Fasenra · 4.3 Contraindications · 1

HOS-098289 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The safety profile of benralizumab in asthma, EGPA and HES are similar. The most commonly reported adverse reactions during treatment in asthma are headache (8%) and pharyngitis (3%). The most commonly reported adverse reaction in EGPA (17%) and HES (16%) is headache. Cases of anaphylactic reaction of varied severity have been reported for benralizumab. Tabulated list of adverse reactions The following adverse reactions have been reported with benralizumab during clinical studies in asthma, EGPA and HES, 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. Tabulated list of adverse reactions MedDRA System organ class Adverse reaction Frequency Infections and infestations Pharyngitisa Common Immune system disorders Hypersensitivity reactionsb Common Anaphylactic reaction Not known Nervous system disorders Headachec Common General disorders and Pyrexia Common administration site conditions Injection site reactiond a. Pharyngitis including: ‘Pharyngitis’, ‘Pharyngitis bacterial’, ‘Viral pharyngitis’, ‘Pharyngitis streptococcal’. b. Hypersensitivity reactions including: ‘Urticaria’, ‘Papular urticaria’, and ‘Rash’. For examples of the associated manifestations reported and a description of the time to onset, see section 4.4. c. Very common in EGPA and HES clinical studies. d. See ‘Description of selected adverse reactions’. Description of selected adverse reactions Injection site reactions In placebo-controlled asthma studies, injection site reactions (e.g. pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with the recommended benralizumab dose compared with 1.9% in patients treated with placebo. The events were transient in nature. 6 Long-term safety In a 56-week extension trial (Trial 4) in p

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098285 · has-contraindication-information · PDF-Seite 4

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

HOS-098284 · has-indication-information · PDF-Seite 2

Asthma Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists (see section 5.1). Eosinophilic granulomatosis with polyangiitis (EGPA) Fasenra is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (see section 5.1). Hypereosinophilic syndrome (HES) Fasenra is indicated as an add-on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause (see section 4.2 and 5.1).

HOS-098287 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. In a randomised, double-blind parallel-group study of 103 patients aged between 12 and 21 years with severe asthma, the humoral antibody responses induced by seasonal influenza virus vaccination do not appear to be affected by benralizumab treatment. An effect of benralizumab on the pharmacokinetics of co-administered medicinal products is not expected (see section 5.2). Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of benralizumab. There is no evidence of IL-5Rα expression on hepatocytes. Eosinophil depletion does not result in chronic systemic alterations of proinflammatory cytokines.

HOS-098288 · has-pregnancy-information · PDF-Seite 5

Pregnancy There is a limited amount of data (less than 300 pregnancy outcomes) from the use of benralizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Monoclonal antibodies, such as benralizumab, are transported across the placenta linearly as pregnancy progresses; therefore, potential exposure to the foetus is likely to be greater during the second and third trimester of pregnancy. As a precautionary measure, it is preferable to avoid the use of Fasenra during pregnancy. Its administration to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. Breast-feeding It is unknown whether benralizumab or its metabolites are excreted in human or animal milk. A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from using Fasenra taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 5 Fertility There are no fertility data in humans. Animal studies showed no adverse effects of benralizumab treatment on fertility (see section 5.3).

HOS-098286 · 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. Asthma exacerbations Fasenra 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. Corticosteroids Abrupt discontinuation of corticosteroids after initiation of Fasenra therapy is not recommended. Reduction in corticosteroid doses, if appropriate, should be gradual and performed under the supervision of a physician. Hypersensitivity reactions Acute systemic reactions including anaphylactic reactions and hypersensitivity reactions (e.g. urticaria, papular urticaria, rash) have occurred following administration of benralizumab (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 benralizumab may be a risk factor for anaphylaxis following Fasenra administration (see section 4.3). In line with clinical practice, patients should be monitored for an appropriate time after administration of Fasenra. In the event of a hypersensitivity reaction, Fasenra should be discontinued permanently and appropriate therapy should be initiated. Parasitic (Helminth) infections Eosinophils 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 benralizumab may influence a patient’s response against helminth infections. 4 Patients with pre-existing helminth infections should be treated before initiating therapy with benralizumab. If patients become infected, while receiving treatment and do not respond to anti-helminth treatment, therapy with benralizumab should be discontinued until infection resolves. Organ threatening or life-threatening EGPA Fasenra has not been studied in patients with active organ threatening or life-threatening manifestations of EGPA (see section 4.2). Life-threatening HES Fasenra has not been studied in patients with active life-threatening manifestations of HES (see section 4.2). Excipient with known effect This medicinal product contains 0.06 mg of polysorbate 20 in each 30 mg dose (1 mL). Polysorbates may cause allergic reactions.