Respreeza

HOS-096680 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Hypersensitivity or allergic reactions have been observed during the treatment. In the most serious cases, allergic reactions may progress to severe anaphylactic reactions even when the patient has shown no hypersensitivity to previous administrations (see section 4.4). For safety information with respect to transmissible agents, see section 4.4. Tabulated list of adverse reactions The adverse reactions (ARs) collected from six clinical studies in 221 patients and post-marketing experience are presented in the table below according to the MedDRA system organ classification (SOC and Preferred Term (PT) Level). Frequency per patient (based on six months of exposure during clinical trials) has been evaluated according to the following convention: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). The frequency of ARs during post marketing only is considered as “not known (cannot be estimated from the available data)”. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 5 Frequency of adverse reactions (ARs) in clinical studies and post-marketing experience with Respreeza System organ class Frequency of ARs (SOC) Common Uncommon Very rare (≥1/100 to (≥1/1,000 to Not known (<1/10,000) <1/10) <1/100) Blood and lymphatic system Lymph node disorders pain Immune system disorders Hypersensitivity Anaphylactic reactions reactions (including tachycardia, hypotension, confusion, syncope, oxygen

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HOS-096676 · has-contraindication-information · PDF-Seite 3

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4). • IgA deficient patients with known antibodies against IgA, due to the risk of severe hypersensitivity and anaphylactic reactions.

HOS-096675 · has-indication-information · PDF-Seite 2

Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ). Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second 2 (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.

HOS-096678 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed.

HOS-096679 · has-pregnancy-information · PDF-Seite 5

Pregnancy No animal reproduction studies have been conducted with Respreeza and its safety for use in human pregnancy has not been established in controlled clinical trials. Since alpha1-proteinase inhibitor is an endogenous human protein, it is considered unlikely that Respreeza will cause harm to the foetus when given at recommended doses. However, Respreeza should be given with caution to pregnant women. Breast-feeding It is unknown whether Respreeza / metabolites are excreted in human milk. The excretion of human alpha1-proteinase inhibitor in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Respreeza should be made, taking into account the benefit of breast-feeding to the child and the benefit of human alpha1- proteinase inhibitor therapy to the woman. Fertility No animal fertility studies have been conducted with Respreeza and its effect on human fertility has not been established in controlled clinical trials. Since human alpha1-proteinase inhibitor is an endogenous human protein, no adverse effects on fertility are expected when given at recommended doses.

HOS-096677 · has-warning-information · PDF-Seite 3

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. The recommended infusion rate given under section 4.2 should be adhered to. During the first infusions, patient’s clinical state, including vital signs, should be closely monitored throughout the infusion period. If any reaction takes place that might be related to the administration of Respreeza, the rate of infusion should be decreased or the administration should be stopped, as required by the clinical condition of the patient. If symptoms subside promptly after stopping, the infusion may be resumed at a lower rate that is comfortable for the patient. 3 Hypersensitivity Hypersensitivity reactions may occur, including in patients who have tolerated previous treatment with human alpha1-proteinase inhibitor. Respreeza may contain trace amounts of IgA. Patients with selective or severe IgA deficiency can develop antibodies to IgA and, therefore, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Suspected allergic or anaphylactic type reactions may require immediate discontinuation of the infusion, depending on the nature and severity of the reaction. In case of shock, emergency medical treatment should be administered. Home-treatment / self-administration There are limited data regarding the use of this medicinal product in home-treatment / self- administration. Potential risks associated with home-treatment / self-administration are related to the handling and administration of the medicinal product as well as to the handling of adverse reactions, particularly hypersensitivity. Patients should be informed of signs of hypersensitivity reactions. The decision of whether a patient is suitable for home-treatment / self-administration is made by the treating doctor, who should ensure appropriate training is provided (e.g. regarding reconstitution, use of Mix2Vial® set, assembly of intravenous tubing, infusion techniques, maintenance of a treatment diary, identification of adverse reactions and measures to be taken in case such reactions occur) and the use is reviewed at regular intervals. Transmissible agents Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donati

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