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NeoRecormon is a brand name for Epoetin Beta. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's EMA label. Tap a section to expand.
Therapy with NeoRecormon should be initiated by physicians experienced in the above-mentioned indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.
4 Posology Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary.
45 mmol/l). Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins. In case of intravenous administration, the solution should be injected over approx. g. in haemodialysis patients via the arteriovenous fistula at the end of dialysis.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed. 45 mmol/l). 45 mmol/l) are observed are described below. 25 mmol/l) over a four-week period should be avoided.
If it occurs, appropriate dose adjustment should be made as provided. 45 mmol/l), the dose is to be reduced by approximately 25%. If the haemoglobin level continues to increase, therapy should be interrupted until the hemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
45 mmol/l). Caution should be exercised with escalation of NeoRecormon doses in patients with chronic renal failure. 1). In the presence of hypertension or existing cardiovascular, cerebrovascular, or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture.
Treatment with NeoRecormon is divided into two stages. 1.
Correction phase - Subcutaneous administration:
The initial dosage is 3 x 20 IU/kg body weight per week. 25 g/dl per week). The weekly dose can also be divided into daily doses. - Intravenous administration: The initial dosage is 3 x 40 IU/kg per week. The dosage may be raised after 4 weeks to 80 IU/kg - three times per week - and by further increments of 20 IU/kg if needed, three times per week, at monthly intervals.
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. 4). g. 4). g. 4. 4). 4). In isolated cases, neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with NeoRecormon therapy has been reported.
4). Adverse reactions are listed in Table 1 below. 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. 4). Adverse reactions are listed in Table 3 below. 4) Tabulated list of adverse reactions Adverse reactions are listed according to MedDRA system organ class and frequency category.
Frequency categories are defined using 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); not known (cannot be estimated from the available data).
4). Description of selected adverse reactions Rarely, epoetin beta treatment-related skin reactions such as rash, pruritus, urticaria or injection site reactions may occur. In very rare cases, epoetin beta treatment-related anaphylactoid reactions have been reported.
However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found. In very rare cases, particularly when starting treatment, epoetin beta treatment-related flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported.
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.
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. 8). 8 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.
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.
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For both routes of administration, the maximum dose should not exceed 720 IU/kg per week. 2. Maintenance phase To maintain an Hb of between 10 and 12 g/dl, the dosage is initially reduced to half of the previously administered amount.
Subsequently, the dose is adjusted at intervals of one or two weeks individually for the patient (maintenance dose). 5 In the case of subcutaneous administration, the weekly dose can be given as one injection per week or in divided doses three or seven times per week.
Patients who are stable on a once weekly dosing regimen may be switched to once every two weeks administration. In this case, dose increases may be necessary. Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.
Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted. Treatment with NeoRecormon is normally a long-term therapy. It can, however, be interrupted, if necessary, at any time. Data on the once weekly dosing schedule are based on clinical studies with a treatment duration of 24 weeks.
w. per week. Premature infants who have already been transfused by the start of treatment with NeoRecormon are not likely to benefit as much as untransfused infants. The recommended treatment duration is 6 weeks. g. 21 mmol/l). Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary.
The weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week. The recommended initial dose is 30 000 IU per week (corresponding to approximately 450 IU/kg body weight per week, based on an average weighted patient).
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed. 45 mmol/l). 45 mmol/l) should be […]
These reactions were mild or moderate in nature and subsided after a couple of hours or days. Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa, reported an incidence of stroke as common. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
These increases in blood pressure can be treated with medicinal products. If blood pressure rises cannot be controlled by drug therapy, a transient interruption of NeoRecormon therapy is recommended. Particularly at the beginning of therapy, regular monitoring of the blood pressure is recommended, including between dialyses.
Hypertensive crisis with encephalopathy-like symptoms may occur and require the immediate attention of a physician and intensive medical care. Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning sign.
8). More severe cases have been observed with long-acting epoetins. At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, NeoRecormon should be withdrawn immediately and an alternative treatement considered.
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of NeoRecormon, treatment with erythropoiesis stimulating agent (ESA) must not be restarted in this patient at any time. Chronic renal failure In chronic renal failure patients, there may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with NeoRecormon, especially after intravenous administration.
This regresses during the course of continued therapy. It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy. 2. 45 mmol/l). Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
In premature infants there may be a slight rise in platelet counts, particularly up to day 12 - 14 of life, therefore platelets should be monitored regularly. 9 Effect on tumour growth Epoetins are growth factors that primarily stimulate red blood cell production.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours. In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
69 mmol/l), […]