Tezspire Special Precautions

General: TEZSPIRE should not be used to treat acute asthma exacerbations.
Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Abrupt discontinuation of corticosteroids after initiation of TEZSPIRE therapy is not recommended. Reduction in corticosteroid doses, if appropriate, should be gradual and performed under the supervision of a physician.
Hypersensitivity reactions: Hypersensitivity reactions (e.g. anaphylaxis, rash) may occur following administration of TEZSPIRE (see Adverse Reactions). These reactions may occur within hours of administration, but in some instances have a delayed onset (i.e. days).
In the event of a hypersensitivity reaction, appropriate treatment as clinically indicated should be initiated.
Parasitic (Helminth) Infection: 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.
Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving treatment with TEZSPIRE and do not respond to anti-helminth treatment, discontinue treatment with TEZSPIRE until infection resolves.
Serious cardiac events: In a long-term clinical study, a numerical imbalance in serious cardiac adverse events was observed in patients treated with tezepelumab compared to 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. If patients develop a serious cardiac event while receiving tezepelumab treatment, therapy with tezepelumab should be discontinued until the acute event stabilises.
There is currently no data on re-treatment of patients who develop a serious cardiac event or serious infection.
Serious infections: Blocking thymic stromal lymphopoietin (TSLP) may theoretically increase the risk of serious infections. In placebo-controlled studies, no increase in serious infections was observed with tezepelumab.
Patients with pre-existing serious infections should be treated before initiating therapy with tezepelumab. If patients develop a serious infection while receiving tezepelumab treatment, therapy with tezepelumab should be discontinued until the serious infection resolves.
Effects on ability to drive and use machines: TEZSPIRE has no or negligible influence on the ability to drive and use machines.