Renogen

Renogen

epoetin alfa

Manufacturer:

Etana Biotech
Full Prescribing Info
Contents
Recombinant human erythropoietin α
Indications/Uses
Patients with anemia caused by renal insufficiency, including patients with hemodialysis and non-hemodialysis due to chronic renal failure.
Patients with anemia caused by non-myeloid malignancy applied chemotherapy, other than those with anemia caused by other factors in the treatment of cancer patients (e.g. iron or folate deficiency, hemolysis or intestinal tract bleeding).
Dosage/Direction for Use
Treatment period: The initial recommended dose is 150 IU/kg body weight per week for patients with hemodialysis and 100 IU/kg body weight per week for patients with non-hemodialysis. If the hematocrit per week is increased by less than 0.5 vol%, the dose can be increased by 15~30IU/kg body weight after 4 weeks, but the maximum increased dose shall not exceed 30IU/kg body weight perweek. The hematocrit shall be increased to 30~33 vol%, but not more than 34 vol%.
Maintenance period: If the hematocrit is up to 30~33 vol% or the hemoglobin (Hb) is up to 90 - 120 g/l, the maintenance treatment period can be started. It is recommended to adjust the dose at the end of 12 weeks treatment whose Hb has fallen greater than 1 g/dL below baseline level should have their dose increased according to schedule below. They are then to be followed up for further 4 weeks to observed the Hb response to the dose increase.
Renogen Dosage Schedule: Baseline Hb - Hb at 12 weeks Dose Increase: >1 to < 2 g/dL 15 U/Kg body weight/dose; ≥2 to < 3 g/dL 20 U/Kg Body weight/dose; ≥ 3g/dL 25 U/Kg body weight/dose.
Contraindications
Patients with uncontrolled severe hypertension.
Those allergic to the drug or other erythropoietin preparations.
Those with concurrent infection, who shall use the drug after the infection is under control.
Patient who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Epoetinum alfa or any other erythropoietin should not receive Epoetinum alfa or any other erythropoietin (see Pure Red Cell Aplasia under Precautions).
Special Precautions
Closely monitor and control blood pressure. Pay particular attention to sudden stabbing migraine-like headache. Discontinue therapy if anti-erythropoietin, Ab-mediated PRCA is suspected; blood pressure cannot be controlled. Patients with epilepsy, history of seizures, or medical conditions associated with a predisposition to seizure activity eg, Central Nervous System infections and brain metastases; underlying haematologic diseases; porphyria; cancer. Increased incidence of thrombotic vascular events. Closely monitor hemoglobin concentration. Platelet count should be regularly monitored during first 8 week of therapy. Other causes of anaemia should be evaluated and treated prior to initiation of therapy and before decision to increase dose. Discontinue if a severe cutaneous reaction eg, Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected. HIV-infected patients. Adult surgery patients in an autologous pre-donation programme and adult perisurgery patients without autologous blood donation. Not recommended in perisurgery patients with a baseline Hb of >13 g/dL. Chronic liver and renal failure. Pregnancy and lactation.
Adverse Reactions
Dose-dependent blood pressure increase, diarrhoea, nausea, vomiting, pyrexia, headache, influenza-like illness, hypersensitivity reactions, hypertensive crisis with encephalopathy-like symptoms and seizures, thrombotic vascular events.
Drug Interactions
Evidence of interaction between Epoetin Alfa and other drugs has not been observed in clinical trials.
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Inj (pre-filled syringe, sterile, clear, colourless, buffered parenteral solution) 2,000 IU/mL x 1 mL x 2's. 3,000 IU/mL x 1 mL x 2's. 4,000 IU/mL x 1 mL x 2's. 5,000 IU/0.5 mL x 0.5 mL x 2's.
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