【Specifications】1500IU, 2000IU, 3000IU, 4000IU, 6000IU, 10000IU
【Packing】Vial/Prefilled Syringe
【Generic Name】Recombinant Human Erythropoietin Injection (rhEPO)
【Description】GerEpo is extracted from Chinese hamster ovary(CHO) cell cultures into which the human erythropoietin gene has been introduced by recombinant DNA technology. GerEpo, a 165 amino acid glycoprotein, has a molecular weight of about 34KD. It has the same physiological functions as natural human erythropoietin, and can stimulate the differentiation and multiplication of committed erythroic progenitors in the bone marrow.
【Characters】A clear and colorless solution, pH 6.4-7.4
【Composition】Each single-use vial consists of Recombinant Human Erythropoietin (rhEPO), albumin activated stabilizer and buffer saline solution, etc.
【Indications】GerEpo is indicated in the treatment of anemia caused by renal insufficiency, including patients on dialysis and non-dialysis.
【Usage and Dosage】GerEpo should be administered under the direction of doctors. It may be given either subcutaneously or intravenously 2-3 times a week. The dose adjustment will depend on anemic conditions of the patients, the age and other related factors. The reference dosage is as follows:
Therapeutic Dose: In patients on dialysis, GerEpo is administered initially in usual doses of 100-150 IU/kg weekly. Starting doses over the range of 75-100 IU/kg may be given to patients not requiring dialysis. If the increase in hematocrit is less than 0.5wol% weekly, the dosage can be increased after four weeks by 15-30IU/kg, but should not exceed 30IU/kg. Hematocrit should be increased up to 30-33 vol%, but should not exceed 34 vol%.
Maintenance Dose: When the hematocrit reaches 30-33 vol% or the hemoglobin comes to 100-110g/ml, the maintenance stage will begin. A recommended maintenance dose is equal to two thirds of the therapeutic dose. The hematocrit should be measured once every 2-4weeks in order to adjust the dose. Such adjustment can avoid red blood cell production at an excessive rate, and maintain adequate level of hematocrit and hemoglobin.
In patients on dialysis, GerEpo is usually administered by intravenous injection. For patients on peritoneal dialysis, it is better that GerEpo is given subcutaneously. Both intravenous and subcutaneous injections are feasible to the patients not requiring dialysis.
【Adverse Effects】Since GerEpo is well-tolerated, the adverse effects are mild.
1. Common Reactions: In a small number of patients, headache, lower fever and acratia may occur during the early phase of treatment. Myalgia and arthragin may be seen in a few patients. The most adverse reactions can take a favorable turn after expectant treatments, thus GerEpo continuous administration can not be affected. If the above-mentioned symptoms are still in existence in very few patients, GerEpo should be withheld.
2. Allergic reactions: Allergic reactions are associated with GerEpo administered in a few patients, such as skin rashes, urticaria and anaphylactic shock. Therefore, it is recommended that the initial dose of GerEpo should be injected in small amounts. Full dosage can be given after no abnormal reactions are to be confirmed. If an abnormal reaction occurs, GerEpo should be immediately discontinued and appropriate therapy initiated.
3. Cardiovascular System: Blood pressure may rise in a few patients. For this reason, blood pressure in GerEpo treated patients should be monitored at regular intervals. If needed, the dose of GerEpo should be reduced or withheld. Care should be taken to adjust the administration of hypotensors.
4. Blood System: With an increase in hematocrit, blood viscosity may rise significantly, so it is necessary to prevent thrombosis.
5. Hepatic System: Hepatic disturbance may occur in rare cases, such as GOT and GPT increment.
6. Gastrointestinal System: Nausea, vomiting, anorexia and diarrhea may occur occasionally during GerEpo therapy.
【Contraindications】GerEpo is contraindicated in patients with:
1. uncontrolled hypertension
2. unknown hypersensitivity to mammalian cell-derived products
3. known hypersensitivity to human serum albumin
【Precautions】
1. The hematocrit should be controlled periodically during GerEpo therapy (once a week during the early phase of treatment, twice a week during the maintenance phase). Care needs to be taken to avoid red blood cell production at an excessive rate (the hematocrit should be confirmed below 34 vol%). If it is found that red blood cells produce too rapidly, GerEpo should be temporarily withheld.
2. As hyperkalemia may be associated with GerEpo during treatment, it is necessary to regulate diet of patients appropriately. If hyperkalemia occurs, GerEpo should be withheld until blood potassium returns to normal level.
3. GerEpo should be used with caution in patients with cardiac, pulmonary or cerebral infraction, a known history of drug allergy, or in patients with allergic trend.
4. When the aged patients are treated with the product, hypertension and diseases with circular system may mostly occur due to the insufficient physiological functions. In this case, the blood pressure and hematocrit should be frequently monitored and the dose and frequency of administration should be properly adjusted.
5. During the treatment, effective erythropoiesis may cause an increasing demand for iron and the concentration of serum iron often decreases. If patients’ serum ferritin is lower than 100ng/ml or the saturation level of ferrite is lower than 20%, the supplement with ferralium should be required every day.
6. The safety of GerEpo to pregnant women, nursing mothers and children has not been established.
7. The efficacy of GerEpo therapy may be reduced due to folic acid and vitamin B12 deficiencies. And the curative effect of GerEpo may be affected by serious excessive aluminum.
【Administration of GerEpo】Using aseptic techniques, attach a sterile needle to a sterile syringe. Open the vial and insert the needle into the vial, and withdraw into the syringe an appropriate volume of solution. GerEpo may be given as an intravenous or subcutaneous injection. If GerEpo is packed with a prefilling syringe, remove the rubber stopper and inject directly into patients by intravenous or subcutaneous administration.
【Storage】Stored and transported at 2℃ to 8℃(36℉to 48℉). Do not freeze or shake. Avoid heating.
【Terms of Validity】2 years
【manufacturer】NCPC GeneTech Biotechnology Development Co., Ltd
【Exporter】North China Pharmaceutical Group Corp. Import & Export Co., Ltd.