RECORMON Injection

Epoetin beta
1000 IU
F. Hoffmann-La Roche Ltd.
Pack size 10 Vials (Dry) + 10 Solvent Ampoules (1ml)
Dispensing mode POM
Source SWITZERLAND
AgentIBN KHALDOON DRUG STORE
Retail Price 1000.50 AED

Indications

RECORMON Injection is used for: 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.

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 < 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

Child Dose

Safety & efficacy not established

Renal Dose

Administration

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

Contra Indications

Uncontrolled hypertension. Neonates: injections containing benzyl alcohol.

Precautions

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

Pregnancy-Lactation

Interactions

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

Adverse Effects

Side effects of Epoetin beta : >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

Mechanism of Action

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

Note

RECORMON 1000 IU Injection manufactured by F. Hoffmann-La Roche Ltd.. Its generic name is Epoetin beta. RECORMON is availble in United Arab Emirates. Farmaco UAE drug index information on RECORMON Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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