Veyvondi · 4.6 Fertility, pregnancy and lactation · 1

HOS-098351 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile During treatment with VEYVONDI the following adverse reactions may occur: hypersensitivity or allergic reactions, thromboembolic events, inhibitor formation against VWF. 7 Tabulated list of adverse reactions Table 4 lists the adverse reactions reported in clinical trials, post-authorisation safety studies or post- marketing reporting. Frequency categories are defined 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). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 4. Summary of adverse reactions reported in clinical trials, post-authorisation safety studies or post-marketing with VEYVONDI in von Willebrand disease MedDRA system organ Frequency category Adverse reaction by preferred term (PT) class (SOC) by subject Immune system disorders Anaphylactic reaction* Not known Headache Very common Dizziness Common Nervous system disorders Vertigo Common Dysgeusia Uncommon Tremor Uncommon Cardiac disorders Tachycardia Uncommon Hypertension Common Vascular disorders Deep venous thrombosis Uncommon Hot flush Uncommon Vomiting Common Gastrointestinal disorders Nausea Common Skin and subcutaneous Pruritus generalised Common tissue disorders

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HOS-098347 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 5 Known allergic reaction to mouse or hamster proteins.

HOS-098346 · has-indication-information · PDF-Seite 2

Prevention and treatment of haemorrhage or surgical bleeding in adults (aged 18 years and older) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. 2 Treatment of haemorrhage in children (aged less than 18 years) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. VEYVONDI should not be used in the treatment of haemophilia A.

HOS-098349 · has-interaction-information · PDF-Seite 7

No interactions of human von Willebrand factor products with other medicinal products are known.

HOS-098350 · has-pregnancy-information · PDF-Seite 7

Animal reproduction studies have not been conducted with VEYVONDI. Pregnancy Experience in the treatment of pregnant or breast-feeding women is not available. VEYVONDI should be administered to pregnant women only if clearly indicated, taking into consideration that delivery confers an increased risk of haemorrhagic events in these patients. Breast-feeding It is unknown whether VEYVONDI is excreted in human milk. Therefore, VEYVONDI should be administered to lactating von Willebrand factor deficient women only if clearly indicated. Healthcare professionals should balance the potential risks and only prescribe VEYVONDI if needed. Fertility The effects of VEYVONDI on fertility have not been established.

HOS-098348 · has-warning-information · PDF-Seite 6

In actively bleeding patients it is recommended to co-administer a FVIII product with VEYVONDI as a first line treatment and depending on the FVIII activity levels (see section 4.2). 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. Hypersensitivity reactions Hypersensitivity reactions (including anaphylaxis) have occurred. Patients and/or their caregivers should be informed of the early signs of hypersensitivity reactions, which may include but are not limited to tachycardia, tightness of the chest, wheezing and/or acute respiratory distress, hypotension, generalised urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, vomiting, paresthesia, restlessness, and may progress to anaphylactic shock. In case of shock, standard medical treatment for shock should be implemented. Patients should be closely monitored and carefully observed for any symptoms throughout the infusion period. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of VEYVONDI and provide appropriate supportive care. Adequate medical treatment and provisions should be available for immediate use for a potential anaphylactic reaction, especially for patients with a history of allergic reactions. VEYVONDI contains trace amounts of mouse immunoglobulin G and hamster proteins (less than or equal to 2 ng/IU VEYVONDI). Patients treated with this product may develop hypersensitivity reactions to these non-human mammalian proteins. VEYVONDI contains trace amounts of recombinant coagulation factor VIII. Thrombosis and embolism There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors for thrombosis including low ADAMTS13 levels. Therefore, patients at risk have to be monitored for early signs of thrombosis, and prophylaxis measures against thromboembolism should be instituted according to current recommendations and standard of care. In patients requiring frequent doses of VEYVONDI in combination with recombinant factor VIII, plasma level for FVIII:C activity should be monitored to avoid sustained excessive FVIII:C plasma level, which may increase the risk of thrombotic events. Any FVIII that would be administered along with VEYVONDI should be a pure FVIII product. A combination with a FVIII product containing VWF would pose an additional risk

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