Leitlinien & Arzneimittelsicherheit

HOS-097829 · has-adverse-reaction-information · PDF-Seite 24

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 and may in some cases progress to severe anaphylaxis (including shock). Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ADYNOVI. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted (see section 5.1). Tabulated list of adverse reactions The safety of ADYNOVI was evaluated in 478 unique patients with severe haemophilia A (factor VIII less than 1% of normal), of which 360 were previously-treated patients (PTPs) and 118 were previously-untreated patients (PUPs), who received at least one dose of ADYNOVI in 7 completed multi-centre, prospective, open label clinical trials. The table presented below is according to the MedDRA system organ classification (System Organ Class 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 24 Table 2: Adverse reactions reported for ADYNOVI MedDRA Adverse reactions Frequency Standard system organ class Blood and lymphatic system disorders Factor VIII inhibition Uncommon (PTPs)1 Very common (PUPs)1 Immune system disorders Hypersensitivity Uncommon Anaphylactic reaction2 Not known Nervous system disorders Headache Common Dizziness Common Eye disorders Ocular hyperaemia Uncommon Vascular disorders

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HOS-097823 · 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 injection 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). Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ADYNOVI. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted (see section 5.1). Tabulated list of adverse reactions The safety of ADYNOVI was evaluated in 478 unique patients with severe haemophilia A (factor VIII less than 1% of normal), of which 360 were previously-treated patients (PTPs) and 118 were 6 previously-untreated patients (PUPs), who received at least one dose of ADYNOVI in 7 completed multi-centre, prospective, open label clinical trials. The table presented below is according to the MedDRA system organ classification (System Organ Class 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 2: Adverse reactions reported for ADYNOVI MedDRA Adverse reactions Frequency Standard system organ class Blood and lymphatic system disorders Factor VIII inhibition Uncommon (PTPs)1 Very common (PUPs)1 Immune system disorders Hypersensitivity Uncommon Anaphylactic reaction2 Not known Nervous system disorders Headache Common Dizziness Common Eye disorders Ocular hyperaemia Uncommon Vascular disorders Flushing

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HOS-097819 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients listed in section 6.1. Known allergic reaction to mouse or hamster protein.

HOS-097825 · has-contraindication-information · PDF-Seite 22

Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients listed in section 6.1. Known allergic reaction to mouse or hamster protein.

HOS-097824 · has-indication-information · PDF-Seite 20

Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency). 20

HOS-097818 · has-indication-information · PDF-Seite 3

Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).

HOS-097821 · has-interaction-information · PDF-Seite 6

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

HOS-097827 · has-interaction-information · PDF-Seite 24

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

HOS-097822 · 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.

HOS-097828 · has-pregnancy-information · PDF-Seite 24

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-097826 · has-warning-information · PDF-Seite 22

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. 22 Hypersensitivity Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with ADYNOVI. The medicinal product contains traces of mouse and 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. 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 (EDs) 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. Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk. Catheter-related complications in treatment If a central venous access device

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HOS-097820 · has-warning-information · PDF-Seite 5

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 Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with ADYNOVI. The medicinal product contains traces of mouse and 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. 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 (EDs) 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. Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk. Catheter-related complications in treatment If a central venous access device (CVAD) is required, risk of CVAD-related complications

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