Drug Action
Dupilumab is a recombinant human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling.
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Drug reference
Dupilumab is a recombinant human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling.
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Moderate-to-severe atopic eczema (initiated by a specialist) ▶BY SUBCUTANEOUS INJECTION ▶Adult: Initially 600 mg, followed by 300 mg every 2 weeks, the initial dose should be administered as two consecutive 300 mg injections at different injection sites, review treatment if no response after 16 weeks Severe asthma with type 2 inflammation [add-on maintenance therapy] (initiated by a specialist) ▶BY SUBCUTANEOUS INJECTION ▶Adult: Initially 400 mg, followed by 200 mg every 2 weeks, the initial dose should be administered as two consecutive 200 mg injections at different injection sites, review need for treatment yearly Severe asthma with type 2 inflammation [add-on maintenance therapy for patients currently treated with oral corticosteroids or patients with co-morbid moderate-to-severe atopic dermatitis] (initiated by a specialist) ▶BY SUBCUTANEOUS INJECTION ▶Adult: Initially 600 mg, followed by 300 mg every 2 weeks, the initial dose should be administered as two consecutive 300 mg injections at different injection sites, review need for treatment yearly
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Helminth infection Skin CAUTIONS, FURTHER INFORMATION ▶Risk of infection Dupilumab may influence the immune response to helminth infections. Resolve pre-existing infection before initiating treatment; suspend treatment if resistant infection develops during therapy. Manufacturer advises patients should be brought up-to- date with live and live attenuated vaccines before initiating treatment.
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Dupilumab is a biological medicine. Biological medicines must be prescribed and dispensed by brand name, see Biological medicines and Biosimilar medicines, under Guidance on prescribing p. 1; manufacturer advises to record the brand name and batch number after each administration. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C) and protect from light; pre-filled syringes may be kept at room temperature (max. 25°C) for max. 14 days.
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NICE decisions ▶Dupilumab for treating moderate to severe atopic dermatitis (August 2018) NICE TA534 Dupilumab (Dupixent ®) is recommended as an option for treating moderate to severe atopic dermatitis in adults, only if: . the disease has not responded to at least 1 other systemic therapy, such as ciclosporin, methotrexate, azathioprine, and mycophenolate mofetil, or these are contra-indicated or not tolerated, and . the manufacturer provides dupilumab according to the commercial arrangement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta534 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2011 The Scottish Medicines Consortium has advised (September 2018) that dupilumab (Dupixent ®) is accepted for restricted use within NHS Scotland for the treatment of moderate- to-severe atopic dermatitis in adults who have had an inadequate response to existing systemic immunosuppressants such as ciclosporin, or in whom such treatment is considered unsuitable. This advice is Skin contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Eosinophilia. eye inflammation. eye pruritus. headache. oral herpes ▶Rare or very rare Hypersensitivity ▶Frequency not known Pneumonia eosinophilic. vasculitis SIDE-EFFECTS, FURTHER INFORMATION Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) Churg-Strauss syndrome has occurred in patients given dupilumab; the reaction may be associated with the reduction of oral corticosteroid therapy. Churg- Strauss syndrome can present as vasculitic rash, cardiac complications, worsening pulmonary symptoms, or peripheral neuropathy in patients with eosinophilia.
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Manufacturer advises use only if potential benefit outweighs risk—limited information available.
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Manufacturer advises avoid—no information available.
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Manufacturer advises to inject into the thigh or abdomen (except for the 5 cm around the navel), or upper arm (if not self-administered); rotate injection site and avoid skin that is tender, damaged or scarred. Patients may self-administer Dupixent ® after appropriate training in preparation and administration.
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There can be variation in the licensing of different medicines containing the same drug. Solution for injection EXCIPIENTS: May contain Polysorbates A ▶Dupixent (Sanofi) Dupilumab 150 mg per 1 ml Dupixent 300mg/2ml solution for injection pre-filled syringes | 2 pre-filled disposable injection P £1,264.89 Dupixent 300mg/2ml solution for injection pre-filled pens | 2 pre- filled disposable injection P £1,264.89 Dupilumab 175 mg per 1 ml Dupixent 200mg/1.14ml solution for injection pre-filled syringes | 2 pre-filled disposable injection P £1,264.89 Dupixent 200mg/1.14ml solution for injection pre-filled pens | 2 pre- filled disposable injection P £1,264.89
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Initially 600 mg, followed by 300 mg every
First-line fragment. Read the complete Indications and Dose section above.
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Initially 400 mg, followed by 200 mg every
First-line fragment. Read the complete Indications and Dose section above.
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Initially 600 mg, followed by 300 mg every
First-line fragment. Read the complete Indications and Dose section above.
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