Reslizumab

FDA Drug Profile — CINQAIR

Drug Details

Generic Name
Reslizumab
Brand Names
CINQAIR
Application Number
BLA761033
Sponsor
Teva Respiratory, LLC
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients
RESLIZUMAB

Indications and Usage

1 INDICATIONS AND USAGE CINQAIR ® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies ( 14 )] . Limitation of Use: CINQAIR is not indicated for treatment of other eosinophilic conditions. CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] . CINQAIR is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype ( 1 ). Limitations of Use : CINQAIR is not indicated for: treatment of other eosinophilic conditions ( 1 ) relief of acute bronchospasm or status asthmaticus ( 1 )