Binocrit is Epoetin Alfa, belonging to the category of Anti-anaemic, erythropoietin.
Binocrit 8.000 UI - Epoetin Alfa
Binocrit is a Epoetin Alfa, belonging to the category of Anti-anaemic, erythropoietin.
Binocrit therapy should be initiated under the supervision of physicians experienced in the treatment of patients with the indications listed above.
All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium poisoning, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated before initiation of Epoetin Alfa therapy and when deciding on a dose increase. To ensure optimal response to Epoetin Alfa, adequate iron stores should be ensured and iron supplements administered if necessary.
Treatment of symptomatic anaemia in adult patients with chronic renal failure
The symptoms and consequences of anaemia may vary according to age, sex and medical comorbidities; individual assessment of each patient's clinical course and condition by the physician is required.
The recommended range of haemoglobin concentration is between 10 g/dl and 12 g/dl (between 6.2 and 7.5 mmol/L). Binocrit should be administered so that haemoglobin values do not increase above 12 g/dL (7.5 mmol/L). An increase in haemoglobin greater than 2 g/dL (1.25 mmol/L) over a period of weeks should be avoided. If this occurs, an appropriate dose adjustment should be made.
Due to intra-patient variability, individual haemoglobin values above and below the desired range of haemoglobin concentration may occasionally be observed. Haemoglobin variability should be addressed by dose adjustment, taking into account the haemoglobin concentration range of 10 g/dL (6.2 mmol/L) to 12 g/dL (7.5 mmol/L).
Prolonged haemoglobin levels above 12 g/dL (7.5 mmol/L) should be avoided. If hemoglobin increases by more than 2 g/dL (1.25 mmol/L) per month, or if prolonged hemoglobin levels exceed 12 g/dL (7.5 mmol/L), reduce the Binocrit dose by 25%. If haemoglobin exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until values fall below 12 g/dL (7.5 mmol/L) and then resume Binocrit treatment at a dose 25% lower than the previous dose.
Patients should be carefully monitored to ensure that the lowest approved effective dose of Binocrit is used for adequate control of anaemic symptoms while maintaining a haemoglobin concentration of less than or equal to 12 g/dL (7.45 mmol/L).
Use caution when increasing Binocrit doses in patients with chronic renal failure. In patients with a poor haemoglobin response to Binocrit, alternative explanations for the poor response should be considered.
Treatment with Binocrit consists of two phases: the correction phase and the maintenance phase.
Adult patients on haemodialysis
In haemodialysis patients where intravenous access is readily available, intravenous administration is preferred.
The starting dose is 50 IU/kg, three times weekly.
If necessary, increase or decrease the dose by 25 IU/kg (three times weekly) until the desired range of haemoglobin concentration between 10 g/dL and 12 g/dL (between 6.2 and 7.5 mmol/L) is achieved (this should be done gradually at intervals of at least four weeks).
The total recommended weekly dose is between 75 IU/kg and 300 IU/kg.
Appropriate dose adjustment should be made to maintain haemoglobin values within the desired concentration range of 10 g/dL to 12 g/dL (between 6.2 and 7.5 mmol/L).
Patients with very low initial haemoglobin values (< 6 g/dL or < 3.75 mmol/L) may require higher maintenance doses than patients with less severe initial anaemia (> 8 g/dL or > 5 mmol/L).
Adult patients with renal failure who have not yet been dialysed
When intravenous access is not readily available, binocrit may be administered subcutaneously.
Initial dose of 50 IU/kg, 3 times weekly, followed, if necessary, by increments of 25 IU/kg (3 times weekly) until the desired value is achieved (this should be done gradually at intervals of at least four weeks).