Kovaltry · 4.1 Therapeutic indications · 1

HOS-216743 · has-adverse-reaction-information · PDF-Seite 6

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 and may in some cases progress to severe anaphylaxis (including shock). Development of antibodies to mouse and hamster protein with related hypersensitivity reactions may occur. Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII (FVIII), including with Kovaltry. 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). 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 6 Table 2: Frequency of adverse drug reactions in clinical trials MedDRA Adverse reactions Frequency System Organ Class Blood and lymphatic system Lymphadenopathy uncommon disorders FVIII inhibitor very common (PUPs)* uncommon (PTPs)* Immune system disorders Hypersensitivity uncommon Psychiatric disorders Insomnia common Nervous system disorders Headache common Dizziness common Dysgeusia uncommon Cardiac disorders Palpitation uncommon Sinus tachycardia uncommon Vascular disorders Flushing uncommon

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HOS-216739 · has-contraindication-information · PDF-Seite 4

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

HOS-216738 · has-indication-information · PDF-Seite 3

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

HOS-216741 · has-interaction-information · PDF-Seite 6

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

HOS-216742 · has-pregnancy-information · PDF-Seite 6

Pregnancy 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 is not available. Therefore, factor VIII should be used during pregnancy only if clearly indicated. Breast-feeding It is unknown whether Kovaltry is excreted in human milk. The excretion in animals has not been studied. Therefore, factor VIII should be used during breast-feeding only if clearly indicated. Fertility No animal fertility studies have been conducted with Kovaltry and its effect on human fertility has not been established in controlled clinical trials. Since Kovaltry is a replacement protein of endogenous factor VIII, no adverse effects on fertility are expected.

HOS-216740 · has-warning-information · PDF-Seite 4

Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 4 Hypersensitivity Allergic type hypersensitivity reactions are possible with Kovaltry. If symptoms of hypersensitivity occur, patients should be advised to discontinue the 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, 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 (see section 4.2). 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. Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk. Catheter-related complications If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and cath

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