Epoetin beta


Generic Medicine Info
Indications and Dosage
Intravenous, Subcutaneous
Increase yield of autologous blood
Adult: Dosage is individualised and based on the required amount of pre-donated blood and the endogenous red cell reserve. Usual dosing range: 200-800 international units/kg via IV inj over approx 2 minutes twice weekly (Max: 1,600 international units/kg/week). Alternatively, 150-600 international units/kg via SC inj twice weekly (Max: 1,200 international units/kg/week). Treatment should be given over 4 weeks. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Intravenous, Subcutaneous
Anaemia of chronic renal failure
Adult: Dosage is individualised and adjusted according to target Hb concentration. Correction phase: IV administration (preferred route for patients undergoing haemodialysis): Initially, 40 international units/kg 3 times weekly for 4 weeks; then may increase the dose to 80 international units/kg 3 times weekly based on Hb response. May further increase the dose in increments of 20 international units/kg 3 times weekly at monthly intervals if needed. Max: 720 international units/kg/week. Doses are given via IV inj over approx 2 minutes; may inject via the arteriovenous fistula at the end of dialysis. SC administration (preferred route for patients not on haemodialysis): Initially, 60 international units/kg/week given as a single dose or in 3-7 divided doses. May increase the dose every 4 weeks by 60 international units/kg/week if needed. Max: 720 international units/kg/week. Doses are given via SC inj. Maintenance phase: After reaching the target Hb level, initially reduce to half of the previously administered dose then adjust the dose at intervals of 1-2 weeks according to response. The weekly SC dose may be given as 1 inj per week or in divided doses of 3 times/week or 7 times/week; those who become stable on a once weekly regimen may be switched to once every 2 weeks (dose increase may be necessary). Use the lowest necessary dose to control symptoms of anaemia. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: Same as adult dose.

Subcutaneous
Anaemia of prematurity
Child: As prevention: Infants gestational age <34 weeks birth weight of 750-1,500 g: 250 international units/kg 3 times weekly for 6 weeks. Initiate treatment as early as possible (preferably within 3 days of birth). Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Neonate: As prevention: Gestational age <34 weeks birth weight of 750-1,500 g: 250 international units/kg 3 times weekly for 6 weeks. Initiate treatment as early as possible (preferably within 3 days of birth). Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).

Subcutaneous
Anaemia related to non-myeloid malignant disease chemotherapy
Adult: Dosage is individualised and adjusted according to target Hb concentration. Initially, 30,000 international units (approx 450 international units/kg) weekly, given as a single dose or in 3-7 divided doses. After 4 weeks, the dose may be doubled if needed. Discontinue treatment if no adequate response is achieved after 4 weeks at the higher dose. Max: 60,000 international units/week. Maintenance: After reaching the target Hb level, may reduce the dose by 25-50% to maintain the desired Hb level; consider appropriate dose titration. Continue treatment up to 4 weeks after the completion of chemotherapy. Use the lowest necessary dose to control symptoms of anaemia. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Contraindications
Uncontrolled hypertension. When used for increasing the yield of autologous blood: MI or stroke in the month preceding the treatment, unstable angina pectoris; risk factors of deep venous thrombosis (e.g. history of venous thromboembolic disease).
Special Precautions
Patient with epilepsy, refractory anaemia with excess blasts in transformation, thrombocytosis; history of hypertension or CV, cerebrovascular, or peripheral vascular disease; recent history of bleeding (with or without transfusions); cancer; severe Al overload due to treatment of renal failure; nephrosclerosis who have not initiated dialysis; chronic hepatic failure. Autologous blood donation patients weighing <50 kg. Not recommended for acute correction of severe anaemia or as a substitute for emergency transfusion. Rule out folic acid and vitamin B12 deficiencies before treatment initiation. Neonates and children. Pregnancy and lactation.
Adverse Reactions
Significant: New-onset or exacerbation of hypertension, hypertensive encephalopathy; seizures; pure red cell aplasia (PRCA); increased risk of tumour progression; increase in platelet counts.
Blood and lymphatic system disorders: Leucopenia.
Gastrointestinal disorders: Nausea, vomiting.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: URTI, pneumonia.
Potentially Fatal: CV events, including thromboembolic events and stroke (particularly when administered to a target Hb >12 g/dL); severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis); CV complications (due to excessive increase in packed cell volume) related to misuse.
Monitoring Parameters
Monitor transferrin saturation, serum ferritin, Fe, Hb or haematocrit, platelet count, electrolytes, blood pressure. Assess for signs and symptoms of seizures.
Action
Description:
Mechanism of Action: Epoetin beta is a recombinant human erythropoietin with the same pharmacological activity as endogenous erythropoietin. It induces the formation of erythrocytes by stimulating the proliferation and differentiation processes of the erythroid stem cell compartment. Additionally, it has a stimulatory effect on the proliferation and maturation compartment of the erythron. This results in an increase in Hb formation and an associated acceleration of cell maturation with reduction in the cell cycle time. Furthermore, it accelerates reticulocyte maturation and increases reticulocyte counts.
Pharmacokinetics:
Absorption: Slowly and incompletely absorbed (SC). Bioavailability: 23-42% (SC). Time to peak plasma concentration: 12-28 hours (SC).
Excretion: Elimination half-life: 4-12 hours (IV); 13-28 hours (SC).
Storage
Store between 2-8°C. Do not freeze. Protect from light. May store below 25°C for a single period of up to 3 days.
MIMS Class
Haematopoietic Agents
References
Anon. Epoetin Beta. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 16/01/2024.

Buckingham R (ed). Epoetins. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/03/2023.

Joint Formulary Committee. Epoetin Beta. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/01/2024.

NeoRecormon 6,000 IU Solution for Injection in Pre-filled Syringe (Roche Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 16/01/2024.

Recormon Pre-filled Syringes (Roche [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 16/01/2024.

Roche Products (New Zealand) Limited. NeoRecormon Solution for Injection in Pre-filled Syringe data sheet 20 January 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 06/03/2023.

Disclaimer: This information is independently developed by MIMS based on Epoetin beta 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 © 2024 MIMS. All rights reserved. Powered by MIMS.com
  • Recormon
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in