Epoetin alfa


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Increase yield of autologous blood 600 u/kg twice wkly starting 3 wk before surgery. IV/SC Anaemia of chronic renal failure In predialysis and haemodialysis: Initial: 50 IU/kg 3 times weekly via IV Inj over at least 1-5 minutes or as slow IV Inj in patients who have flu-like symptoms as adverse effect. May also be given via SC inj. Doses may be increased in increments of 25 units/kg at 4-week intervals until the target is reached. In peritoneal dialysis: Initial: 50 units/kg SC twice weekly. Weekly maintenance dose: Predialysis: Total max: 450 units/kg in 3 divided doses. Alternatively,  max 20,000 units  via SC injection given once weekly or once every 2 weeks. Haemodialysis: 75-300 units/kg in 3 divided doses. Peritoneal dialysis: 50-100 units/kg in 2 divided doses. Anaemia in zidovudine-treated HIV-infected patients Initial: 100 u/kg 3 times/wk for 8 wk. May increase slowly. Not >300 u/kg 3 times/wk. SC Anemia related to non-myeloid malignant disease chemotherapy Initial: 150 u/kg 3 times weekly or 450 units/kg once weekly, increased after 4-8 weeks to 300 units/kg 3 times weekly, if necessary. Alternatively, 40,000 units once weekly, may increase to 60,000 once weekly units after 4 weeks if necessary. Stop treatment if response is still inadequate after 4 weeks of treatment at this higher dose. To reduce the need for allogenic blood tranfusion 600 u/kg once wkly starting 3 wk before surgery w/ the 4th dose given on the day of surgery.
Dosage Details
Intravenous
Increase yield of autologous blood
Adult: 600 units/kg 2 times a wk starting 3 wk before surgery. May be used in conjunction with an iron supplement.

Parenteral
Anaemia in zidovudine-treated HIV-infected patients
Adult: Titrate dose for patients individually so as to achieve and maintain the lowest haemoglobin level sufficient to avoid the need for blood transfusion and not to exceed 12 g/dL. For patients with serum erythropoietin levels ≤500 mUnits/mL who are receiving zidovudine dose ≤4200 mg/wk: Starting dose: 100 units/kg via SC/IV Inj 3 times a wk for 8 wk, may increase by 50-100 units/kg 3 times a wk at 4-8 wk intervals according to response. Not recommended to administer doses >300 units/kg 3 times a wk.

Parenteral
Anaemia of chronic renal failure
Adult: In predialysis and haemodialysis: Initially, 50 IU/kg 3 times weekly via IV Inj over at least 1-5 minutes or as slow IV Inj in patients who have flu-like symptoms as adverse effect. May also be given via SC inj. Doses may be increased in increments of 25 units/kg at 4-week intervals until the target is reached. In peritoneal dialysis: Initially, 50 units/kg SC twice weekly. Weekly maintenance dose: Predialysis: Total max: 450 units/kg in 3 divided doses. Alternatively,  max 20,000 units  via SC injection given once weekly or once every 2 weeks. Haemodialysis: 75-300 units/kg in 3 divided doses. Peritoneal dialysis: 50-100 units/kg in 2 divided doses.
Child: Haemodialysis: Initially, 50 units/kg 3 times weekly, given via IV inj. May increase dose by increments of 25 units/kg at 4-week intervals until the target Hb concentration is reached (9.5-11 g/mL). Total weekly maintenance dose: Haemodialysis: >30 kg: 90-300 units/kg; 10-30 kg: 180-450 units/kg; <10 kg: 225-450 units/kg. To be given in 3 divided doses.doses.

Subcutaneous
Anaemia related to non-myeloid malignant disease chemotherapy
Adult: Initially, 150 units/kg 3 times weekly or 450 units/kg once weekly, increased after 4-8 weeks to 300 units/kg 3 times weekly, if necessary. Alternatively, 40,000 units once weekly, may increase to 60,000 once weekly units after 4 weeks if necessary. Stop treatment if response is still inadequate after 4 weeks of treatment at this higher dose.

Subcutaneous
Reduce the need for allogeneic blood transfusion
Adult: 600 units/kg once wkly starting 3 wk before surgery with the 4th dose given on the day of the surgery or 300 units/kg daily starting 10 days before surgery and for 4 days after.
Contraindications
Hypersensitivity to albumin (human) or mammalian cell-derived products; uncontrolled hypertension.
Special Precautions
Hypertension; history of seizures; thrombocytosis; chronic liver failure; poor renal function; ischaemic vascular disease; malignant tumours. Increased risk of thrombotic events. Monitor BP during treatment. Regularly monitor platelet counts and serum-potassium concentration. Iron deficiency, infection or inflammatory disorders, haemolysis, or aluminium intoxication will reduce efficacy. Proper dosage control is required to prevent to rapid increase in the haematocrit and haemoglobin levels. Pregnancy; lactation.
Adverse Reactions
Headache, hypertension and seizures. Hypertensive crisis with encephalopathy-like symptoms; thrombosis at vascular access sites and clotting in the dialyser. Transient increases in the platelet count. Flu-like symptoms including chills and myalgia; hyperkalaemia and skin rashes; anaphylactoid reactions. Rarely, pure red cell aplasia after prolonged treatment in patients with prolonged renal failure.
IV/Parenteral/SC: C
Action
Description: Epoetin alfa stimulates the differentiation and proliferation of erythroid precursors, release of reticulocytes into the circulation and synthesis of cellular Hb thus regulating erythropoiesis.
Pharmacokinetics:
Absorption: SC: Slow and incomplete. IV: Rapid.
Distribution: Concentrated in the liver, kidneys and bone marrow.
Metabolism: Some degradation occurs.
Excretion: Mainly in the faeces with small amounts in the urine.
Storage
Refrigerate at 2-8°C. Do not freeze.
Disclaimer: This information is independently developed by MIMS based on Epoetin alfa from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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