Erykine

Erykine

epoetin alfa

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Epoetin α
Description
ERYKINE 2,000: Each Pre-Filled Syringe of 1.0 mL contains: Recombinant Human Erythropoietin Alfa 2,000 IU.
ERYKINE 4,000: Each Pre-Filled Syringe of 1.0 mL contains: Recombinant Human Erythropoietin Alfa 4,000 IU.
Excipients/Inactive Ingredients: Human Serum Albumin, Sodium Citrate, Sodium Chloride, Citric Acid.
Action
Pharmacology: Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid  progenitors in the bone marrow. Recombinant Human Erythropoietin (Epoetin Alpha), a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous Erythropoietin. It has a molecular weight of 30,400 daltons and is produced by mammalian cells into which the Human Erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural Erythropoietin.
Within the therapeutic dose range, detectable levels of plasma Erythropoietin are maintained for at least 24 hours.
Erythropoietin has been shown to stimulate erythropoiesis in anemic patients with Chronic Renal Failure (CRF), including both patients on dialysis and those who do not require regular dialysis. The first evidence of response to the three times weekly administration of Erythropoietin is an increase in the reticulocyte count within 10 days followed by increase in the red cell count, hemoglobin, and hematocrit, usually within 2-6 weeks. Erythropoietin has been shown to increase hematocrit and decrease transfusion requirements after the first month of therapy (months 2 and 3), in anemic cancer patients undergoing chemotherapy. Response to Erythropoietin in zidovudine-treated HIV-infected patients is manifested by reduced transfusion requirements and increased hematocrit.
Indications/Uses
Anaemia Associated with Chronic Renal Failure. Anaemia Associated with Chronic Renal Failure in Hemodialysis in Adults, on Peritoneal Dialysis and Non-dialysis Adults: ERYKINE is indicated for the treatment of anemia associated with CRF, including patients on dialysis (ESRD) and patients not on dialysis. ERYKINE is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients.
Treatment of Anemia in Cancer Patients on Chemotherapy: ERYKINE is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Treatment of Anemia in Zidovudine-treated HIV-infected Patients: ERYKINE is indicated for the treatment of anemia related to therapy with zidovudine in HIV-infected patients. ERYKINE is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determination) and to decrease the need for transfusions in these patients.
Reduction of Allogeneic Blood Transfusion in Surgery Patients: ERYKINE is indicated for the treatment of anemic patients (hemoglobin > 10 to ≤ 12 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. ERYKINE is indicated for patients at high risk for preoperative transfusions with significant, anticipated blood loss.
ERYKINE is not indicated for anemic patient who are willing to donate autologous blood. The safety of the preoperative use of ERYKINE has been studied only in patients who are receiving anticoagulant prophylaxis.
Dosage/Direction for Use
Anemia Associated with Chronic Renal Failure: The recommended range for the starting dose of ERYKINE is 50 to 100 Unit/kg Three Times Weekly for adult patients. The dose of Erythropoietin should be reduced as the hematocrit approaches 36% or increase by more than 4 point in any 2-week period. Erytropoietin may be given either as an IV or SC injection. During therapy, haematological parameter should be monitored regularly. Dose adjustment should not be made more frequently than once a month, unless clinically indicated.
The haemoglobin concentration aimed for should be between 10 to 12 g/dL.
Treatment of Anemia In Cancer Patients on Chemotherapy: The recommended dose of ERYKINE for adults is 150 - 300 Units/kg, subcutaneously, three times weekly or 40,000 Units subcutaneously once in a week. Baseline endogenous serum Erythropoietin levels varied among patients with cancer related anemia. Treatment of patients with grossly elevated serum Erythropoietin levels (e.g. > 200 mUnits/mL) is not recommended. The hematocrit should be monitored on a weekly basis in patients receiving ERYKINE therapy until hematocrit becomes stable.
The haemoglobin concentration aimed for should be between 10 to 12 g/dL and it should not be exceeded.
