Hemactiv

Hemactiv

epoetin alfa

Manufacturer:

Laboratorio Elea

Distributor:

Cathay YSS

Marketer:

Biocare Lifesciences
Concise Prescribing Info
Contents
Epoetin α
Indications/Uses
Symptomatic anemia associated w/ chronic renal failure (CRF) in adults & childn 1-18 yr on hemodialysis & adults on peritoneal dialysis. Severe anemia of renal origin accompanied by clinical symptoms in adults w/ renal insufficiency not yet undergoing dialysis. Anemia & reduction of transfusion requirements. Increase yield of autologous blood in adults in predonation programme. For non-Fe deficient adults prior to major elective orthopedic surgery having high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.
Dosage/Direction for Use
IV/SC CRF Adult 50-100 IU/kg 3 times/wk. Childn 25-50 IU/kg 3 times/wk. Phase of correction 50 IU/kg 3 times/wk. Increase or reduce at 25 IU/kg 3 times/wk in steps of 4 wk. Should not exceed 3 x 200 IU/kg. Phase of maintenance 75-300 IU/kg/wk. Adults w/ cancer Initially 150 IU/kg as SC 3 times/wk. May increase to 300 IU/kg 3 times/wk if the Hb has increased <1 mg/dL (<0.62 mmol/L) or the reticulocytes has increased to <40,000 cells/μL above baseline. Surgery in patients in an autologous pre-donation program 300-600 IU/kg 2 time/wk as IV inj for 3 wk w/ at least 200 mg of elemental Fe. Scheduled for elective surgery 600 IU/kg wkly for 3 wk (days -21, -14, & -7) as SC prior to surgery & the day of the surgery.
Contraindications
Hypersensitivity to epoetin α, products derived from mammalian cells or albumin. Uncontrolled HTN. Patients scheduled for major elective surgery not participating in autologous blood pre-donation program & not having CAD, peripheral artery disease, carotid arterial disease or stroke, including patients w/ recent MI or stroke. Surgical patients who for any reason cannot receive adequate antithrombotic prophylaxis. Patients developing pure red cell aplasia w/ any erythropoietin.
Special Precautions
Serious allergic reactions. Increased CV, thrombotic vascular events & mortality. Monitor closely the Hb conc during treatment & Hb conc above the range of use. Patients w/ cancer, CRF. Monitor CBC regularly w/ Hb conc in patients w/ CRF until a stable level is achieved & periodically thereafter. Monitor BP especially at the beginning of treatment. Increase the dose of heparin during hemodialysis due to increased vol of the cell mass. Increased risk of post-op thrombotic events in patients w/ Hb >13 mg/dL. HTN, epilepsy, history of seizures, conditions associated w/ predisposition to seizure activity as CNS infections or brain metastases. Patients w/ anemia associated w/ hepatitis C. Discontinue if pure RBC aplasia; erythropoietin & other erythropoietic products Ab are detected. Treat other causes of anemia (eg, Fe deficiency, hemolysis, blood loss, deficiency of vit B12 or folate) before starting treatment. Contains albumin derived from human blood; rare remote risk for transmission of viral diseases eg, Creutzfeldt Jacob disease. Increase in platelet counts during the 1st 8 wk of treatment. Patients w/ gout, chronic liver disease. Pregnancy & lactation.
Adverse Reactions
Increased BP, worsening of preexisting HTN. Hypertensive crisis w/ encephalopathy; increased incidence of thrombotic vascular events; hypersensitivity reactions (eg, rash, anaphylactoid reactions & angioedema); diarrhea, nausea, vomiting, pyrexia, chills, inj site reactions, headache & flu-like syndrome. Immunogenicity; seizures.
Drug Interactions
Enhanced effect w/ anti-anemia agent. Decreased response w/ drugs lowering erythropoiesis. Co-administration w/ cyclosporine.
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
Hemactiv soln for inj 4,000 IU/mL
Packing/Price
1's
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