ABSEAMED

Treatment with Abseamed has to be initiated under the supervision of physicians experienced in the management of patients with the above indications. Posology All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.

4). Treatment of symptomatic anaemia in adult chronic renal failure patients Anaemia symptoms and sequelae may vary with age, gender, and co-morbid medical conditions; a physician’s evaluation of the individual patient’s clinical course and condition is necessary.

5 mmol/L). 5 mmol/L). 25 mmol/L) over a four week period should be avoided. If it occurs, appropriate dose adjustment should be made as provided. Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin concentration range may be observed.

5 mmol/L). 5 mmol/L) should be avoided. 5 mmol/L) reduce the Abseamed dose by 25%. 5 mmol/L) and then reinstitute Abseamed therapy at a dose 25% below the previous dose. 5 mmol/L). Caution should be exercised with escalation of erythropoiesis-stimulating agent (ESA)doses in patients with CRF.

1). Treatment with Abseamed is divided into two stages – correction and maintenance phase. Adult haemodialysis patients In patients on haemodialysis where intravenous access is readily available, administration by the intravenous route is preferable.

Correction phase The starting dose is 50 IU/kg, 3 times per week. 5 mmol/L) is achieved (this should be done in steps of at least four weeks). Maintenance phase The recommended total weekly dose is between 75 IU/kg and 300 IU/kg. 5 mmol/L).

75 mmol/L) may require higher maintenance doses than patients whose initial anaemia is less severe (> 8 g/dL or > 5 mmol/L). Adult patients with renal insufficiency not yet undergoing dialysis Where intravenous access is not readily available Abseamed may be administered subcutaneously.

Correction phase Starting dose of 50 IU/kg, 3 times per week, followed if necessary by a dosage increase with 25 IU/kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).

Summary of the safety profile The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension. 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.

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). 4). 4). 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.

Traceability 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.

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. 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. 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.

1. 4). - Uncontrolled hypertension. - All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Abseamed. 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.