epoetin beta

HOS-083255 · has-adverse-reaction-information · PDF-Seite 11

Summary of the safety profile Based on results from clinical trials including 1 725 patients, approximately 8% of patients treated with NeoRecormon are expected to experience adverse reactions. Anaemic patients with chronic renal failure The most frequent adverse reaction during treatment with NeoRecormon is an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase (see section 4.4). Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4). Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurisms), see section 4.4. In most cases, a fall in serum ferritin values simultaneous with a rise in packed cell volume is observed (see section 4.4). In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases (see section 4.4). In isolated cases, neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with NeoRecormon therapy has been reported. In case anti-erythropoietin antibody-mediated PRCA is diagnosed, therapy with NeoRecormon must be discontinued and patients should not be switched to another erythropoietic protein (see section 4.4). Adverse reactions are listed in Table 1 below. Patients with cancer Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (see section 4.4). In some patients, a fall in serum iron parameters is observed (see section 4.4). Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated with NeoRecormon compared to untreated controls or placebo. In patients treated with NeoRecormon, this incidence is 7% compared to 4% in controls; this is not associated with any increase in thromboembolic mortality compared with controls. Adverse reactions are listed in Table 2 below. Patients in an autologous blood pre-donation programme Patients in an autologous blood pre-donation programme have been reported to show a slightly higher frequency of thromboembolic events. However, a causal relationship with treatment with NeoRecormon could not be established. In placebo-controlled trials, tem

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HOS-083251 · has-contraindication-information · PDF-Seite 7

Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Poorly controlled hypertension. In the indication “increasing the yield of autologous blood”: myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.

HOS-083250 · has-indication-information · PDF-Seite 3

NeoRecormon is indicated for: - Treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric patients. - Prevention of anaemia of prematurity in infants with a birth weight of 750 to 1 500 g and a gestational age of less than 34 weeks. - Treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy. - Increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving 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). See section 5.1

HOS-083253 · has-interaction-information · PDF-Seite 10

The clinical results obtained so far do not indicate any interaction of NeoRecormon with other medicinal products. Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.

HOS-083254 · has-pregnancy-information · PDF-Seite 10

Pregnancy For epoetin beta no clinical data on exposed pregnancies are available. Caution should be exercised when prescribing to pregnant women. Breast-feeding It is unknown whether epoetin beta is excreted in human milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with epoetin beta should be made taking into account the benefit of breast-feeding to the child and the benefit of epoetin beta therapy to the woman. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).

HOS-083252 · has-warning-information · PDF-Seite 7

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. NeoRecormon should be used with caution in the presence of refractory anaemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure. Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of NeoRecormon. Caution should be exercised with escalation of NeoRecormon doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events. In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and 5.1). In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment, and supplementary iron therapy may be necessary and conducted in accordance with therapeutic guidelines. Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of NeoRecormon. The indication for treatment with NeoRecormon of nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty. Pure red cell aplasia (PRCA) PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including NeoRecormon. These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to NeoRecormon (see section 4.8). 7 PRCA in patients with Hepatitis C A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing. Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly. Epoetins are not approved in the management of anaemia associated with hepatitis C. Blood pressure monitoring An increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase can occur. These

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