Dupilumab


Generic Medicine Info
Indications and Dosage
Subcutaneous
Atopic dermatitis
Adult: Moderate to severe cases which are not adequately controlled with topical treatments, or when topical treatments are not advisable: Initially, 600 mg (given as two consecutive 300 mg inj at different inj sites), followed by 300 mg every other week. Consider treatment discontinuation if there is no response after 16 weeks. May be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used but reserved for problem areas only (e.g. face, neck, intertriginous or genital areas).
Child: Moderate to severe cases: 6-17 years 15-<30 kg: Initially, 600 mg (given as two 300 mg inj at different inj sites), followed by 300 mg every 4 weeks; 30-<60 kg: Initially, 400 mg (given as two 200 mg inj at different inj sites), followed by 200 mg every other week; ≥60 kg: Same as adult dose. Consider treatment discontinuation if there is no response after 16 weeks. Treatment and dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).

Subcutaneous
Asthma
Adult: As add-on maintenance therapy for severe asthma with type 2 inflammation characterised by elevated blood eosinophils and/or raised fraction of exhaled nitric oxide: Initially, 400 mg (given as two consecutive 200 mg inj at different inj sites), followed by 200 mg every other week. For patient with severe asthma on oral corticosteroids, or those with severe asthma with co-morbid moderate to severe atopic dermatitis or with co-morbid severe chronic rhinosinusitis with nasal polyposis: Initially, 600 mg (given as two consecutive 300 mg inj at different inj sites), followed by 300 mg every other week.
Child: ≥12 years Same as adult dose.

Subcutaneous
Chronic rhinosinusitis with nasal polyposis
Adult: As add-on maintenance therapy in patients with inadequately controlled cases: 300 mg once every other week. Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).

Subcutaneous
Eosinophilic oesophagitis
Adult: 300 mg once weekly. Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: ≥12 years ≥40 kg: Same as adult dose.
Contraindications
Hypersensitivity. Concurrent administration with live and live attenuated vaccines.
Special Precautions
Patient with co-morbid asthma (who are treated for atopic dermatitis or rhinosinusitis), helminth infection. Not indicated for the treatment of acute asthma symptoms or acute exacerbations, status asthmaticus or acute bronchospasm. Avoid abrupt discontinuation of systemic, inhaled, or topical corticosteroids upon initiation of dupilumab treatment; reduction of corticosteroid doses, if appropriate, must be done gradually. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. anaphylactic reaction, angioedema, urticaria, serum sickness or serum sickness-like reaction, erythema nodosum, erythema multiforme, rash), ocular effects (e.g. conjunctivitis, keratitis, blepharitis, eye pruritus, xerophthalmia); eosinophilic pneumonia, vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EPGA); arthralgia, including gait disturbances or decreased mobility associated with joint symptoms.
Blood and lymphatic system disorders: Eosinophilia, immune thrombocytopenia.
Gastrointestinal disorders: Gastritis, toothache.
General disorders and administration site conditions: Inj site reactions. (e.g. pain, pruritus, oedema, erythema).
Immune system disorders: Antibody development.
Infections and infestations: Oral herpes.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Oropharyngeal pain.
Skin and subcutaneous tissue disorders: Alopecia, facial erythema, psoriasis.
Monitoring Parameters
Perform pulmonary function tests when used for asthma. Monitor for signs and symptoms of hypersensitivity reactions, ocular effects, infections, and arthralgia.
Drug Interactions
Potentially Fatal: May enhance the adverse or toxic effects of live vaccines.
Action
Description:
Mechanism of Action: Dupilumab is a human monoclonal IgG4 antibody that blocks interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling by binding to the IL-4Rα subunit. Several cell types that express 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: Primarily distributed in the vascular system. Volume of distribution: Approx 4.8 ± 1.3 L.
Metabolism: Degraded into small peptides and amino acids.
Storage
Store between 2-8°C. Do not freeze. If needed, pre-filled pens or syringes may be stored below 25°C for up to 14 days; use within 14 days or discard after removal from refrigeration. Do not expose to heat. Protect from light and direct sunlight. Do not shake.
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.
References
Anon. Dupilumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/07/2022.

Buckingham R (ed). Dupilumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/07/2022.

Dupixent 200 mg Solution for Injection in Pre-filled Syringe (Aventis Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 07/07/2022.

Dupixent 200 mg, 300 mg Solution for Injection in Pre-filled Syringe (Sanofi-Aventis [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/07/2022.

Dupixent 200 mg, 300 mg Solution for Injection in Pre-filled Syringe (Sanofi-Aventis Singapore Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 19/07/2022.

Dupixent Injection, Solution (Sanofi-Aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/07/2022.

Joint Formulary Committee. Dupilumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/07/2022.

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 © 2024 MIMS. All rights reserved. Powered by MIMS.com
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