Oncology Division
HENPLATIN (Oxaliplatin) HENTAXEL (Docetaxel) TPIAO (Thrombopoietin) ZEFEI (Gemcitabine) ZILONGJIN (Astragalus) HENSETRON (Tropisetron HCl)
Hematology Division
EPOSINO (Epoetin Alfa) FERROFER (Iron Sucrose) TPIAO (Thrombopoietin) WHITE-C (Filgrastim)
Nephrology Division
EPOSINO (Epoetin Alfa) FERROFER (Iron Sucrose)
GoodFellow Pharma Corporation

EPOSINO (Epoetin ALFA)

Solution for Injection
Formulation
Each milliliter of Epoetin Alfa (Eposino) contains

Active Ingredient
Recombinant Human Erythropoietin - 10,000 IU / 6,000 IU / 4,000 IU / 2,000 IU

Other Ingredients
Albumin.....................................2.5mg
Sterile Sodium Citrate..................5.882mg
Sterile Citric Acid........................0.063mg
Sterile Sodium Chloride.................5.884mg

Appearance
This product is colorless and transparent liquid.



Indication
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.

Treatment Period
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%.

Maintenance Period
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.

Availability
10000 IU / 6,000IU / 4,000 IU / 2,000 IU per mL pre-filled syringe.

Storage
Store at 2-8 degrees Celsius, protect from light and do not freeze and shake.

Shelf-Life
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

Caution
Foods, Drugs, Devices and Cosmetics Act prohibit dispensing without prescription.

Contraindications
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
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.

Cardiovascular System
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.

Hematological System
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.

Liver
Hepatic function impairment may occur, GOP and GPT sometimes may rise up.

Gastrointestinal System
Nausea, vomiting, anorexia and diarrhea may happen occasionally when the drug is used.

Precautions
  • During the treatment with Epoetin Alfa, the hematocrit should be checked regularly ( once a week at the early stage and once every two weeks in the maintenance period). The hematocrit should be maintained under 30vol/% to avoid the formation of extraordinary erythropoiesis. Should extraordinary erythropoiesis happen, suitable treatment shall be taken such as temporary stopping use of Epoetin Alfa.
  • Hyperkalemia may appear during the course of treatment, diet should be adjusted or the drug should be stopped for use when hyperkalemia occurs until the normal level is recovered.
  • The drug should be used carefully for the patients with myocardial infarction or to pulmonary infarction or those with allergic history or tendency.
  • For aged patients with complications of hypertension or circulation system disease because of hypo-function, when Epoetin Alfa is used, the blood pressure and hematocrit should be monitored frequently, and the dosage and times of administration should be adjusted accordingly.
  • During the treatment with Recombinant Human Erythropoietin Alfa, iron concentration in serum usually decreases. Therefore, it is necessary to provide iron to meet the body need. If serum ferric concentration is less than 100mg/mL or the transfer in saturation falls below 20%, daily ferrotherapy should be adopted.
  • The safety for children and pregnant women or in lactation is not certain.
  • Folic and Vitamin B12 insufficiency and ultra-high aluminum may reduce efficacy of EPOSINO.


Manufactured By
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
E-mail: good_fellow88@yahoo.com
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

e-mail: good_fellow88@yahoo.com