Zidovudine-treated HIV-infected Patients: Starting Dose: Starting dose for adult patients with serum Erythropoietin levels ≤ 500 mUnits/mL who are receiving a dose of zidovudine ≤ 4,200 mg/week, the recommended starting dose of ERYKINE is 100 Units/kg as an intravenously or subcutaneously injection, 3 times weekly for 8 weeks. Prior to beginning ERYKINE therapy, it is recommended that the endogenous serum Erythropoietin level be determined (prior to transfusion). Available evidence suggests that patients receiving zidovudine with endogenous serum Erythropoietin levels > 500 mUnits/mL are unlikely to respond to therapy with Erythropoietin.
The haemoglobin concentration aimed for should be between 10 to 12 g/dL.
Reduction of Allogeneic Blood Transfusion in Surgery Patients: The recommended dose of ERYKINE is 300 Units/kg/day, subcutaneously, for 10 days before surgery, on the day of surgery, and for 4 days after surgery. Prior to initiating treatment with ERYKINE, a hemoglobin should be obtained to establish that it is > 10 to ≤ 13 g/dL. An alternate dose schedule is 600 Units/kg Erythropoietin, subcutaneously, in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery. All patients should receive adequate iron supplementation. Iron supplementation should be initiated no later than the beginning of treatment with Erythropoietin and should continue throughout the course of therapy.
The haemoglobin concentration aimed for should be between 10 to 12 g/dL.
Overdosage
The maximum amount of Erythropoietin that can be safely administered in single or multiple doses has not been determined. Doses of up to 1,500 Units/kg 3 times weekly for 3 - 4 weeks have been administered to adults without any direct toxic effects of Erythropoietin.
Contraindications
This product can't be used with these situation: Uncontrolled hypertension.
Known hypersensitivity to mammalian cell-derived products.
Known hypersensitivity to albumin (human).
Patients who develop antibody mediated PRCA following treatment with erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.
Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Special Precautions
Please consult with the doctor if you experience the things as follows: Erythropoietin alfa should be used with caution in patients with chronic-liver failure. The safety of Erythropoietin alfa has not been established in patients with hepatic dysfunction. Due to decrease metabolism, patients with hepatic dysfuction may have been increased erythropoiesis with Erythropoietin alfa.
In all patients, hemoglobin concentration should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin concentration above the range for the indication of use.
The safety and efficacy of Erythropoietin alfa therapy have not been established in patients with underlying haematologic diseases (e.g haemolytic anaemia, sickle cell anaemia, thalasemia).
It recommended that platelet count should be regularly monitored during the fisrt 8 weeks of therapy.
Antibody mediated pure red cell aplasia (PRCA) has been rarely reported after months to years of SC Erythropoietin alfa treatment. In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1 to 2g/dL per month) with increased need for transfusions, a reticulocyte count should be obtained and typical cause of non response (e.g. Iron folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis, and bone marrow fibrosis of any origin) should be investigated. If the reticulocyte count corrected for anemia (i.e the reticulocyte index) is low (<20,000/mm3 or <20,000/ul or <0,5%) platelet and white blood cell counts are normal, and if no other cause of loss of effect has been found, anti erythropoietin antibodies should be determined and a bone marrow examination should be considered for diagnosis of PRCA. If anti-erythropoietin, antibody mediated PRCA is suspected, therapy with Erythropoietin alfa, should be discontinued immediately. No other erythropoietic therapy should be commenced because of the risk of cross reaction. Appropriate therapy, such as blood transfusions, may be given to patients when indicated.
Cancer patients on Erythropoietin alfa should have haemoglobin levels measured on a regular basis until a stable level is achieved and periodically thereafter.
The safety and efficacy of Erythropoietin therapy have not been established in patients with a known history of a seizure disorder or underlying hematologic disease (e.g. sickle cell anemia, myelodysplastic syndromes, or hypercoagulable disorders).
Hematology: Exacerbation of porphyria has been observed rarely in patients with CRF treated with Erythropoietin. Erythropoietin should be used with caution in patients with known porphyria.
