Voncento · 4.8 Undesirable effects · 1

HOS-096262 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile During treatment with Voncento the following adverse reactions may occur: Hypersensitivity or allergic reactions, thromboembolic events, pyrexia, headache, dysgeusia and abnormal liver function test levels. Furthermore patients may develop inhibitors to FVIII and VWF. Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classification. 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). 8 Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA Standard System Adverse Reaction* Frequency Organ Class Blood and lymphatic system FVIII inhibition Uncommon (PTPs)** disorders Very common (PUPs)** VWF inhibition Not known*** Immune system disorders Hypersensitivity (including Common tachycardia, chest pain, chest discomfort and back pain) Nervous system disorders Dysgeusia Uncommon Vascular disorders Thromboembolic event Uncommon General disorders and Pyrexia Common administration site conditions Headache Very common Investigations Liver function test abnormal Uncommon * Adverse events assessed as related to administration of the Voncento **Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients. *** Observed during postmarketing surveillance, not observed in clinical trials. Description of selected adverse reactions Hypersensitivity (allergic reactions) 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 (including chest pain

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HOS-096258 · has-contraindication-information · PDF-Seite 6

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

HOS-096257 · has-indication-information · PDF-Seite 3

Voncento can be used for all age groups. von Willebrand disease (VWD) Prophylaxis and treatment of haemorrhage or surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Haemophilia A (congenital FVIII deficiency) Prophylaxis and treatment of bleeding in patients with haemophilia A.

HOS-096260 · has-interaction-information · PDF-Seite 7

No interaction of VWF and FVIII with other medicinal products have been studied. 7

HOS-096261 · has-pregnancy-information · PDF-Seite 8

Animal reproduction studies have not been conducted with Voncento. von Willebrand disease Experience in the treatment of pregnant or breast-feeding women is not available. Voncento should be administered to pregnant or breast-feeding VWF deficient women only if clearly indicated, taking into consideration that delivery confers an increased risk of haemorrhagic events in these patients. Haemophilia A Based on the rare occurrence of haemophilia A in women, experience regarding the treatment during pregnancy and breastfeeding is not available. Therefore, Voncento should be used during pregnancy and breast-feeding only if clearly indicated. Fertility There are no data on fertility available.

HOS-096259 · has-warning-information · PDF-Seite 6

Traceability It is strongly recommended that every time that Voncento is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product. Hypersensitivity Allergic type hypersensitivity reactions are possible. 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. In case of shock, the current medical standards for shock treatment should be observed. Virus safety 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 donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A virus (HAV). The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia). Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived factor VIII/VWF products. von Willebrand disease There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors. Therefore, patients at risk must be monitored for early signs of thrombosis. Prophylaxis against venous thromboembolism should be instituted, according to the current recommendations. When using a FVIII-containing VWF product, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII:C. In patients receiving FVIII-containing VWF products, plasma levels

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