Recormon 2000 - Injection Epoetin beta - 2000IU 1 Injection(s) / Injection Radiant Pharmaceuticals Ltd. Indication: Anaemia of chronic renal failure, Anaemia in zidovudine-treated HIV-infected patients, Anemia related to non-myeloid malignant disease chemotherapy, To reduce the need for allogenic blood tranfusion, Anaemia of prematurity. Administration: Administration IV route is recommended for patients receiving hemodialysis because IV route may be less immunogenic SC: inject in abdomen, arm or thigh Adult Dose: Anemia Associated with Chronic Renal Failure Do not increase dose more frequently than q4weeks; decreases in dose can occur more frequently; avoid frequent dose adjustments If hemoglobin rises rapidly (e.g., > 1 g/dL in any 2-week period), reduce dose by 25% or more as needed to reduce rapid responses For patients who do not respond adequately, if hemoglobin has not increased by >1 g/dL after 4 weeks of therapy, increase dose by 25% Patients with chronic renal failure on dialysis Dose if not currently on ESA therapy: 0.6 mcg/kg IV/SC q2week initially Initiate treatment when hemoglobin level 16000 units/week:360 mcg/qmonth... Child Dose: Safety & efficacy not established Contraindication: Uncontrolled hypertension. Neonates: injections containing benzyl alcohol. Mode of Action: Epoetin beta stimulates RBC production in the bone marrows which transmits O2 through out the body. Precaution: Hypertension, history of seizure, thrombocytosis, chronic hepatic impairment, ischaemic vascular disease, malignant tumours, epilepsy; recent MI or CVA. Fe deficiency, infection, inflammatory disorders, haemolysis and aluminium intoxication may decrease response to epoetin beta. Regularly monitor platelet counts and serum-potassium concentrations. Control haematocrit levels. Poorly-controlled hypertension: Monitor BP, Hb and electrolytes. Anaemia (eg, megaloblastic or folic acid): Give Fe supplements when needed. Thromobocytosis: monitor platelet count for 1st 8 wk. Lactation. Lactation: not known if excreted in breast milk, use caution Side Effect: >10% Hypertension (13%),Diarrhea (11%),Nasopharyngitis (11%) 1-10% Headache (9%),Upper respiratory tract infection (9%),Cough (6%),Hypotension (5%),Urinary tract infection (5%),Procedural arteriovenous fistula thrombosis (5%) Frequency Not Defined Coronary artery disease,Anemia,Septic shock,Serious cardiovascular and thromboembolic events,Seizures,Immunogenicity related PRCA,Increased mortality and/or tumor progression in cancer patients,Increased mortality,Concomitant termination of other CRF therapy,Stevens-Johnson syndrome,Toxic epidermal necrolysis Interaction: Antagonises the hypotensive effects of ACE inhibitors and angiotensin-II receptor antagonists and increases risk of hyperkalaemia