Recormon 4000 IU epoetin beta pre‑filled Syringes × 6 (refrigerated)

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.

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.