Recormon 4000 Iu 6 Prefilled Syrige (Refrigerator)

Recormon contains epoetin beta (recombinant human erythropoietin) as active substance, a hormone which stimulates the production of red blood cells.

Recormon is indicated for:

• Treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis.


• Treatment of symptomatic renal anemia in patients not yet undergoing dialysis.


• Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks.


• Prevention and treatment of anemia in adult patients with solid tumors and treated with platinumbased chemotherapy prone to induce anemia (cisplatin, carboplatin).


• Treatment of anemia in adult patients with multiple myeloma, low grade nonHodgkin’s lymphoma or chronic lymphocytic leukemia, who have a relative erythropoietin deficiency and are receiving antitumor therapy.


• Increasing the yield of autologous blood from patients in a predonation program.


• Its use in this indication must be balanced against the reported increased risk of thromboembolic events.


• Treatment should only be given to patients with moderate anemia (Hb 10 13 g/dl, no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood.

How to use:

• 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 approx. 2 minutes, e.g. in hemodialysis patients via the arteriovenous fistula at the end of dialysis.


• For nonhemodialyzed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins.

Treatment with Recormon is divided into two stages:

1. 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 per week if the increase of packed cell volume is not adequate (< 0.5% 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.

2. Maintenance phase

• To maintain a packed cell volume of between 30 and 35%, the dosage is initially reduced to half of the previously administered amount. Subsequently, the dose is adjusted at intervals of one or two weeks individually for the patient (maintenance dose).


• In the case of subcutaneous administration, the weekly dose can be given as one injection per week or in divided doses three or seven times per week.


• Prevention of anemia of prematurity:


• The solution is administered subcutaneously at a dose of 3 x 250 IU/kg body weight per week. Recormon treatment should start as early as possible, preferably by day 3 of life.


• The treatment should last for 6 weeks.


• Treatment of patients with solid tumours


• The solution is administered subcutaneously; the weekly dose can be divided into 3 to 7 single doses.


• Treatment with Recormon is indicated if the hemoglobin value is ≤ 13 g/dl at the start of chemotherapy.


• The recommended initial dose is 450 IU/kg body weight per week. If, after 4 weeks, a patient does not show a satisfactory response in terms of hemoglobin values, then the dose should be doubled. The therapy should be continued for up to 3 weeks after the end of chemotherapy.


• If hemoglobin increases by more than 2 g/dl/month, the Recormon dose should first be reduced by 50%. If values exceed 14 g/dl therapy with Recormon should be interrupted until a value ≤ 12 g/dl is achieved and then restarted with 50% of the previous weekly dose.


• Treatment of patients with multiple myeloma, lowgrade nonHodgkin’s lymphoma or chronic lymphocytic leukemia


• The solution is administered subcutaneously; the weekly dose can be given as one injection per week or in divided doses 3 to7 times per week.


• The recommended initial dose is 450 IU/kg body weight per week. If, after 4 weeks of therapy, the hemoglobin value has increased by at least 1g/dl, the current dose should be continued. If the hemoglobin value has not increased by at least 1 g/dl, a dose increase to 900 IU/kg body weight, given in divided doses 2 to 7 times per week, may be considered. If, after 8 weeks of therapy, the hemoglobin value has not increased by at least 1 g/dl, response is unlikely and treatment should be discontinued.


• The maximum dose should not exceed 900 IU/kg body weight per week.


• If hemoglobin increases by more than 2 g/dl within 4 weeks, the Recormon dose should be halved. If


• hemoglobin value exceeds 14g/dl, Recormon therapy should be interrupted until a value of ≤13 g/dl is achieved; therapy should then be restarted at 50 % of the previous weekly dose.


• Treatment for increasing the amount of autologous blood:


• The solution is administered intravenously over approx. 2 minutes or subcutaneously.


• Recormon is administered twice weekly over 4 weeks.


• During the entire treatment period, a packed cell volume of 48% should not be exceeded.

Caution & Warnings:

Do not use Recormon in the following case(s)

• If you are hypersensitive (allergic) to epoetin beta or any of the other ingredients of Recormon.


• If your blood pressure is poorly controllable.


• If it is planned that you use Recormon in the indication “increasing the yield of autologous blood” and you have suffered a myocardial infarction or stroke in the month preceding treatment, you have unstable angina pectoris or you are at risk of deep venous thrombosis (e.g. if you have a history of venous thromboembolic disease).

Precautions:

• Recormon should be used with caution in the presence of refractory anemia with excess blasts in transformation, epilepsy, increased platelet count, and chronic liver failure. Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of Recormon.


• Patients who have developed antierythropoietin antibodies and pure red cell aplasia under treatment with another erythropoietic substance should not be switched to Recormon due to possible cross‑reactivity of antibodies to all erythropoietic substances.


• In chronic renal failure patients, there may be a moderate dose‑dependent rise in the platelet count within the normal range during treatment with Recormon, especially after intravenous administration. It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy.


• In premature infants there may be a slight rise in platelet counts, particularly up to day 12 ‑ 14 of life, therefore platelets should be monitored regularly.


• If there is an increase in platelets above the normal range, treatment with Recormon should be discontinued.


• In chronic renal failure patients, an increase in heparin dose during hemodialysis is frequently required during the course of therapy with Recormon as a result of the increased packed cell volume. Occlusion of the dialysis system is possible if heparinization is not optimum.


• Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis.


• Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of Recormon.


• Serum potassium levels should be monitored regularly during Recormon therapy. If an elevated or rising potassium level is observed, then consideration should be given to ceasing Recormon administration until the level has been corrected.

Ingredients:

• Active ingredient: epoetin beta.


• Excipients: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, sodium monohydrogen phosphate, calcium chloride, glycine, leucine, isoleucine, threonine, glutamic acid, and phenylalanine.


• 1 prefilled syringe contains 4000 IU epoetin beta in 0.3 ml water for injections as a solution for injection.