RECORMON
EPOETIN BETA · by ROCHE
Composition
Inj 1000 IU/2000 IU/5000 IU/6000 IU/10000 IU/20000 IU/30000 IU: Epoetin beta 1000 IU/2000 IU/5000 IU/6000 IU/10000 IU/20000 IU/30000 IU; powder in vials plus Water for injection in amp or preparation
Indications & Dosage
Symptomatic anaemia associated with chronic renal failure: BY SC INJ: Adult: Initially 20 units/kg 3 times a week for 4 weeks, increased in steps of 20 units/kg 3 times a week, according to response at intervals of 4 weeks, total weekly dose may be divided into daily doses; maintenance dose, initially reduce dose by half then adjust according to response at intervals of 1-2 weeks, total weekly maintenance dose may be given as a single dose or in 3 or 7 divided doses. Reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100ml over 4 weeks or if haemoglobin concentration approaches or exceeds 12 g/100 ml; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose; max. 720 units/kg per week BY IV INJ: Adult: Initially 40 units/kg 3 times a week for 4 weeks,then increased to 80 units/kg 3 times a week, then increased in steps of 20 units/kg 3 times a week if required, at intervals of 4 weeks; maintenance dose, initially reduce dose by half then adjust according to response at intervals of 1-2 weeks. Intravenous injection to be administered over 2 minutes, subcutaneous route preferred in patients not on haemodialysis. Reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100ml over 4 weeks or if haemoglobin concentration approaches or exceeds 12 g/100 ml; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose; max. 720 units/kg per week Symptomatic anaemia in adults with non-myeloid malignancies receiving chemotherapy: BY SC INJ: Adult: Initially 450 units/kg once weekly for 4 weeks, dose to be given weekly as a single dose or in 3-7 divided doses, increase dose after 4 weeks (if a rise in haemoglobin of at least 1 g/100ml not achieved), increased to 900 units/kg once weekly, dose to be given weekly as a single dose or in 3-7 divided doses, if adequate response obtained reduce dose by 25-50%, discontinue treatment if haemoglobin concentration does not increase by at least 1 g/100ml after 8 weeks of therapy (response unlikely). Reduce dose by approximately 25-50% if rise in haemoglobin concentration exceeds 2 g/100 ml over 4 weeks or if haemoglobin concentration exceeds 12 g/100 ml; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose. Discontinue approximately 4 weeks after ending chemotherapy; max. 60 000 units per week
Administration
First dose should be administered under the supervision of a healthcare professional. In the case of IV administration, the solution should be injected over approximately 2 mins (e.g. in haemodialysis patients via the arteriovenous fistula at the end of dialysis). For non-haemodialysis patients, SC administration is preferred in order toavoid puncture of peripheral veins. The recommended Hbtarget is 100-120 gm/L. The target Hb should be determined individually in the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases. MonitorHb at regular intervals until stabilized and periodically thereafter. Remove the cap from the syringe and affix the needle provided.
Compatibility
Do not mix with other medicinal products. Only solutions which are clear or slightly opalescent, colorless and practically free of visible particles should be injected.
Stability
Pre-filled syringes are sterile but do not contain preservatives. Product is for single use in one patient only
Contraindications
Uncontrolled hypertension.
Precautions
Hypertension, thrombocytosis, epilepsy, chronic hepatic failure, malignancies. Correct other causes of anaemia, iron supplements may be necessary. Monitor Hb, BP, platelet count, serum electrolytes. Limit Hb rise to <2 gm/dl per month.
Interactions
Drugs highly bound to red cells e.g. Cyclosporin.
Pregnancy
Benefits probably outweigh risk of anaemia and of blood transfusion in pregnancy.
Lactation
Unlikely to be present in milk. Minimal effect on infant..
Side Effects
Hypertension, shunt thrombosis, anaphylactoid reactions.