatitis: Initial: 600 mg followed by 300 mg every other week.
Dosage Details
Subcutaneous
Atopic dermatitis
Adult: Moderate to severe cases: Initially, 600 mg (given as 2 inj of 300 mg at different inj sites), followed by 300 mg every other week. Consider treatment discontinuation if there is no response after 16 weeks.
Child: 12-17 years <60 kg: Initially, 400 mg (given as 2 inj of 200 mg), followed by 200 mg every other week; ≥60 kg: Same as adult dose. Consider treatment discontinuation if there is no response after 16 weeks.

Subcutaneous
Asthma
Adult: Initially, 400 mg (given as 2 inj of 200 mg) followed by 200 mg every other week. For patient with severe asthma on oral corticosteroids or co-morbid moderate to severe atopic dermatitis: Initially, 600 mg (given as 2 inj of 300 mg at different inj sites), followed by 300 mg every other week.
Child: ≥12 years Same as adult dose.
Contraindications
Concurrent administration of live vaccines.
Special Precautions
Patients with asthma (who are treated for atopic dermatitis), helminth infection. Not intended for treatment of acute asthma symptoms or acute exacerbations, status asthmaticus or acute bronchospasm. Gradually reduce the dose of systemic, topical or inhaled corticosteroids upon initiation of dupilumab treatment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. urticaria, rash, erythema nodosum), eosinophilia, vasculitis, ocular effects (e.g. conjunctivitis, keratitis).
Eye disorders: Eye pruritus, blepharitis, dry eye.
General disorders and administration site conditions: Inj site reactions (e.g. erythema, oedema, pain, pruritus).
Immune system disorders: Rarely, serum sickness/serum sickness-like reactions.
Infections and infestations: Herpes simplex infection.
Nervous system disorders: Headache.
MonitoringParameters
Monitor for signs and symptoms of hypersensitivity reactions and infection.
Drug Interactions
Potentially Fatal: May enhance the adverse or toxic effects of live vaccines.
Action
Description: Dupilumab is a human monoclonal IgG4 antibody that binds to IL-4Rα to block interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling. IL-4Rα (e.g. mast cells, eosinophils, macrophages, lymphocytes, epithelial cells, goblet cells) are involved in inflammation. Blockage of IL-4Rα thereby inhibits IL-4 and IL-13 cytokine-induced inflammatory responses including the release of pro-inflammatory cytokines, chemokines, nitric oxide, and IgE.
Pharmacokinetics:
Absorption: Bioavailability: 61-64%. Time to peak plasma concentration: Approx 1 week.
Distribution: Volume of distribution: Approx 4.8 ± 1.3 L.
Metabolism: Catabolised to small peptides and amino acids.
Storage
Store between 2-8°C; prefilled syringe may be stored below 25°C for up to 14 days, if necessary. Do not freeze. Protect from light.
ATC Classification
D11AH05 - dupilumab ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.
References
Anon. Dupilumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/09/2019.

Buckingham R (ed). Dupilumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/09/2019.

Dupixent Injection, Solution (Sanofi-Aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 04/09/2019.

Joint Formulary Committee. Dupilumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/09/2019.

Disclaimer: This information is independently developed by MIMS based on Dupilumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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