Epofit 4000IU (Recombinant human Erythropoietin alfa/ Epoetin alfa)
Description of Epofit 4000IU
Epofit 4000IU is a growth factor produced in the kidneys which stimulates the production of red blood cells. It acts by promoting the division and differentiation of committed erythroid progenitors in the bone marrow. Epofit 4000IU was developed by Amgen Inc. in 1983 as the first rhVintor commercialized in the United States, followed by other alfa and beta formulations. Epofit 4000IU is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is needed for the treatment of patients with Anemia along with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a maximum risk for preoperative blood loss from surgical procedures.
INDICATIONS of Epofit 4000IU
Epofit 4000IU injection is indicated for the treatment of Anemia due to chronic kidney disease including patients on dialysis or without dialysis to reduce the requirement of RBC transfusion
Epofit 4000IU is indicated to decrease the uses for allogeneic RBC transfusions among patients with perioperative haemoglobin > 10 to ≤ 13 g/dL who are at serious risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. Epofit 4000IU is not used for patients who are willing to donate autologous blood pre-operatively.
Epofit 4000IU injection is indicated for the treatment of Anemia due to Zidovudine given ≤ 4200 mg/week in HIV infection patients with levels of erythropoietin endogenous serum of ≤ m units/mL.
Epofit 4000IU injection is indicated for the treatment of Anemia due to effect of concomitant myelosuppressive chemotherapy
MECHANISM OF ACTION of Epofit 4000IU
Epofit 4000IU regulates erythropoiesis by stimulating the differentiation and multiplication of erythroid harbinger, stimulating the release of reticulocytes into the circulation, and synthesis of cellular haemoglobin. Recombinant human erythropoietin is available as epoetin alfa and epoetin beta which are required in the management of anaemia’s along with CRF, cancer chemotherapy and anti-aids drug zidovudine.
ADME of Epofit 4000IU
Absorption: Duration to peak plasma concentration of Epofit 4000IU is 20 to 25 hours and bioavailability of SC injectable Epofit 4000IU is much lower than IV injection and is 20-24%.
Distribution: Volume of distribution is range of 40-63.80 ml/kg and Epofit 4000IU has no plasma protein binding
Metabolism: Bounding of erythropoietin and epoetin alfa to EPO-R causes to cellular internalization, which includes the degradation of the ligand. Erythropoietin and epoetin alfa may also be disgraced by the reticuloendothelial scavenging pathway or lymphatic system.
Elimination: Epofit 4000IU injection are cleared through uptake and degradation via the EPO-R-expressing cells and may also involve other cellular pathways in the interstitium. Only a little amount of unchanged epoetin alfa is found in the urine.
Half-life in adult is 4 hours and for children is approx. 6 hours.
Adult and paediatric with CRF the half-life is 4 to 13 hours.
SIDE EFFECTS of Epofit 4000IU
The injection Epofit 4000IU has some adverse reaction like :
• High level in mortality, Myocardial infarction, stroke and thromboembolism
• Increased mortality/ harm of progression tumor or recurrence in patients.
• High blood pressure
• Serious allergic reactions
• Severe cutaneous reaction
PRECAUTIONS of Epofit 4000IU
- Cancer patients will Increased tumor development rate when dosed to achieve haemoglobin level of >12 mg/ld.
• Increase incidence of death, myocardial infarction (MI), stroke, and thromboembolism: while Using ESAs to aim haemoglobin level of >11 g/dL rises risk of severe adverse cardiovascular reactions
• In Cases of PRCA and of severe Anemia, with or without other cytopenia’s that appears following the growth of neutralizing antibodies to erythropoietin resulted in patients treated with epoetin alfa
• Special caution usage in hypertension, iron deficiency, folate or B12 deficiency, congestive heart failure (CHF), coronary artery disease (CAD), seizure disorder, sickle-cell disease, haemolytic Anemia, porphyria, hematologic disorders
• In Chronic renal failure patients at starting of treatment, transferrin saturation should be ≥20% and ferritin ≥100 ng/mL
• Patients go through surgery are at high risk for DVT; concomitant DVT prophylaxis is strongly recommended
• In Zidovudine-treated patients may have response only when zidovudine dosage <4200 mg/wk. and endogenous epoetin <500 U/mL
• Patients Contains albumin; may carry extremely specific risk for transmission or viral diseases or Creutzfeldt-Jakob disease.
