Indications & Uses
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Therapy with Recormon should be initiated by physicians experienced in the above mentioned indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.Substitution by any other biological medicinal product requires the consent of the prescribing physician.The Recormon pre-filled syringe is ready for use. Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.Recormon in pre-filled syringe is a sterile but unpreserved product. Under no circumstances should more than one dose be administered per syringe.Treatment of anemic patients with chronic renal failure: The solution can be administered subcutaneously or intravenously. In case of intravenous administration, the solution should be injected over approximately 2 minutes, e.g. in hemodialysis patients via the arteriovenous fistula at the end of dialysis.For non-hemodialysed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins.The recommended hemoglobin target is 10 -12 g/dl. The target hemoglobin should be determined individually in the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases. It is recommended that hemoglobin is monitored at regular intervals (e.g. every two to four weeks) until stabilised and periodically thereafter.Treatment with Recormon is divided into two stages: Correction phase-Subcutaneous administration: The initial dosage is 3 x 20 IU/kg body weight per week. The dosage may be increased every 4 weeks by 3 X 20 IU/kg body weight/week if the Hb increase is not adequate (Hb <1.5 g/L per week). The weekly dose can also be divided into daily doses.Intravenous administration: The initial dosage is 3 x 40 IU/kg per week. The dosage may be raised after 4 weeks to 80 IU/kg - three times per week- and by further increments of 20 IU/kg if needed, three times per week, at monthly intervals.For both routes of administration, the maximum dose should not exceed 720 IU/kg per week.
Side Effects
Rarely (≥1/10,000 to ≤1/1,000), skin reactions such as rash, pruritus, urticaria or injection site reactions may occur. In very rare cases (≤1/10,000) anaphylactoid reactions have been reported. However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found. In very rare cases (≤1/10,000), particularly when starting treatment, flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported. These reactions were mild or moderate in nature and subsided after a couple of hours or days.
Cautions & Contraindications
Contraindications
Erythropoietin Beta is contraindicated in patients with: Known hypersensitivity to the active substance or any of the excipients. Poorly controlled hypertension. In the indication "increasing the yield of autologous blood", Recormon must not be used in patients who, in the month preceding treatment, have suffered a myocardial infarction or stroke, patients with unstable angina pectoris, or patients who are at increased risk of deep venous thrombosis such as those with a history of venous thromboembolic disease.