Reslizumab

CINQAIR ® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype. 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. 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. Limitations of Use: CINQAIR is not indicated for: treatment of other eosinophilic conditions relief of acute bronchospasm or status asthmaticus

Reslizumab is an interleukin-5 antagonist (IgG4, kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Reslizumab binds to IL-5 with a dissociation constant of 81 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil surface. Inflammation is an important component in the pathogenesis of asthma. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation. Reslizumab, by inhibiting IL-5 signaling, reduces the production and survival of eosinophils, however, the mechanism of reslizumab action in asthma has not been definitively established.

CINQAIR is for intravenous infusion only. Do not administer as an intravenous push or bolus. CINQAIR should be administered by a healthcare professional prepared to manage anaphylaxis. Recommended dosage regimen is 3 mg/kg once every 4 weeks by intravenous infusion over 20-50 minutes

CINQAIR is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients. Known hypersensitivity to reslizumab or any of its excipients

Boxed warning (anaphylaxis): Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR. Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Malignancy: Malignancies were observed in clinical studies. Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Decrease corticosteroids gradually, if appropriate. Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with CINQAIR.

The following adverse reactions are discussed in other sections of the labeling: Anaphylaxis Malignancy The most common adverse reaction (incidence greater than or equal to 2%) includes oropharyngeal pain.

No formal clinical drug interaction studies have been performed with CINQAIR.

Storage and Stability: Refrigerate at 2 ºC to 8ºC (36°F to 46°F). Do not freeze. Do not shake.