depemokimab
Drug Details
- Generic Name
- depemokimab
- Brand Names
- Exdensur
- Application Number
- BLA761458
- Sponsor
- GlaxoSmithKline LLC
- NDC Codes
- 2
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- SUBCUTANEOUS
- Active Ingredients
- DEPEMOKIMAB
Indications and Usage
1 INDICATIONS AND USAGE EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] . EXDENSUR is an interleukin‑5 (IL-5) antagonist, a monoclonal antibody (humanized immunoglobulin G [IgG]1 kappa) indicated for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. ( 1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. ( 1 )