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Epiao

Epiao

epoetin alfa

Manufacturer:

Shenyang Sunshine

Distributor:

Bell-Kenz Pharma

Marketer:

AMB HK
Concise Prescribing Info
Contents
Epoetin α
Indications/Uses
Anemia due to chronic renal failure, including patients on hemodialysis (HD) or not on dialysis (ND). Peri-operative patients to reduce the need for allogeneic RBC transfusions. Anemia associated w/ chemotherapy in cancer patients w/ non-myeloid malignancies.
Dosage/Direction for Use
IV/SC Anemia of renal failure Initial dose: Wkly divided dose: 100-150 IU/kg wkly for HD patient, & 75-100 IU/kg for ND patient. May be increased by 15-30 IU/kg wkly if the increment of hematocrit is <0.5 vol%/wk after 4 wk. Max dose increase: 30 IU/kg/wk. Once a wk dose: 10,000 IU/wk for HD or PD adult patient. Maintenance dose: Wkly divided dose: Adjust dose to 2/3 of initial dose once hematocrit reaches 30-33 vol% or Hb reaches 100-110 g/L. Once a wk dose: Reduce dose frequency (eg, once every 2 wk) when hematocrit & Hb count reached the above target. Peri-operative Elective surgery patient (except cardiac surgery) w/ Hb 100-130 g/L 150 IU/kg SC 3 times wkly, starting 10 days prior to, & for 4 days after the surgery. Anemia in cancer patient on chemotherapy Wkly divided dose: Initially 150 IU/kg SC 3 times a wk. May be increased to 200 IU/kg SC 3 times a wk if no significant increase of hematocrit or reduction of transfusion requirement after 8 wk treatment. Once a wk dose: 36,000 IU/wkly SC for 8 wk, if the blood Hb is <110 g/L in male or <100 g/L in female patient.
Contraindications
Hypersensitivity to epoetin α, other mammalian cell derivatives, & human serum albumin. Uncontrolled HTN & combined infection.
Special Precautions
Greater risks for death, serious CV events & stroke if administered in patients w/ chronic renal failure to target Hb levels of ≥13 g/dL. Shortened overall survival &/or increased risk of tumor progression or recurrence in patients w/ breast, non-small cell lung, head & neck, lymphoid, & cervical cancers. Use only for treatment of anaemia due to concomitant myelosuppressive chemotherapy. Not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure; discontinue following the completion of chemotherapy course. Increased rate of DVT in patients not receiving prophylactic anticoagulation. Pure red cell aplasia (PRCA) & severe anaemia, w/ or w/o other cytopenias, associated w/ neutralizing Abs may occur, predominantly when administered by SC in patients w/ chronic failure. PRCA in patients while undergoing treatment for hepatitis C w/ interferon & ribavirin. Evaluate for the etiology of loss in effect including the presence of neutralizing Abs in any patients who develops a sudden loss of response to treatment accompanied by severe anaemia & low reticulocyte count. Permanently discontinue in patients w/ Ab-mediated anaemia. Abs may cross-react w/ other erythropoiesis-stimulating agents. Regularly monitor hematocrit (once a wk in initial treatment phase & twice a wk in maintenance phase) to avoid excessive erythropoiesis & Hb (once every 1-2 wk) when 36,000 IU/mL is used; discontinue if excessive erythropoiesis it occurs or Hb is >120 g/L. Patients w/ known porphyria. Absolute or functional Fe deficiency may develop. Evaluate Fe status, including transferrin saturation & serum ferritin prior to & during therapy. Surgery patients should receive adequate Fe supplementation throughout the course of therapy to support erythropoiesis & avoid depletion of Fe stores. Adequately control BP before initiation of therapy; decrease or w/hold dose if BP is difficult to control. Carefully adjust dose to achieve & maintain HB levels between 10-12 g/dL in chronic renal failure patients on hemodialysis w/ clinically evident ischemic heart disease or CHF. Known history of seizure disorder or underlying hematologic disease (eg, sickle cell anaemia, myelodysplastic syndromes, or hypercoagulable disorders). Treated patients may require increased anticoagulation w/ heparin to prevent clotting of the artificial kidney during hemodialysis. Increased risk of thrombotic events including vascular access thrombosis in adult patients w/ ischemic heart disease or CHF receiving therapy w/ goal of reaching a normal hematocrit (42%). Monitor closely the presence of premonitory neurologic symptoms; pre-existing CV disease. Patients w/ symptoms of cardiac infarction, pulmonary infarction, cerebral infarction or those w/ allergic history of drugs & manifestation of allergy. May diminish efficacy w/ folic acid or vit B12 deficiency; Al intoxication. Avoid potentially hazardous activities eg, driving or operating heavy machinery. Pregnancy & lactation. Premature infants, newborns, & infants. Elderly.
Adverse Reactions
Headache, fever & fatigue. Increases in BP, deterioration of HTN, headache induced by hypertensive encephalopathy & seizures. Increased blood viscosity.
MIMS Class
Haematopoietic Agents
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
Epiao soln for inj 4,000 IU/mL
Packing/Price
1 mL x 1's (P900/box)
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