Leitlinien & Arzneimittelsicherheit

HOS-288435 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile A total of 103 patients received at least one dose of eptacog beta (activated). The overall safety population used for the integrated analysis (see Table 3) comprised 75 unique patients, in four clinical studies, exposed to 3 418 injections in a total of 1 117 treatment episodes. The most frequently reported adverse reactions were infusion site discomfort (1.3%), infusion site haematoma (1.3%), post- procedural haematoma (1.3%), infusion-related reaction (1.3%), body temperature increased (1.3%), dizziness (1.3%) and headache (1.3%). Twenty-eight (28) other patients received a single intravenous bolus dose of eptacog beta (activated) in a fifth clinical study (Study LFB-FVIIA-009-19): a summary of the safety data from study LFB-FVIIA-009-19 is presented hereafter. Paediatric population 7 Of the 75 patients included in the integrated analysis of safety, 34 were adolescents and children: 13 (17%) were aged <6 years, 15 (20%) were from 6 to less than 12 years and 6 (8%) were < 18 years. The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults. Tabulated list of adverse reactions In this section, the following categories of frequency have been used: 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 3 lists the adverse reactions. Table 3: Adverse reactions from pooled clinical studies System Organ Class Adverse Reactions (Preferred Frequency Term) Common Nervous system disorders Dizziness Common Headache General disorders and Injection site discomfort Common administration site conditions Common Injection site haematoma Common Investi

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HOS-288431 · has-contraindication-information · PDF-Seite 5

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

HOS-288430 · has-indication-information · PDF-Seite 2

2 CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: • in patients with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ≥5 Bethesda Units (BU)); • in patients with congenital haemophilia with low titre inhibitors (BU <5), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX.

HOS-288433 · has-interaction-information · PDF-Seite 7

No interaction studies have been conducted with this medicinal product. Clinical experience with pharmacologic use of other FVIIa-containing products indicates an elevated risk of thrombotic events when used simultaneously with activated prothrombin complex concentrates (see section 4.4). Based on a non-clinical study with eptacog alfa it is also not recommended to combine rFVIIa and rFXIII. There are no clinical data available on the interaction between rFVIIa and rFXIII.

HOS-288434 · has-pregnancy-information · PDF-Seite 7

Pregnancy There are no data on the use of eptacog beta (activated) in pregnant women. As a precautionary measure, it is preferable to avoid the use of this medicinal product during pregnancy. Breast-feeding It is unknown whether eptacog beta (activated) is excreted in human milk. No studies have been conducted to assess the impact of eptacog beta (activated) on milk production or its presence in breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from CEVENFACTA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility Animal studies do not indicate direct or indirect harmful effect on male fertility. No fertility data are available in humans. Thus, the effect of eptacog beta (activated) on male and female fertility is unknown.

HOS-288432 · 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. Thrombosis 5 There is limited information about the safety of this medicinal product in patients with a history of arterial or venous thromboembolic disease, because such patients were excluded from CEVENFACTA clinical studies. Such reactions have been reported in clinical studies and post-marketing surveillance with eptacog alfa and aPCC/PCC (activated or non-activated prothrombin complex). The following patients may be at an increased risk of thromboembolic events with use of this medicinal product: • History of congenital or acquired haemophilia receiving concomitant treatment with aPCC/PCC or other haemostatic agents (see section 4.5); • History of atherosclerosis, coronary artery disease, cerebrovascular disease, crush injury, septicaemia, or thromboembolism. Patients receiving this medicinal product should be monitored for the development of signs and symptoms of activation of the coagulation system or thrombosis. When there is laboratory confirmation of intravascular coagulation or presence of clinical thrombosis, the dose of this medicinal product should be reduced or treatment should be stopped, depending on the patient’s condition. Hypersensitivity reactions Hypersensitivity reactions, including anaphylaxis, may occur with this medicinal product. Symptoms may include hives, itching, rash, difficulty breathing, swelling around the mouth and throat, tightness of the chest, wheezing, dizziness or fainting, and low blood pressure. In the event of hypersensitivity reactions, patients should discontinue treatment and seek immediate medical attention. Patients with known IgE-based hypersensitivity to casein may be at a higher risk of hypersensitivity reactions. Should signs or symptoms of hypersensitivity occur, treatment should be discontinued. Subsequent treatment with this medicinal product should be based on a thorough assessment of the risks and benefits. Neutralising antibodies Neutralising antibodies may occur with the use of this medicinal product. If treatment with this medicinal product does not result in adequate haemostasis, then the development of neutralising antibodies should be suspected as the possible cause and, as clinically indicated, testing should be performed. Neutralising antibodies to o

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