NUCALA should be prescribed by a specialist experienced in the diagnosis and treatment of severe eosinophilic asthma.
NUCALA should only be administered as a subcutaneous injection (see Special precautions for disposal and other handling and Instructions for Use under Cautions for Usage).
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.
Posology: Severe Eosinophilic asthma: Adults and Adolescents (12 years and older): The recommended dose is 100 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks.
The safety and efficacy of NUCALA have not been established in adolescents weighing less than 45kg.
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.
Children (up to 12 years of age): The safety and efficacy of NUCALA have not been established in children less than 12 years of age.
Eosinophilic Granulomatosis with Polyangiitis (EGPA): Injection sites should be at least 5 cm apart (see Special precautions for disposal and other handling and Instructions for Use under Cautions for Usage).
Adults: The recommended dose is 300 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks.
Children and adolescents under 18 years of age: The safety and efficacy of Nucala has not been tested in adolescents and children with EGPA who are under 18 years of age.
Chronic Rhinosinusitis with Nasal Polyps (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.
Children: The safety and efficacy in children with CRSwNP below the age of 18 years have not been established. No data are available.
Elderly (65 years or older): No dosage adjustment is recommended in patients 65 years or older (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Renal Impairment: Dose adjustments in patients with renal impairment are unlikely to be required (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Hepatic Impairment: Dose adjustments in patients with hepatic impairment are unlikely to be required (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).