Depemokimab

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. EXDENSUR is an interleukin‑5 (IL‑5) antagonist, a monoclonal antibody (humanized immunoglobulin G1 [IgG1] 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. Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus.

Depemokimab‑ulaa is an IL‑5 antagonist (humanized IgG1 kappa monoclonal antibody), which binds to IL‑5 with a dissociation constant of 10.5 pM, inhibiting the bioactivity of IL‑5 with in vitro IC50 value of 4 pM by blocking its binding to the alpha chain of the IL‑5 receptor complex expressed on the cell surface. Depemokimab‑ulaa contains a triple amino acid substitution (YTE) in the fragment crystallizable (Fc) region which increases binding to the neonatal Fc receptor and thereby extends the elimination half‑life. These properties support the dosing interval of every 6 months. IL‑5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Inflammation is an important component in the pathogenesis of asthma.

The recommended dosage is 100 mg administered once every 6 months by subcutaneous injection into the upper arm, thigh, or abdomen. • EXDENSUR should be administered by a healthcare provider. • See full prescribing information for preparation and administration instructions.

None. None.

• Hypersensitivity reactions, including anaphylaxis, can occur after administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy. • Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of therapy with EXDENSUR. Reduce corticosteroid dose gradually, if appropriate. • Treat pre-existing helminth infections before initiating therapy with EXDENSUR. If patients become infected while receiving treatment with EXDENSUR and do not respond to anti‑helminth treatment, discontinue EXDENSUR until the parasitic infection resolves.

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity Reactions. The most common adverse reactions (incidence ≥4%) are upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, and pharyngitis.

Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze. The prefilled syringe can be removed from the refrigerator and kept in the unopened carton, protected from light for up to 7 days at room temperature up to 86°F (30°C). Discard if left out of the refrigerator for more than 7 days. Do not shake.