EPOSINO (Epoetin ALFA)Solution for Injection
Each milliliter of Epoetin Alfa (Eposino) contains
Recombinant Human Erythropoietin - 10,000 IU / 6,000 IU / 4,000 IU / 2,000 IU
This product is colorless and transparent liquid.
For the treatment of anemia, especially in renal anemia resulting from renal function insufficiency, including hemodialysis and non-hemodialysis of chronic renal failure.
Dosage and Administration
This product should be administered through subcutaneous or intravenous route 2-3 times per week under physicians' direction. Dosage can be changed according to anemia status, age and other related factors of the patients.
The initial dosage for the patients receiving hemodialysis is 100-150 IU/Kg, and for those not on hemodialysis is 75-100 IU/Kg per week. If hematocrit increase is not as expected (<0.5vol/week), the dosage can be changed after 4 weeks of initial treatment to increase the dose 15-30 IU/Kg per week, but not more than 30 IU/Kg per week. The expected rise of hematocrit should be in range of 30-33v/v%, not higher than 34v/v%.
If the hematocrit has reached to 30-33vol% and or the hemoglobin has reached to 100-110g/L, the maintenance treatment starts. The dosage should be 2/3 of the initial dosage on this stage. The hematocrit should b monitored once every 2-4 weeks so as to adjust the dosage to maintain hematocrit and hemoglobin at the proper level as well as to avoid erythropoesis to be formed too quickly. Eposino usually is a long term used, however, the therapy with this drug might be stopped for special cases.
10000 IU / 6,000IU / 4,000 IU / 2,000 IU per mL pre-filled syringe.
Store at 2-8 degrees Celsius, protect from light and do not freeze and shake.
Product is stable for two years
BFAD Drug Approval
10,000 IU - DR-XY31384 / 6,000 IU - 32891 / 4,000 IU - 32889 / 2,000 IU - 32890
Foods, Drugs, Devices and Cosmetics Act prohibit dispensing without prescription.
Patients with uncontrollable severe hypertension
Those allergic to this product or to other erythropoietin agents
Those with combined infections, which should be cured before the product is administered.
Common Side Effects
A few may have headache, low fever and fatigue and only few may have muscle pain and arthralgia at the initial state of drug administration. But most of the side reactions may be relieved upon the treatment accordingly and no need to discontinue the use of the drug. If the above-mentioned symptoms still exist, stoppage of use of the drug may be considered.
Allergic reactions such as skin rashes or uticaria, including allergic shock may occur rarely, therefore, it is a advised that a small dosage of the drug should be used as an initial dose as well as in the beginning of reuse of the drug, make sure no abnormal reactions occur before the use of full dose as prescribed. If it does occur, the drug should be stopped immediately and the proper treatment provided.
Hypertension or other symptoms caused by the exacerbation of existing hypertension and hypertensive encephalopathy may occur such as headache, disturbance of consciousness, convulsion and sometimes even encephalorrhagia. Therefore, blood pressure should be monitored periodically, the drug dosage may be decreased or stopped, and the depressor drug may also be adjusted.
The blood viscosity may increase obviously as hematocrit rises. For some patients receiving hemodialysis, the heparin dosage should be increased whenever necessary to prevent artificial renal hemo-agglutination. Additionally, patients who tend to have hypotension or suffer from artriovenous fistulae occlusion, should use acetylsalicylic acid or aspirin to prevent the hemo-occlusion.
Hepatic function impairment may occur, GOP and GPT sometimes may rise up.
Nausea, vomiting, anorexia and diarrhea may happen occasionally when the drug is used.
Shandong Kexing Bioproducts Co., Ltd.
Tangwangshan Road, MingShui Development Zone
ZhangQiu, Jinan-250200, China
Exclusively Imported By
Goodfellow Pharma Corporation
Unit 3009 Jollibee Plaza Bldg., Emerald Ave.,
Ortigas Center, Pasig City
Tel. Nos.: (632) 632-7031
Fax: (632) 635-3957
Copyright © 2008 Goodfellow Pharma Corporation
Unit 3009 Jollibee Plaza Bldg.,
Emerald Ave., Ortigas Center 1605 Pasig City
Telephone: (+632) 635-3957 / 632-7031
Mobile No.: (0917) 831-1338