Rixubis

HOS-216727 · 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 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 reactions. 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. 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, venous thrombosis and pulmonary embolism. The use of high purity factor IX is rarely associated with such adverse reactions. Tabulated list of adverse reactions Clinical studies with RIXUBIS included 99 subjects with at least one exposure to RIXUBIS reporting in total 5 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), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Adverse Drug Reactions, from clinical trials and spontaneous reports MedDRA Standard System Organ Class Adverse reactions Frequency per Patient Immune system disorders Hypersensitivity a) Not known Nervous system disorders

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HOS-216723 · has-contraindication-information · PDF-Seite 5

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

HOS-216722 · has-indication-information · PDF-Seite 2

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). RIXUBIS is indicated in patients of all age groups. 2

HOS-216725 · has-interaction-information · PDF-Seite 6

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

HOS-216726 · has-pregnancy-information · PDF-Seite 6

Pregnancy There are no or limited amount of data from the use of Factor IX in pregnant women. Animal reproduction studies have not been conducted with factor IX. Factor IX should be used during pregnancy and breast-feeding only if clearly indicated. 6 Breast-feeding It is unknown whether Factor IX/metabolites are excreted in human milk. Fertility There is no information on the effects of factor IX on fertility.

HOS-216724 · 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 have been reported with RIXUBIS. The product contains traces of hamster proteins. If symptoms of hypersensitivity occur, patients or their caregivers 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. The risk is highest during the early phases of initial exposure to factor IX concentrates in previously untreated patients (PUPs), in particular in patients with high-risk gene mutations. There have been reports in the literature showing an association between the occurrence of a factor IX inhibitor and allergic reactions, in particular in patients with a high-risk gene mutation. Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor. In case of shock, standard medical treatment for shock should be implemented. 5 Inhibitors After repeated treatment with human coagulation factor IX (rDNA) products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing. 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 concentrates, the initial administrations 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. Nephrotic syndrome Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors. Thromboembolism Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombot

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