Tezspire

1). 3 Posology Tezspire is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on the patient's level of disease control. Asthma Adults and adolescents (aged 12 years and older) The recommended dose is 210 mg of tezepelumab by subcutaneous injection every 4 weeks.

CRSwNP The recommended dose for adult patients is 210 mg of tezepelumab by subcutaneous injection every 4 weeks. Missed dose If a dose is missed, the dose should be administered as soon as possible. Thereafter, the patient can resume dosing on the scheduled day of administration.

If the next dose is already due, then administer as planned. A double dose must not be administered. 2). 2). Paediatric population The safety and efficacy of Tezspire in children under 12 years of age for the treatment of asthma have not been established.

No data are available. The safety and efficacy of Tezspire in children under 18 years of age for the treatment of CRSwNP have not been established. No data are available. Method of administration Tezspire is administered as a subcutaneous injection.

A patient may self-inject or the patient’s caregiver may administer this medicinal product after training in subcutaneous injection technique. Proper training should be provided to patients and/or caregivers on the preparation and administration of Tezspire prior to use according to the “Instructions for Use”.

Tezspire should be injected into the thigh or abdomen, except for the 5 cm around the navel. If a healthcare professional or caregiver administers the injection, the upper arm can also be used. A patient should not self-inject in the arm.

It should not be injected into areas where the skin is tender, bruised, erythematous, or hardened. It is recommended to rotate the injection site with each injection. Comprehensive instructions for administration using the pre-filled syringe or pre-filled pen is provided in the “Instructions for Use”.

4%). Tabulated list of adverse reactions Table 1 presents the adverse reactions from clinical studies in patients with severe asthma and CRSwNP who received at least one dose of Tezspire in trials of 52 weeks duration, and from post-marketing experience.

The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1 List of adverse reactions System organ class Adverse reactions Frequency Infections and infestations Pharyngitisa Common Immune system disorders Hypersensitivity (including anaphylactic reaction) Not known Skin and subcutaneous tissue disorders Rashb Common Musculoskeletal and connective tissue disorders Arthralgia Common General disorders and administration site conditions Injection site reactionc Common a Pharyngitis was defined by the following grouped preferred terms: pharyngitis, pharyngitis bacterial, pharyngitis streptococcal and viral pharyngitis.

7 b Rash was defined by the following grouped preferred terms: rash, rash pruritic, rash erythematous, rash maculo-papular, rash macular. c See ‘Description of selected adverse reactions’. g. 8% in patients treated with tezepelumab 210 mg subcutaneous every 4 weeks (Q4W).

1). The safety profile in adolescents was generally similar to the overall study population. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 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. g. 8). 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. 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.

1. 4