Mepolizumab (Eosinophilic GPA)

Fetched UK SPC: Nucala 100 mg powder for solution for injection (eMC product 1938). It is recommended that Nucala is prescribed by physicians experienced in the diagnosis and treatment of severe refractory eosinophilic asthma, CRSwNP, COPD, EGPA or HES. The 300 mg EGPA dose requires more than one injection; it is recommended that each injection is administered at least 5 cm apart. The powder should be reconstituted prior to administration and the reconstituted solution used immediately; each vial is for a single patient and any remainder discarded. Nucala is intended for long-term treatment — the need for continued therapy is to be reviewed at least on an annual basis as determined by physician assessment of disease severity and improvement of symptom control. Patients who develop life-threatening manifestations of EGPA must also be evaluated for the need for continued therapy, as Nucala has not been studied in that population. Other indications in the same SPC: severe eosinophilic asthma in adults and adolescents aged 12 years and older, 100 mg once every 4 weeks (children aged 6 to 11 years, 40 mg once every 4 weeks); CRSwNP in adults, 100 mg once every 4 weeks; COPD in adults, 100 mg once every 4 weeks; HES in adults, 300 mg once every 4 weeks. No dose adjustment is required for elderly patients aged 65 years and over. Paediatric EGPA (the SPC gives fixed weight-band doses, not a per-kg dose, so paedDose is null): children aged 6 to 11 years weighing 40 kg or more, 200 mg subcutaneously once every 4 weeks; children aged 6 to 11 years weighing less than 40 kg, 100 mg subcutaneously once every 4 weeks; the posology in children and adolescents aged 6 to 17 years with EGPA was supported by modelling and simulation data. Safety and efficacy in EGPA have not been established in children below 6 years of age and no data are available. Verify any under-18 use against a children's formulary.