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

HOS-097761 · 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 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 reaction. 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, 6 venous thrombosis and pulmonary embolism. The use of high purity factor IX is rarely associated with thromboembolic complications. Tabulated list of adverse reactions Previously Treated Patients (PTPs): A total of 153 patients with severe haemophilia B were observed in phase III clinical studies and an extension study. Adverse events were monitored for a total of 561 subject-years. The total number of exposure days was 26,106 with a median of 165 (range 1 to 528) exposure days per subject. Previously Untreated Patients (PUPs): A total of 33 patients with severe haemophilia B were observed in one clinical study. Adverse events were monitored for a total of 57.51 subject-years. The total number of exposure days was 2,233 with a median of 76 (range 1 to 137) exposure days per subject. Table 2 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)

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HOS-097757 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-097756 · has-indication-information · PDF-Seite 3

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

HOS-097759 · has-interaction-information · PDF-Seite 6

No interactions of ALPROLIX with other medicinal products have been reported. No interaction studies have been performed.

HOS-097760 · has-pregnancy-information · PDF-Seite 6

Pregnancy and breast-feeding Animal reproduction studies have not been conducted with ALPROLIX. A placental transfer study in mice was conducted (see section 5.3). 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 breast-feeding only if clearly indicated. Fertility There are no fertility data available. No fertility studies have been conducted in animals with ALPROLIX.

HOS-097758 · has-warning-information · PDF-Seite 5

Traceability In order to improve 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 ALPROLIX. 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 anaphylactic 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. 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 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. Thromboembolism Because of the potential risk of thrombotic complications with factor IX products, 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 disseminated intravascular coagulation (DIC). The benefit of treatment with ALPROLIX in these situations should be weighed against the risk of these complications. Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with factor IX products may increase the cardiovascular risk. 5 Catheter-related complications If a central venous access device (CVAD) is required, risk of CVAD-related complica

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