Cinnapoietin®

Description

Cinnapoietin^® is a is a sterile, purified, stable recombinant human erythropoietin concentrate produced from genetically engineered Chinese hamster ovary (CHO) cells containing a cloned human erythropoietin gene, produced under EU GMP license. Dosage Forms and Strengths of Cinnapoietin^® are 2000 IU, 4000 IU,10000 IU, 20000 IU and 40000 IU epoetin beta in prefilled syringes, which can be administrated by Intravenous or subcutaneous injection.

Indications

Cinnapoietin^® is indicated;

• for the treatment of anemia associated with chronic kidney disease (CKD) in patients on dialysis and symptomatic patients not yet undergoing dialysis,
• to increase the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood,
• for the prevention of anemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks,
• for the treatment of anemia and reduction of transfusion requirements in patients with non-myeloid malignancies, where anemia develops as a result of concomitantly administered chemotherapy

Important safety information

• In the indication "increasing the yield of autologous blood" Cinnapoietin^® 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 risk of deep venous thrombosis such as those with a history of venous thromboembolic disease.

• Cardiovascular and thrombotic events such as myocardial ischaemia and infarction, cerebrovascular haemorrhage and infarction, transient ischaemic attacks, deep venous thrombosis, arterial thrombosis, pulmonary emboli, retinal thrombosis and haemodialysis graft occlusion have been reported in patients receiving Erythropoiesis Stimulating Agents (ESAs).  To reduce cardiovascular risks, use the lowest dose of Cinnapoietin^® that will gradually increase the haemoglobin concentration. The haemoglobin concentration should not exceed 120g/L and the rate of haemoglobin increase should not exceed 10 g/L in a 2-week period. Haemoglobin levels should be checked at regular intervals and dosages adjusted.
• Cinnapoietin^®, like other ESAs, could act as a growth factor for any type of malignancy. ESAs, when administered to target haemoglobin of > 120 g/L, shortened the time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy. ESAs also shortened survival in patients with metastatic breast cancer receiving chemotherapy when administered to a target haemoglobin of > 120 g/L.
• Cinnapoietin^® should only be used to treat cancer patients with anemia where the anemia has arisen as a result of concomitantly administered chemotherapy.
• Patients with uncontrolled hypertension should not be treated with Cinnapoietin^®; blood pressure should be controlled adequately before initiation of therapy.
• PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with ESA therapy. patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to Cinnapoietin^®. If anti-erythropoietin antibody-mediated PRCA develops whilst on Cinnapoietin^®, therapy with Cinnapoietin^® must be discontinued and patients should not be switched to another ESA.
• ESAs should be used with caution in patients with epilepsy. Convulsions have been reported in patients with CKD receiving Cinnapoietin^®. 
• Cinnapoietin^® should be used with caution in the presence of refractory anemia with excess blasts in transformation, thrombocytosis, and chronic liver failure. 
• Anaphylactoid reactions have been observed in isolated cases. Rarely, skin reactions such as rash, pruritus, urticaria or injection site reactions may occur, however in controlled clinical studies, no increased incidences of hypersensitivity reactions were found. It is recommended that the first dose be administered under medical supervision.
• The indication of nephrosclerotic patients not yet undergoing dialysis should be defined individually as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
• In dialysis patients, an increase in heparin dose is frequently required during the course of Cinnapoietin^® therapy as a result of increased haemoglobin. Occlusion of the dialysis system is possible if heparinisation is not optimum.