Nucala Dosage/Direction for Use

Nucala should be prescribed by physicians experienced in the diagnosis and treatment of severe refractory eosinophilic asthma, CRSwNP, EGPA or HES.
Posology: Severe eosinophilic asthma: Adults and adolescents aged 12 years and over: The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Nucala is intended for long-term treatment. The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient's disease severity and level of control of exacerbations.
CRSwNP: Adults: The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Nucala is intended for long-term treatment. Consideration can be given to alternative treatments in patients who have shown no response after 24 weeks of treatment for CRSwNP. Some patients with initial partial response may subsequently improve with continued treatment beyond 24 weeks.
EGPA: Adults: The recommended dose of mepolizumab is 300 mg administered subcutaneously once every 4 weeks.
Nucala 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 Nucala has not been studied in this population.
HES: Adults: The recommended dose of mepolizumab is 300 mg administered subcutaneously once every 4 weeks.
Nucala 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 level of symptom control.
Patients who develop life-threatening manifestations of HES should also be evaluated for the need for continued therapy, as Nucala has not been studied in this population.
Special populations: Elderly patients: No dose adjustment is required for elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Renal and hepatic impairment: No dose adjustment is required in patients with renal or hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Severe eosinophilic asthma: Children less than 12 years old: The safety and efficacy of mepolizumab in children and adolescents less than 12 years old have not yet been established.
CRSwNP: Children less than 18 years old: The safety and efficacy in children with CRSwNP below the age of 18 years have not been established. No data are available.
EGPA: Children less than 18 years old: The safety and efficacy of mepolizumab has not been established in children below the age of 18 years old. No data are available.
HES: Children aged less than 18 years old: The safety and efficacy of mepolizumab in children and adolescents aged less than 18 years old have not yet been established.
Currently available data are described in Adverse Reactions, and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Method of administration: The Nucala pre-filled pen should be used for subcutaneous injection only.
Nucala may be self-administered by the patient or administered by a caregiver if their healthcare professional determines that it is appropriate, and the patient or caregiver are trained in injection techniques.
For self-administration, the recommended injection sites are the abdomen or thigh. A caregiver can also inject Nucala into the upper arm.
For doses which require more than one injection, it is recommended that each injection is administered at least 5 cm apart.
Comprehensive instructions for subcutaneous administration of Nucala in a pre-filled pen are provided in the instructions for use under Patient Counselling Information.