Abbreviated Prescribing Information
TEZSPIRE PEN (Tezepelumab)

Presentaton: Tezepelumab 210 mg in 1.91 mL (110 mg/mL) soluton for injection in pre-filled pen. Indications: Add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Dosage: Subcutaneous injection every 4 weeks. Contraindications: Hypersensitivity to the active substance or to any of the excipients (Glacial acetic acid, L-proline, Polysorbate 80, Sodium hydroxide, Water for injection.) Precautions: Should not be used to treat acute asthma exacerbations; Seek medical advice if asthma remains uncontrolled or worsens after initiation of treatment; Abrupt discontinuation of corticosteroids after initiation of Tezepelumab is not recommended. Reduction in corticosteroid doses should be gradual and performed under the supervision of a physician; Patients with pre-existing serious infections or helminth infections should be treated before initiating therapy with Tezepelumab; In the event of a serious hypersensitivity reaction (e.g. anaphylaxis), administration of Tezepelumab should be discontinued immediately and appropriate treatment as clinically indicated should be initiated; If patients develop a serious cardiac event while receiving Tezepelumab treatment, therapy with Tezepelumab should be discontinued until the acute event stabilises. Interactions: No formal drug interaction studies have been conducted. The use of live attenuated vaccines should be avoided in patients receiving Tezepelumab. Undesirable Effects: Arthralgia, pharyngitis, hypersensitivity (including anaphylactic reaction), rash and injection site reactions. Full local prescribing information is available upon request. API.HK.TEZ.0923 

HK-10909 03/10/2024