Iron evaluation: Transferrin saturation should be at least 20% and ferritin should be at least 100 ng/mL, transferrin saturation (serum iron divided by iron binding capacity) and serum ferritin, should be evaluated. Virtually all patients will eventually require supplemental iron to increase or maintain transferrin saturation to levels which will adequately support erythropoiesis stimulated by Erythropoietin.
CRF Patients: Hypertension: patients with uncontrolled hypertension should not be treated with Erythropoietin, blood pressure should be controlled adequately before initiation of therapy. During the early phase of treatment when the hematocrit is increasing, approximately 25% of patients on dialysis may require initiation of, or increases in, antihypertensive therapy. Hypertensive encephalopathy and seizures have been observed in patients with CRF treated with Erythropoietin.
Seizures : seizures have occurred in patients with CRF participating in Erythropoietin clinical trials. It is recommended that the dose of Erythropoietin be decreased if the hematocrit increase exceeds 4 points in any 2-week period.
Thrombotic events: during hemodialysis, patients treated with Erythropoietin may require increased anticoagulation with heparin to prevent clotting of the artificial kidney.
Effect on ability and use machines: No studies on the effects of Erythropoietin alfa on the ability to drive and use machines have been performed.
Use in Pregnancy: In animal studies, Erythropoietin alfa has been shown to decrease foetal body weight, delay assification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose. These changes are interpreted as being secondary to decreased maternal body weight gain.
There are no adequate and well controlled studies in pregnant women.
Use in Lactation: Erythropoietin is present in human milk. However, it is not known whether Erythropoietin alfa is distributed into human milk, Erythropoietin alfa should be used with caution in nursing woman.
In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of erythropoietin alfa is not recommended.
Use in Children: The safety and efficacy of Erykine in paediatric patients have not yet been established.
Use In Pregnancy & Lactation
Use in Pregnancy: In animal studies, Erythropoietin alfa has been shown to decrease foetal body weight, delay assification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose. These changes are interpreted as being secondary to decreased maternal body weight gain.
There no adequate and well controlled studies in pregnant women.
Use in Lactation: Erythropoietin is present in human milk. However, it is not known whether Erythropoietin alfa is distributed into human milk, Erythropoietin alfa should be used with caution in nursing woman.
Adverse Reactions
ERYKINE is generally well tolerated. The adverse events reported are frequent sequelae of disease and are not necessarily attributable to Erythropoietin therapy. The events reported in greater than 5% of patients treated with Erythropoietin during the blinded phase were: hypertension, headache, arthralgia, nausea, edema, fatigue, diarrhea, vomiting, chest pain, skin reaction (administration site), asthenia, dizziness, clotted access, pyrexia, constipation, deep vein thrombosis. Events reported to have occurred within several hours of administration of Erythropoietin were rare, mild, and transient, and included injection site stinging in dialysis patients and flu-like symptoms such as arthralgias and myalgias.
Drug Interactions
No evidence exist that indicates that treatment with Erythropoietin alfa alters the metabolism of other drugs. Drugs that decrease erythropoiesis may decrease the response to Erythropoietin alfa.
No evidence exist that indicates an interaction between Erythropoietin alfa and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour cells from biopsy specimens in vitro.
The effect of Erythropoietin alfa may be potentiated by the simultaneous therapeutic administration of a haematinic agents, such as ferrous sulphate, when a deficiency state exist.
Caution For Usage
Do not shake as vigorous shaking may denature any glycoprotein, rendering it biologically inactive. Use aseptic techniques in drug administration. Use one dose Pre-Filled Syringe. Discard unused portion, do not dilute or administer in conjunction with other solutions.
Incompatibilities: Do not dilute or transfer to any other container. Do not administer by IV infusions or in conjugation with other drug solutions.
Storage
Store at 2°- 8°C, do not freeze or shake.
Shelf life: 24 month after the date of production.
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Inj (clear, colorless, preservative free liquid in a pre-filled syringe) 2,000 IU/mL x 1's. 4,000 IU/mL x 1's.
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