Reslizumab

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. 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 )

CINQAERO is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment (see section 5.

1).

26 CINQAIR Product Monograph Page 3 of 30 PrCINQAIR™ Reslizumab PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Intravenous infusion Concentrate for solution for intravenous infusion 100 mg in 10 mL vial Sodium, sucrose, For a complete listing, see Dosage Forms, Composition, and Packaging section.

DESCRIPTION CINQAIR™ (reslizumab) is a humanized IgG4κ monoclonal antibody that binds to human interleukin-5 (IL-5). Reslizumab has a molecular weight of approximately 147 kDa. Reslizumab is produced by recombinant DNA technology in a mammalian cell expression system.

INDICATIONS AND CLINICAL USE CINQAIR™ (reslizumab) is indicated as an add-on maintenance treatment of adult patients with severe eosinophilic asthma who:  are inadequately controlled with medium-to-high-dose inhaled corticosteroids and an additional asthma controller(s) (eg, LABA) and  have a blood eosinophil count of ≥400 cells/μL at initiation of the treatment.