What is the generic name?

MEPOLIZUMAB

What is the Trade Name for MEPOLIZUMAB?

Nucala

What are the Indications for MEPOLIZUMAB?

• 1 INDICATIONS AND USAGE NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for: ‚Ä¢ Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. ( 1.1 ) ‚Ä¢ Add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 ) ‚Ä¢ The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). ( 1.3 ) ‚Ä¢ The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ‚â•6 months without an identifiable non hematologic secondary cause. ( 1.4 ) Limitations of use: Not for relief of acute bronchospasm or status asthmaticus. ( 1.1 ) 1.1 Maintenance Treatment of Severe Asthma NUCALA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype [see Use in Specific Populations ( 8.4 ), Clinical Studies ( 14.1 )] . Limitations of Use NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus. 1.2 Maintenance Treatment of Chronic Rhinosinusitis with Nasal Polyps NUCALA is indicated for the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. 1.3 Eosinophilic Granulomatosis with Polyangiitis NUCALA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 1.4 Hypereosinophilic Syndrome NUCALA is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ‚â•6 months without an identifiable non-hematologic secondary cause.

References: https://open.fda.gov/