Esperoct · 4.4 Special warnings and precautions for use · 1

HOS-098877 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock). Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed. Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Esperoct. If such inhibitors occur, the condition will manifest itself as 7 an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre is contacted. Tabulated list of adverse reactions The frequencies of adverse reactions as observed across six clinical studies in a total of 270 PTPs and 81 PUPs with severe haemophilia A (< 1% endogenous factor VIII activity) and no history of inhibitors are listed in table 3. The categories of adverse reactions presented in table 3 is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies have been evaluated according to 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); not known (cannot be estimated from the available data). Table 3 Frequency of adverse drug reactions in clinical studies System Organ Class Preferred term Frequency (PTPs) Frequency (PUPs) Blood and lymphatic Factor VIII inhibition* Uncommon Very common** system disorders Skin and subcutaneous Pruritus Common - tissue disorders Erythema Common Common Rash Common Common General disorders and Injection site reaction*** Common Common administration site conditions Immune system disorders Drug hypersen

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HOS-098873 · has-contraindication-information · PDF-Seite 6

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known allergic reaction to hamster protein.

HOS-098872 · has-indication-information · PDF-Seite 3

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Esperoct can be used for all age groups.

HOS-098875 · has-interaction-information · PDF-Seite 7

No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.

HOS-098876 · has-pregnancy-information · PDF-Seite 7

Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available. Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.

HOS-098874 · has-warning-information · PDF-Seite 6

Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity Allergic-type hypersensitivity reactions are possible with Esperoct. The product contains traces of hamster proteins, which in some patients may cause allergic reactions. If symptoms of hypersensitivity occur, patients should be advised to immediately discontinue the use of the medicinal product and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. In case of shock, standard medical treatment for shock should be implemented. Inhibitors The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII pro-coagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay. The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon. The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors. In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed. In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors. Decreased factor VIII activity in previously treated patients From post marketing reports, a decreased factor VIII activity in the absence of detectable factor VIII inhibitors has been reported in previously treated patients (PTPs). The decreased factor VIII activity was observed at time of

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