Idelvion · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-097379 · 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 infusion 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). In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also section 4.4). Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction. Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed. Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX. 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. One case with high-titre inhibitor was reported in the clinical study which evaluated previously untreated patients. Inhibitor development has been observed in previously treated patients in the post-marketing experience with IDELVION. There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations. The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, 7 venous thrombosis and pulmonary embolism. The use of high purity factor IX is rarely associated with such adverse reactions. Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). The table lists adverse reactions that were reported in clinical trials and/or were identified in post-marketing use. 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 seriou

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HOS-097375 · has-contraindication-information · PDF-Seite 6

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

HOS-097374 · has-indication-information · PDF-Seite 3

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). IDELVION can be used for all age groups.

HOS-097377 · has-interaction-information · PDF-Seite 7

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

HOS-097378 · has-pregnancy-information · PDF-Seite 7

Animal reproduction studies have not been conducted with factor IX. Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast- feeding is not available. Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated. There is no information on the effects of factor IX on fertility.

HOS-097376 · has-warning-information · PDF-Seite 6

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 are possible with IDELVION. 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. In case of shock, standard medical treatment for shock should be implemented. Inhibitors After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing. Formation of inhibitor to factor IX has been reported during factor replacement therapy with IDELVION in the treatment of haemophilia B. There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions. Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor. It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX. Because of the risk of allergic reactions with factor IX products, the initial administration of factor IX should, according to the treating physician’s judgement, be performed under medical observation where proper medical care for allergic reactions could be provided. Thromboembolism Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC. In each of these situations, the benefit of treatment with IDELVION should be weighed against the risk of these complications. Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk. Catheter-related complications If a central venous access device (CVAD) is r

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