benralizumab
benralizumab is listed in the FDA National Drug Code directory with 1 NDC code. Available dosage form: liquid.
Drug Details
- Generic Name
- benralizumab
- Brand Names
- N/A
- Application Number
- Sponsor
- AstraZeneca Pharmaceuticals LP
- NDC Codes
- 1
- Dosage Forms
- LIQUID
- Routes
- N/A
- Active Ingredients
- BENRALIZUMAB
Indications and Usage
1 INDICATIONS AND USAGE FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for: • add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. ( 1.1 ) • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). ( 1.2 ) • treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. ( 1.3 ) Limitations of Use : Not for relief of acute bronchospasm or status asthmaticus. (1.1) 1.1 Asthma FASENRA 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. Limitations of Use: • FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus. 1.2 Eosinophilic Granulomatosis with Polyangiitis FASENRA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 1.3 Hypereosinophilic Syndrome FASENRA is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause.