EPOTIN
EPOETIN ALFA · by JULPHAR PAKISTAN
Composition
Inj 1000 IU/2000 IU/3000 IU/4000 IU/5000 11.1/6000 11.1/8000 IU/10000 111/40000 Epoetin alfa 1000 IU/2000 IU/3000 IU/4000 IU/5000 IU/6000 IU/8000 IU/10000 IU/40000 IU; phosphate buffered solution
Indications & Dosage
Symptomatic anaemia associated with chronic renal failure in patients on haemodialysis: BY IV INJ: Adult: Initially 50 units/kg 3 times a week, adjusted in steps of 25 units/kg 3 times a week, dose adjusted according to response at intervals of at least 4 weeks; maintenance 25-100 units/kg 3 times a week, IV Inj to be given over 1-5 minutes, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100ml over4 weeks or if haemoglobin concentration exceeds12 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 Symptomatic anaemia associated with chronic renal failure in adults on peritoneal dialysis: BY IV INJ: Adult: Initially 50 units/kg twice weekly; maintenance 25-50 units/kg twice weekly, IV Inj to be given over 1-5 minutes, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100ml 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 Severe symptomatic anaemia of renal origin in adults with renal insufficiency not on dialysis: BY IV INJ: Adult: Initially 50 units/kg 3 times a week, increased insteps of 25 units/kg 3 times a week, adjusted according to response, dose to be increased at intervals of at least4 weeks; maintenance 17-33 units/kg 3 times a week(max. per dose 200 units/kg 3 times a week), intravenous injection to be given over 1-5 minutes, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100ml 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 Symptomatic anaemia in adults receiving cancer Chemotherapy: BY SC INJ: Adult: Initially 150 units/kg 3 times a week, alternatively initially 450 units/kg once weekly, increased to 300 units/kg 3 times a week, increased if appropriate rise in haemoglobin (or reticulocyte count) not achieved after 4 weeks; discontinue if inadequate response after 4 weeks at higher dose, subcutaneous injection max. 1ml per injection site, reduce dose by approximately 25-50% if rise in haemoglobin concentration exceeds 2 g/100ml 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 To increase yield of autologous blood in predonation programme in moderate anaemia either when large volume of blood required or when sufficient blood cannot be saved for elective major surgery: BY IV INJ: Adult: 600 units/kg twice weekly for 3 weeks before surgery, consult product literature for details and advice on ensuring high iron stores, intravenous injection to be given over 1-5 minutes Moderate anaemia (haemoglobin concentration 10-13 g/100 ml) before elective orthopaedic surgery in adults to reduce exposure to allogeneic blood transfusion or if autologous transfusion unavailable: BY SC INJ: Adult: 600 units/kg once weekly for 3 weeks before surgery and on day of surgery, alternatively 300 units/kg daily for 15 days starting 10 days before surgery, consult product literature for details, subcutaneous injection max. 1ml per injection site
Administration
Patients with CRF on dialysis: May be administered IV Bolus into the venous line after dialysis. Patients with CRF not on dialysis: May be administered IV or SC. For minimal dilution, mix with bacteriostatic 0.9% sodium chloride, containing 20 ml of 0.9% sodium chloride and benzyl alcohol as the bacteriostatic agent. Dilutions of 1:10 and 1:20 (1 part epoetin: 19 parts sodium chloride) are stable for 18 hours at room temperature. Results showed no loss of epoetin alfa after a 1:20 dilution. 250 mcg/ ml albumin remaining after a 1:10 dilution of formulated epoetin alfa should be sufficient to prevent it from binding to commonly encountered containers. Prior to SC administration, preservative free solutions may be mixed with bacteriostatic NS containing benzyl alcohol 0.9% in a 1:1 ratio. Do not shake vial while preparing to avoid denaturing glycoprotein, inactivating drug.
Compatibility
Stable in D10W with albumin 0.05%, D10W with albumin 0.1%. Incompatible with D10W with albumin 0.01%, D10W, NS
Stability
Vials should be stored at 2C-8D (36F-46F). Do not freeze or shake, Vials are stable for 2 weeks at room temperature. Single-dose 1 ml vial contains no preservatives. Use one dose per vial. Do not re-enter vial. Discard unused portions. Multidose 1 ml or 2 ml vial contains preservative. Store at 2C-8C after initial entry and between doses, discard 21 days after initial entry.
Contraindications
Uncontrolled hypertension. Severe coronary, peripheral arterial, carotid or cerebral vascular disease in patients scheduled for major elective orthopaedic surgery and not participating in autologous blood donation, patients unable to receive antithrombin prophylaxis.
Precautions
Chronic hepatic failure, hypertension, ischaemic vascular disease, thrombocytosis, history of epilepsy, pregnancy, Correct other causes of anaemia; iron supplement may be required. Monitor BP Hb, blood 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
Raised BP, headache, thrombosis, flu-like symptoms, seizures, skin reactions, palpebral oedema. Rarely, pure red cell aplasia; withdraw and do not transfer to other erythropoietins.