Active Ingredient: Mepolizumab
Mepolizumab is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 300 milligrams mepolizumab, once every 4 weeks.
The recommended dose of mepolizumab is 300 mg administered subcutaneously once every 4 weeks.
The posology of mepolizumab in adolescents with EGPA was supported by modelling and simulation data.
Mepolizumab is intended for long-term treatment. The need for continued therapy should be reviewed at least on an annual basis as determined by physician assessment of the patient’s disease severity and improvement of symptom control.
Patients who develop life-threatening manifestations of EGPA should also be evaluated for the need for continued therapy, as mepolizumab has not been studied in this population.
Mepolizumab is for subcutaneous injection only and should be administered by a healthcare professional. It may be injected into the upper arm, thigh, or abdomen.
For doses which require more than one injection, it is recommended that each injection is administered at least 5 cm apart.
For:
Regimen A: In case that patient age in years is ≥ 6 and patient weight is ≥ 40 kg, subcutaneous, 200 milligrams mepolizumab, once every 4 weeks.
Regimen B: In case that patient age in years is ≥ 6 and patient weight is < 40 kg, subcutaneous, 100 milligrams mepolizumab, once every 4 weeks.
The posology of mepolizumab in children with EGPA was supported by modelling and simulation data.
Children aged 6 to 11 years old weighing ≥40 kg: The recommended dose of mepolizumab is 200 mg administered subcutaneously once every 4 weeks.
Children aged 6 to 11 years old weighing <40 kg: The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Mepolizumab is intended for long-term treatment. The need for continued therapy should be reviewed at least on an annual basis as determined by physician assessment of the patient’s disease severity and improvement of symptom control.
Patients who develop life-threatening manifestations of EGPA should also be evaluated for the need for continued therapy, as mepolizumab has not been studied in this population.
Mepolizumab is for subcutaneous injection only and should be administered by a healthcare professional. It may be injected into the upper arm, thigh, or abdomen.
For doses which require more than one injection, it is recommended that each injection is administered at least 5 cm apart.
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