Tezspire · 4.8 Undesirable effects · 1

HOS-099825 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most commonly reported adverse reactions during treatment for asthma are arthralgia (3.8%) and pharyngitis (4.1%) and during treatment for CRSwNP is pharyngitis (5.4%). 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 a Infections and infestations Pharyngitis Common Immune system disorders Hypersensitivity Not known (including anaphylactic reaction) Skin and subcutaneous tissue disorders Rashb Common Musculoskeletal and connective tissue disorders Arthralgia Common c General disorders and administration site Injection site reaction Common conditions a Pharyngitis was defined by the following grouped preferred terms: pharyngitis, pharyngitis bacterial, pharyngitis streptococcal and viral pharyngitis. 6 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’. Description of selected adverse reactions Injection site reactions In the pooled safety data from PATHWAY and NAVIGATOR, injection site reactions (e.g. injection site erythema, injection site swelling, injection site pain) occurred at a rate of 3.8% in patients treated with tezepelumab 210 mg subc

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HOS-099821 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 3

HOS-099820 · has-indication-information · PDF-Seite 2

Asthma Tezspire is indicated as an 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. Chronic rhinosinusitis with nasal polyps (CRSwNP) Tezspire is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control.

HOS-099823 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. The use of live attenuated vaccines should be avoided in patients receiving tezepelumab. In a randomised, double blind, parallel group study of 70 patients aged between 12 and 21 years with moderate to severe asthma, tezepelumab treatment did not appear to affect the humoral antibody responses induced by seasonal quadrivalent influenza vaccination. A clinically relevant effect of tezepelumab on the pharmacokinetics of co-administered asthma medicinal products is not expected. Based on the population pharmacokinetic analysis, commonly co-administered asthma medicinal products (including leukotriene receptor antagonists, theophylline/aminophylline and oral corticosteroids) had no effect on tezepelumab clearance.

HOS-099824 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tezepelumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Human IgG antibodies, such as tezepelumab, are transported across the placenta barrier; therefore, Tezspire may be transmitted from the mother to the developing foetus. As a precautionary measure, it is preferable to avoid the use of Tezspire during pregnancy unless the expected benefit to the pregnant mother is greater than any possible risk to the foetus. 5 Breast-feeding It is unknown whether tezepelumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period. For this specific period, a decision should be made whether to discontinue/abstain from tezepelumab therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman. Afterwards, tezepelumab could be used during breast-feeding if clinically needed. See section 5.3 for information on the excretion of tezepelumab in animal (cynomolgus monkey) milk. Fertility There are no fertility data in humans. Animal studies showed no adverse effects of tezepelumab treatment on fertility (see section 5.3).

HOS-099822 · has-warning-information · PDF-Seite 4

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. 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 eve

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