Epoetin Alfa

Registered South African indications:

• Anaemia 
• Increase yield in autologous blood donations

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Red cell aplasia from previous erythropoietin use
• Uncontrolled hypertension
• Surgical patients who cannot receive adequate antithrombotic prophylaxis
• For the indication of increasing red cell production in patients scheduled for elective surgery and not participating in autologous blood donation: Severe coronary, peripheral arterial, carotid or cerebral vascular disease; Recent myocardial infarction; Recent cerebrovascular accident

Cautions

• Pregnancy
• Breastfeeding
• Hepatic impairment
• Untreated hypertension
• Hypertensive crisis
• Epilepsy
• Risk factors for venous thromboembolism
• Malignancies
• Hepatitis C associated anaemia

Forms avail. in SA and covered in this monograph: inj

Anaemia associated with chronic kidney disease

• Consult specialist for dosages and regimens

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Titrate initial dosage to achieve an haemoglobin (Hb) between 10-12g/dL

Uptitrate dose if rate of increase in Hb < 1g/dL/month; Down titrate if rate of increase in Hb >1g/dL/2 weeks

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Anaemia (Hb <10g/dL) secondary to chemotherapy in non-myeloid malignancies

• Consult specialist for dosages and regimens

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4 weeks after initiation, reassess Hb and reticulocyte count: 
If rise in Hb >1g/dL OR reticulocyte count > 40 000 cells/μL above baseline, dose remains unchanged;
If rise in Hb <1g/dL OR reticulocyte count < 40 000 cells/μL above baseline, uptitrate dosage as above; If after 4 weeks on uptitrated dosage the rate of rise in Hb is still < 1g/dL/month OR reticulocyte count < 40 000 cells/μL above baseline, then discontinue treatment

Down titrate dose by 25% if rate of rise in Hb >1g/dL/2 weeks

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Aim to maintain Hb between 10-12g/dL

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Increase yield in autologous blood donations in patients with moderate anaemia (packed cell volume 33-39%) if:
- blood conserving procedures are not available/insufficient
- surgery requires more than 4 units for females or more than 5 units for males
- when the period necessary to obtain the required volume of autologous blood is too short

• Consult specialist for dosages and regimens

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Adequate iron supplementation mandatory during treatment course

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Increase red cell production in patients with moderate anaemia (haemoglobin (Hb) 10-13g/dL) scheduled for elective surgery and not participating in autologous blood donation

• Consult specialist for dosages and regimens

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If Hb > 13g/dL, at any point, discontinue treatment

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Treatment of symptomatic anaemia in patients with primary myelodysplastic syndromes who have low serum erythropoietin (<500 mU/mL)

• Consult specialist for dosages and regimens

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Aim to maintain Hb between 10-12g/dL

Decrease epoetin alfa by 25% if rate of increase in Hb >1g/dL/2 weeks

Withhold epoetin alfa if need for transfusion is exceeded; Once Hb drops to <11g/dL, dosing can be restarted

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See additional prescribing points for administration directions

Paed. forms avail. in SA and covered in this monograph: inj

Anaemia associated with chronic kidney disease in patients on haemodialysis

• IV/SC: Initial: 50 IU/kg, 3 times a week; Titrate by 25 IU/kg/dose at intervals of 4 weeks to 75-300μ/kg/week; Maintenance: 25-100u/kg in 1-3 doses per week

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Titrate initial dosage to achieve an haemaglobin (Hb) between 9.5-11g/dL

Downtitrate if Hb >11g/dL OR if rate of increase in Hb >2g/dL/month

Pregnancy

• Caution
• There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicity. Consequently, epoetin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus. 
• The use of epoetin alfa is not recommended in pregnant surgical patients participating in an autologous blood predonation

Breastfeeding

• Caution; not recommended
• It is not known whether exogenous epoetin alfa is excreted in human milk. Epoetin alfa should be used with caution in breastfeeding women. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with epoetin alfa should be made taking into account the benefit of breastfeeding to the child and the benefit of epoetin alfa therapy to the woman
• The use of epoetin alfa is not recommended in breastfeeding surgical patients participating in an autologous blood predonation programme

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Prohibited - At all times

Central Nervous System Disorders

• Headache
• Seizures

Cardiovascular Disorders

• Hypertension
• Venous thromboses
• Arterial thromboses
• Hypertensive crisis

Respiratory Disorders

• Cough
• Respiratory tract congestion

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting

Endocrine and Metabolic Disorders

• Hyperkalaemia
• Acute porphyria

Musculoskeletal Disorders

• Arthralgia
• Bone pain
• Myalgia
• Extremity pain

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Angioneurotic oedema

Immune, Blood and Lymphatic System Disorders

• Pure red cell aplasia
• Thrombocythaemia
• Hypersensitivity reactions
• Pyrexia
• Influenza-like illness
• Anti-erythropoietin antibody positive

Others

• Chills

No information available

• Iron studies
• Full blood count
• Blood pressure

Specific cases may require

• Blood smear
• Electrolytes
• Renal function

Administration directions

• DO NOT administer via IV infusion
• IV injection: inject over 1-5min
• SC injection: Maximum volume per injection site is 1 ml. In case of larger volumes, more than one injection site should be used. Sites: limbs or the anterior abdominal wall.
• Do not dilute or transfer to any container. Do not administer in conjunction with other agents

Epoetin alfa is an erythropoiesis-stimulating glycoprotein. It is involved at a cellular level in the regulation of erythrocyte differentiation and results an increase in the number of erythrocytes, the haemoglobin values, reticulocyte counts and Fe-incorporation rate.

Injection (per ml) 1000iu

• Eprex Pre-filled (Janssen) originator

Injection (per 0.5ml) 2000iu

• Eprex (Janssen) originator

Injection (per 0.4ml) 4000iu

• Eprex (Janssen) originator

Injection (per 0.6ml) 6000iu

• Eprex (Janssen) originator

Injection (per ml) 40000iu

• Eprex Pre-filled (Janssen) originator