Dupilumab (CRSwNP)

PAGE SCOPE: this page is dupilumab for chronic rhinosinusitis with nasal polyps, and the figure above is the CRSwNP dose only — none of the other licensed indications (atopic dermatitis, asthma, eosinophilic oesophagitis, chronic spontaneous urticaria, prurigo nodularis, COPD, bullous pemphigoid, allergic fungal rhinosinusitis) is dosed here. WHERE THE DOSE COMES FROM: the UK SPC in this bundle (Dupixent 200 mg pre-filled pen) contains NO standalone CRSwNP posology section — CRSwNP appears in it only as a co-morbidity that raises the ASTHMA dose, verbatim: 'For patients with severe asthma and who are on oral corticosteroids or for patients with severe asthma and co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid severe chronic rhinosinusitis with nasal polyposis, an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week administered as subcutaneous injection.' The dose published above is therefore the US label, section 2.5 verbatim: 'Chronic Rhinosinusitis with Nasal Polyps ( 2.5 ): Recommended dosage for adult and pediatric patients 12 years of age and older is 300 mg given every 2 weeks (Q2W).' THE LOADING-DOSE QUESTION, RESOLVED AS FAR AS THIS BUNDLE ALLOWS: a previous pass was held because the two labels looked as though they disagreed about a 600 mg load. They do not — they are describing different indications. The UK 600 mg sentence is the ASTHMA posology for a patient who also has severe CRSwNP; it is not a CRSwNP posology, and the UK SPC in this bundle has none. Within the US label the omission is deliberate rather than an artefact of truncation: its Highlights dosage lines are self-contained, and the sibling lines for atopic dermatitis, prurigo nodularis, chronic spontaneous urticaria and bullous pemphigoid all spell out 'an initial dose of 600 mg (two 300 mg injections), followed by 300 mg', whereas CRSwNP, COPD and adult allergic fungal rhinosinusitis are each given as a plain '300 mg given every 2 weeks (Q2W)'. Residual limitation: only the Highlights line for section 2.5 was retrieved and the body of that subsection was cut at the source-fetch limit, and the UK SPC for the 300 mg presentation was never fetched — so confirm the UK initiation regimen against that SPC before UK use. PRESENTATIONS (US section 3, verbatim): single-dose pre-filled syringe with needle shield and single-dose pre-filled pen, 'Injection: 300 mg/2 mL (150 mg/mL)' and 'Injection: 200 mg/1.14 mL (175 mg/mL)'. DEVICE AGE LIMITS (UK 4.2): 'The dupilumab pre-filled pen is for use in adult and paediatric patients aged 2 years and older. The dupilumab pre-filled syringe is for use in adult and paediatric patients aged 6 months and older.' MISSED DOSE (UK 4.2, verbatim): 'If an every other week dose is missed, administer the injection within 7 days from the missed dose and then resume the patient's original schedule. If the missed dose is not administered within 7 days, wait until the next dose on the original schedule.' ELDERLY (UK 4.2): 'No dose adjustment is recommended for elderly (>= 65 years) patients.' INITIATION (UK 4.2): 'Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of conditions for which dupilumab is indicated.' CORTICOSTEROIDS (UK 4.4): 'It is recommended that systemic, topical, or inhaled corticosteroids should not be discontinued abruptly upon initiation of therapy with dupilumab.' The 16-week response-review rule in the UK SPC is stated for ATOPIC DERMATITIS only and has not been carried across to this CRSwNP page.

FLAT DOSE, NOT WEIGHT-BASED — dosePerKg is deliberately null. US label section 2.5 verbatim: 'Chronic Rhinosinusitis with Nasal Polyps ( 2.5 ): Recommended dosage for adult and pediatric patients 12 years of age and older is 300 mg given every 2 weeks (Q2W)' — i.e. the same 300 mg Q2W dose from 12 years of age upward, with no per-kg or weight-banded schedule for this indication. Weight-banded schedules DO exist in this label for other indications (atopic dermatitis, asthma, eosinophilic oesophagitis, chronic spontaneous urticaria, allergic fungal rhinosinusitis) and must NOT be transferred to CRSwNP. The UK SPC in this bundle carries no CRSwNP posology at all, so no UK paediatric age limit for CRSwNP can be quoted from it. Concentration 150 mg/mL is the 300 mg/2 mL presentation (US section 3: 'Injection: 300 mg/2 mL (150 mg/mL)'); the 200 mg presentation is a different concentration (200 mg/1.14 mL, 175 mg/mL) and is not the one used for a 300 mg dose. Device limits (UK 4.2): pre-filled pen from 2 years, pre-filled syringe from 6 months; 'In children 12 years of age and older, it is recommended that dupilumab is administered by or under supervision of an adult.' Verify any under-18 use against a children's formulary.