Renogen

Renogen

epoetin alfa

Manufacturer:

Etana Biotech
Concise Prescribing Info
Contents
Recombinant human erythropoietin α
Indications/Uses
Anemia caused by renal insufficiency in patients w/ chronic renal failure w/ or w/o hemodialysis; non-myeloid malignancy chemotherapy or other factors of cancer patients eg, Fe or folate deficiency, hemolysis or intestinal tract bleeding.
Dosage/Direction for Use
Treatment Patients w/ hemodialysis Initially 150 IU/kg/wk. W/ non-hemodialysis Initially 100 IU/kg/wk. Increased hematocrit by <0.5% vol May increase dose to 15-30 IU/kg after 4 wk. Max: Not >30 IU/kg/wk. Maintenance Baseline Hb ≥3g/dL 25 U/kg/dose, Hb ≥2-<3 g/dL 20 U/kg/dose, Hb >1-<2 g/dL at 12 wk dose increase 15 U/kg/dose.
Contraindications
Hypersensitivity to Renogen or other erythropoietin prep. Patients w/ uncontrolled severe HTN; concurrent infection. Patient who develop pure red cell aplasia following treatment w/ any erythropoietin should not receive epoetinum-α or any erythropoietin.
Special Precautions
Closely monitor & control BP. Sudden stabbing migraine-like headache. Discontinue therapy if anti-erythropoietin, Ab-mediated PRCA is suspected; BP cannot be controlled. Patients w/ epilepsy, history of seizures, or medical conditions associated w/ a predisposition to seizure activity eg, CNS infections & brain metastases; underlying haematologic diseases; porphyria; cancer. Increased incidence of thrombotic vascular events. Closely monitor Hb conc. Platelet count should be regularly monitored during 1st 8 wk of therapy. Other causes of anaemia should be evaluated & treated prior to initiation of therapy & 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 & adult perisurgery patients w/o autologous blood donation. Not recommended in perisurgery patients w/ a baseline Hb of >13 g/dL. Chronic liver & renal failure. Pregnancy & lactation.
Adverse Reactions
Dose-dependent BP increase, diarrhoea, nausea, vomiting, pyrexia, headache, influenza-like illness, hypersensitivity reactions, hypertensive crisis w/ encephalopathy-like symptoms & seizures, thrombotic vascular events.
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
Renogen inj 4,000 IU/mL
Packing/Price
(pre-filled syringe) 1 mL x 2 × 1's (Rp275,000/pre-filled syringe)
Form
Renogen inj 3,000 IU/mL
Packing/Price
(pre-filled syringe) 1 mL x 2 × 1's (Rp165,000/pre-filled syringe)
Form
Renogen inj 5,000 IU/0.5 mL
Packing/Price
(pre-filled syringe) 0.5 mL x 2 × 1's (Rp350,000/pre-filled syringe)
Form
Renogen inj 2,000 IU/mL
Packing/Price
(pre-filled syringe) 1 mL x 2 × 1's
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