Tezepelumab

TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

Tezepelumab-ekko is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody IgG2λ that binds to human TSLP with a dissociation constant of 15.8 pM and blocks its interaction with the heterodimeric TSLP receptor. TSLP is a cytokine mainly derived from epithelial cells and occupies an upstream position in inflammatory cascades. Airway and mucosal inflammation are important components of the pathogenesis of asthma and CRSwNP. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes, ILC2 cells) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in airway and mucosal inflammation. Increased levels of TSLP mRNA and protein are found in the airways of patients with asthma as well as in nasal polyp tissue.

Recommended dosage is 210 mg administered once every 4 weeks. • Administer by subcutaneous injection. • See full prescribing information for preparation and administration instructions.

TEZSPIRE is contraindicated in patients who have known hypersensitivity to tezepelumab-ekko or any of its excipients. Known hypersensitivity to tezepelumab-ekko or excipients.

• Hypersensitivity Reactions: Hypersensitivity reactions have been observed in the clinical trials (e.g., rash, allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. Initiate appropriate treatment as clinically indicated in the event of a hypersensitivity reaction. • Risk Associated with Abrupt Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Decrease corticosteroids gradually, if appropriate. • Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until the parasitic infection resolves. • Vaccination: Avoid use of live attenuated vaccines.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions Most common adverse reactions (incidence ≥ 3%) are: • Asthma: pharyngitis, arthralgia, and back pain. • Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia.

No formal drug interaction studies have been performed with TEZSPIRE.

Store refrigerated between 36°F to 46°F (2°C to 8°C). If necessary, TEZSPIRE may be kept at room temperature between 68°F to 77˚F (20°C to 25°C) for a maximum of 30 days. Do not put back in the refrigerator once TEZSPIRE has reached room temperature. After removal from the refrigerator, TEZSPIRE must be used within 30 days or discarded. Do not freeze. Store TEZSPIRE in original carton to protect from light until time of use. Do not shake.