Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Acute asthma exacerbations

Tezspire should not be used to treat acute asthma exacerbations.
Asthma-related symptoms or exacerbations may occur during treatment. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.

Corticosteroids

Abrupt discontinuation of corticosteroids after initiation of 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 tezepelumab (see section 4.8). These reactions may occur within hours of 

administration, but in some instances have a delayed onset (i.e. days).
A history of anaphylaxis unrelated to tezepelumab may be a risk factor for anaphylaxis following Tezspire administration. In line with clinical practice, patients should be monitored for an appropriate time after administration of Tezspire.

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.

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.

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.

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 tezepelumab may influence a patient’s response against helminth infections.

Patients with pre-existing helminth infections should be treated before initiating therapy with tezepelumab. If patients become infected while receiving treatment and do not respond to anti- helminth treatment, therapy with tezepelumab should be discontinued until infection resolves.

Sodium content

This medicinal product contains less than 1 mmol sodium (23 mg) per 210 mg dose, that is to say essentially ‘sodium-free’.




Effects on Driving

4.7 Effects on ability to drive and use machines

Tezspire has no or negligible influence on the ability to drive and use machines.