Tezspire

What it is

Tezspire contains tezepelumab 210 mg in 1.91 mL solution for injection, supplied as a prefilled syringe or prefilled pen. Tezepelumab is an anti-TSLP human monoclonal antibody that binds to human TSLP with high affinity and prevents its interaction with the heterodimeric TSLP receptor. TSLP, an epithelial cell-derived cytokine, occupies an upstream position in the asthma inflammatory cascade and plays a role in the initiation and persistence of airway inflammation in asthma.

Approved indications

— Add-on maintenance treatment in patients aged 12 years and older with severe asthma who are inadequately controlled despite optimal therapy including medium or high dose inhaled corticosteroids plus another non-steroidal medicinal product for maintenance treatment.

Dosing overview

The recommended dose is 210 mg of Tezspire by subcutaneous injection every 4 weeks. Tezspire is administered as a subcutaneous injection into the thigh or abdomen, except for the 5 cm around the navel.

Key safety warnings

In a long-term clinical study, there were more numerically serious cardiac adverse events observed in patients treated with tezepelumab compared to those treated with placebo. No causal relationship between tezepelumab and these events has been established, nor has a patient population at risk of these events been identified. Patients should be advised of signs or symptoms suggestive of a cardiac event (for example, chest pain, dyspnoea, malaise, feeling lightheaded or faint) and to seek immediate medical attention if such symptoms occur. Hypersensitivity reactions (for example, anaphylaxis, rash) may occur following administration of Tezspire. These reactions may occur within hours of administration, but in some instances have a delayed onset (that is, days). Blocking TSLP may theoretically increase the risk of serious infections. In placebo-controlled studies, no increase in serious infections was observed with tezepelumab. TSLP may be involved in the immunological response to some helminth infections. Patients with known helminth infections were excluded from participation in clinical trials. It is unknown if Tezspire may influence a patient's response against helminth infections. Tezspire should not be used to treat acute asthma exacerbations.

Contraindications

Tezspire is contraindicated in patients who have known hypersensitivity to tezepelumab or any of its excipients.

PBS listing

Information regarding PBS listing for Tezspire is not available in the provided sources.

Regulatory history

Tezspire was first registered on the ARTG on 24 March 2025, with both prefilled pen (ARTG 432812) and prefilled syringe (ARTG 427956) variants registered. This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. A PBAC submission for severe uncontrolled allergic and/or eosinophilic asthma was withdrawn in July 2022.