DRUG INTERACTION of Epofit 4000IU
Combination with dichlorphenamide and Epofit 4000IU both decrease serum potassium use with caution and monitor
Epofit 4000IU co administration with methyltestosterone will rises effects of epoetin alfa by pharmacodynamic synergism. Because of potential adverse effects of drug combination should be avoided
Concomitant use with danazol and fluoxymesterone, oxandrolone, oxymetholone will increase effects of epoetin alfa by pharmacodynamic synergism. Androgens used will decrease necessary dose of epoetin alfa.
CONTRAINDICATION of Epofit 4000IU
Epofit 4000IU injection contraindicated to Uncontrolled hypertension
Epofit 4000IU injection contraindicated to Pure red cell aplasia which started after treatment with Epofit 4000IU
Epofit 4000IU injection contraindicated to Serious allergic reactions
PREGNANCY OF Epofit 4000IU
The defined available data on pregnancy women have insufficient to describe a drug related risk of adverse development outcomes. Epofit 4000IU from multiple dose which contains benzyl alcohol is contraindicated to pregnant women.
If pregnant women required therapy with Epofit 4000IU then administer benzyl alcohol free formulation to avoid harm to foetus.
LACTATION OF Epofit 4000IU
Advise the breast-feeding women not to feed for at least 2 weeks after the last dose. Possible similar harm to infants exposed to benzyl alcohol through human milk.
DOSAGE of Epofit 4000IU
Zidovudine-treated Patients with HIV-infection - Starting Dose:
The prescribed initial dose in adults is 100 Units/kg as an IV or SC injection 3 times per week. Discontinue Epofit 4000IU if a high level in haemoglobin is not attain at a dose of 300 Units/kg for 8 weeks.
Patients on Cancer Chemotherapy
Initiate Epofit 4000IU in patients on cancer chemotherapy only if the haemoglobin is less than 10 g/dL, and if there is a lowest of two additional months of planned chemotherapy.
Use the minimal dose of VINTOR necessary to avoid RBC transfusions.
Usually Starting Dose: For Adults administer the dose of 150 Units/kg subcutaneously 3 times per week until finishing of a chemotherapy course or 40,000 Units subcutaneously weekly until finishing of a chemotherapy course. Pediatric Patients (5 to 18 years): 600 Units/kg intravenously weekly until finishing of a chemotherapy course.
Epofit 4000IU overdose can cause by above the desired level of haemoglobin levels, which should be monitor with discontinuation or reduction of Epofit 4000IU dosage with phlebotomy.
Patients with Chronic Kidney Disease
For all patients with CKD:
When initiate or adjusting treatment, check the haemoglobin levels at least weekly until stable, then check at least monthly.
Do not increase of the dose more frequently than once every 4 weeks. decrease in dose can occur more regularly. Avoid frequent dose adjustments.
If the haemoglobin rises fastly, reduce the dose of Epofit 4000IU by 25% or more as required to decrease fast responses.
For adult patients with CKD on dialysis:
• Initiate Epofit 4000IU treatment when the haemoglobin level is less than 10 g/dL.
• If the haemoglobin level approaches or exceeds 11 g/dL, reduces the dose of Epofit 4000IU .
• The usual starting dose for adult patients is 50 to 100 Units/kg 3 times weekly IV or SC. The intravenous route is prescribed for patients on haemodialysis.
For paediatric patients with CKD:
Initiate Epofit 4000IU treatment only when the haemoglobin level is less than 10 g/dL.
If the haemoglobin level access or exceeds 12 g/dL, decrease or interrupt the dose of Epofit 4000IU .
The usual initiate dose for paediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly intravenously or subcutaneously.
The recommended Epofit 4000IU injections are:
• Epofit 4000IU dose given is 300 Units/kg per day subcutaneously (SC) for 15 days total: given daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery.
• Epofit 4000IU dose given is 600 Units/kg subcutaneously (SC) in 4 doses given the patients 21, 14, and 7 days before surgery and on the day of surgery.
STORAGE of Epofit 4000IU
The drug Epofit 4000IU injection Store at 2 ℃ to 8 ℃.
Avoid using of shaken or frozen Epofit 4000IU injection, do not shake
Store the injection in original container until use to away from light
If dose is failed to take then immediately take the dose you remember before next dose or leave the missed, if next dose time arrived. Do not take double dose at a time. Take advice of the doctor about missed dose
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