Dupilumab: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

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.

Monitoring Parameters

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.

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 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.

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