Afstyla · 4.8 Undesirable effects · 1

HOS-097601 · 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 injection site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely with the use of factor VIII products and may in some cases progress to severe anaphylaxis (including shock). Development of neutralizing antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with AFSTYLA. If such inhibitors occur, the condition may manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted. Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). The frequencies in the table below were observed in completed clinical studies in previously treated patients with severe haemophilia A. Frequencies have been evaluated on a per patient basis 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). MedDRA Adverse reaction Frequency System Organ Class uncommon (PTPs)* Blood and lymphatic FVIII inhibition very common system disorders (PUPs)* Immune system disorders Hypersensitivity common Nervous system disorders Dizziness common Paraesthesia common Skin and subcutaneous Rash common tissue disorders Erythema uncommon Pruritus uncommon General disorders and Pyrexia common administration site Injection site pain uncommon conditions Chills uncommon Feeling hot uncommon *Frequency is b

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HOS-097597 · has-contraindication-information · PDF-Seite 5

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

HOS-097596 · has-indication-information · PDF-Seite 3

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

HOS-097599 · has-interaction-information · PDF-Seite 6

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

HOS-097600 · has-pregnancy-information · PDF-Seite 6

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. 6

HOS-097598 · has-warning-information · PDF-Seite 5

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 AFSTYLA. The product contains traces of hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately 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. For patients with previous hypersensitivity reactions appropriate pre-medication may be considered. 5 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 procoagulant 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. Monitoring laboratory tests If the one-stage clotting assay is used, multiply the result by a conversion factor of 2 to determine the patient’s factor VIII activity level (see section 4.2). Card

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