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

HOS-094584 · has-adverse-reaction-information · PDF-Seite 15

Summary of the safety profile 15 The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension. Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4). The most frequently occurring adverse drug reactions observed in clinical studies of epoetin alfa are diarrhoea, nausea, vomiting, pyrexia and headache. Influenza-like illness may occur especially at the start of treatment. Respiratory tract congestion, which includes events of upper respiratory tract congestion, nasal congestion and nasopharyngitis, have been reported in studies with extended interval dosing in adult patients with renal insufficiency not yet undergoing dialysis. An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.4). Tabulated list of adverse reactions Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects. Included were 228 epoetin alfa-treated CRF subjects in 4 CRF studies (2 studies in pre-dialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]); 1 404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies. Adverse drug reactions reported by ≥ 1% of subjects treated with epoetin alfa in these studies are shown in the table below. Frequency estimate: 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). MedDRA System Organ Adverse Reaction (Preferred Frequency Classification (SOC) Term Level) Blood and lymphatic system Pure red cell aplasia3, Rare disorders Thrombocythaemia Metabolism and nutrition Hyperkalaemia1 Uncommon disorders 3

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HOS-094580 · has-contraindication-information · PDF-Seite 10

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Abseamed or any other erythropoietin (see section 4.4). - Uncontrolled hypertension. - All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Abseamed. 10 The use of Abseamed in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident. - Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.

HOS-094579 · has-indication-information · PDF-Seite 3

Abseamed is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF): - in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis (see section 4.4). - in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients (see section 4.4). Abseamed is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements. 3 Abseamed is indicated in adults in a predonation programme to increase the yield of autologous blood. Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dL [6.2 to 8.1 mmol/L], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). Abseamed is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dL or 6.2 to 8.1 mmol/L) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 mL). Abseamed is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤ 10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/mL).

HOS-094582 · has-interaction-information · PDF-Seite 15

No evidence exists that indicates that treatment with epoetin alfa alters the metabolism of other medicinal products. Medicinal products that decrease erythropoiesis may decrease the response to epoetin alfa. Since cyclosporin is bound by RBCs there is potential for a medicinal product interaction. If epoetin alfa is given concomitantly with cyclosporin, blood levels of cyclosporin should be monitored and the dose of cyclosporin adjusted as the haematocrit rises. No evidence exists that indicates an interaction between epoetin alfa and granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor (GM-CSF) with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro. In female adult patients with metastatic breast cancer, subcutaneous co-administration of 40 000 IU/mL epoetin alfa with trastuzumab 6 mg/kg had no effect on the pharmacokinetics of trastuzumab.

HOS-094583 · has-pregnancy-information · PDF-Seite 15

Pregnancy There are no or limited amount of data from the use of epoetin alfa in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Consequently, epoetin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus. The use of epoetin alfa is not recommended in pregnant surgical patients participating in an autologous blood predonation programme. Breast-feeding It is unknown whether exogenous epoetin alfa is excreted in human milk. A risk to the newborns/infants cannot be excluded. Epoetin alfa should be used with caution in nursing women. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy with epoetin alfa taking into account the benefit of breast-feeding for the child and the benefit of epoetin alfa therapy for the woman. The use of epoetin alfa is not recommended in lactating surgical patients participating in an autologous blood predonation programme. Fertility There are no studies assessing the potential effect of epoetin alfa on male or female fertility.

HOS-094581 · has-warning-information · PDF-Seite 11

Traceablility In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name and the batch number of the administered ESA should be clearly recorded (or stated) in the patient file. Patients should only be switched from one ESA to another under appropriate supervision. General In all patients receiving epoetin alfa, blood pressure should be closely monitored and controlled as necessary. Epoetin alfa should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension. It may be necessary to add or increase anti-hypertensive treatment. If blood pressure cannot be controlled, epoetin alfa treatment should be discontinued. Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have occurred also during epoetin alfa treatment in patients with previously normal or low blood pressure. Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal (see section 4.8). Epoetin alfa should be used with caution in patients with epilepsy, history of seizures, or medical conditions associated with a predisposition to seizure activity such as CNS infections and brain metastases. Epoetin alfa should be used with caution in patients with chronic liver failure. The safety of epoetin alfa has not been established in patients with hepatic dysfunction. An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.8). These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction. Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported. The reported risk of these TVEs should be carefully weighed against the benefits to be derived from treatment with epoetin alfa particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs (e.g. deep venous thrombosis, pulmonary embolism, and cerebral vascular accident). In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the concentration range for the indication of use. There m

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