BeneFIX · 4.1 Therapeutic indications · 1

HOS-083392 · 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 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. There is a potential risk of thromboembolic episodes following the administration of factor IX products, see section 4.4. 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), not known (cannot be estimated from the available data). The table lists adverse reactions reported in the clinical trials of previously treated patients and identified in postmarketing use. The frequencies are based on all causality treatment emergent adverse events in pooled clinical trials with 224 subjects. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 7  System organ class Very Common Uncommon Frequency common ≥ 1/100 ≥ 1/1,000 to not known ≥ 1/10 to < 1/10 < 1/100 (cannot be estimated from

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HOS-083388 · 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 proteins.

HOS-083387 · has-indication-information · PDF-Seite 3

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

HOS-083390 · has-interaction-information · PDF-Seite 7

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

HOS-083391 · 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 breastfeeding is not available. Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated. The effect of BeneFIX on fertility has not been established.

HOS-083389 · 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. Patients can affix one of the peel-off labels found on the vial to document the batch number in their diary or for reporting any side effects. Hypersensitivity Allergic-type hypersensitivity reactions are possible with BeneFIX. The product contains traces of hamster proteins. Potentially life-threatening anaphylactic/anaphylactoid reactions have occurred with factor IX products, including BeneFIX. 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 early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, generalised urticaria, itching, tightness of the chest, bronchospasm, laryngospasm, wheezing, hypotension, blurred vision, and anaphylaxis. 5 In some cases, these reactions have progressed to severe anaphylaxis. In the case of shock, the current medical standards for treatment of shock should be observed. In case of severe allergic reactions, alternative haemostatic measures should be considered. Inhibitors Inhibitors are an uncommon event in previously treated patients (PTPs) receiving factor IX-containing products. As one PTP treated with BeneFIX developed a clinically relevant low responding inhibitor during clinical studies and experience on antigenicity with recombinant factor IX is still limited, patients treated with BeneFIX should be carefully monitored for the development of factor IX inhibitors that should be titrated in Bethesda Units 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. Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions. Patients known to have major deletion mutations of the factor IX gene sho

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