Recormon 5000

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 IV route is recommended for patients receiving hemodialysis because IV route may be less immunogenic SC: inject in abdomen, arm or thigh

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 < 10 g/dL If hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt dose Once hemoglobin has been stabilized, Epoetin beta may be administered once monthly using a dose that is twice that of the every-two-week dose and subsequently titrated as necessary Switching Patients Currently on Other ESA Receiving epoetin <8000 units/week: 120 mcg/qmonth or 60 mcg/q2week IV/SC Receiving epoetin 8000-16000 units/week: 200 mcg/qmonth or 100 mcg/q2week IV/SC Receiving epoetin >16000 units/week:360 mcg/qmonth or 180 mcg/q2week IV/SC

Safety & efficacy not established

Uncontrolled hypertension. Neonates: injections containing benzyl alcohol.

Epoetin beta stimulates RBC production in the bone marrows which transmits O2 through out the body.

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

>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

Antagonises the hypotensive effects of ACE inhibitors and angiotensin-II receptor antagonists and increases risk of hyperkalaemia