Recormon 5000 IU Injection

    Recormon 5000 IU

    Epoetin beta

    Category: Injection

    Manufacturer: F. Hoffmann-La Roche Ltd.

    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. Uncontrolled hypertension. Neonates: injections containing benzyl alcohol.
    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 < 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
    Antagonises the hypotensive effects of ACE inhibitors and angiotensin-II receptor antagonists and increases risk of hyperkalaemia
    Uncontrolled hypertension. Neonates: injections containing benzyl alcohol.
    >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
    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
    The therapeutic range of Recormon is wide and individual response to therapy must be considered when Recormon treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis which may be associated with life-threatening complications of the cardiovascular system. In case of excessive hemoglobin levels, Recormon should be temporarily withheld. If clinically indicated, phlebotomy may be performed.
    Store in a refrigerator 2°C–8°C. Keep the vial/cartridge/pre-filled syringe in the outer carton, in order to protect from light
    Drugs for Haemolytic Hypoplastic & Renal Anemia
    Epoetin beta stimulates RBC production in the bone marrows which transmits O2 through out the body.
    Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. For epoetin beta, all safety information with regard to exposure to Recormon during pregnancies has been gained from post-marketing experience. A review of the available post-marketing data does not show evidence of a causal association between harmful effects with respect to pregnancy, embryonal/fetal development or postnatal development and treatment with Recormon. However in the absence of clinical study data, caution should be exercised when prescribing to pregnant women.Lactation: Only limited experience in human lactation has been gained. Endogeneous erythropoietin is excreted in breast milk and readily absorbed by the neonatal gastrointestinal tract. A decision on whether to continue or discontinue breastfeeding or to continue or discontinue therapy with epoetin beta should be made taking into account the benefit of breastfeeding to the child and the benefit of epoetin beta therapy to the woman.
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