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RXDRUG-BR-754

EPOSINO Epoetin Alfa 6,000IU / mL Solution for IV/SC Injection 1mL 1's

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Description

Indications/Uses

Treatment of anemia, especially in renal anemia resulting from renal function insufficiency, including hemodialysis and non-hemodialysis of chronic renal failure.
 

Dosage/Direction for Use

Eposino should be administered through SC and IV 2-3 times/week under physician's direction. Dosage can be changed according to anemia status, age and other related factors of 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/week. If hematocrit increase is not as expected (<0.5 vol/week), the dosage can be changed after 4 weeks of initial treatment to increase the dose to 15-30 iu/kg/week but not more than 30 iu/kg/week. The expected rise of hematocrit should be in range of 30-33% v/v, not higher than 34% v/v.
Maintenance Period: If the hematocrit has reached to 30-33% v/v and/or the hemoglobin has reached 100-110 g/L, the maintenance treatment starts. The dosage should be 2/3 of the initial dosage on this stage. The hematocrit should be 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 erythropoiesis to be formed too quickly. Eposino is usually for long-term use, however, the therapy with Eposino might be stopped for special cases.
 

Contraindications

Patients with uncontrollable severe hypertension; those allergic to epoetin α or to other erythropoietin agents. Those with combined infections should be cured before Eposino is administered.
 

Special Precautions

During the treatment with epoetin α, the hematocrit should be checked regularly (once a week at the early stage and once every 2 weeks in the maintenance period). The hematocrit should be maintained <30% volume to avoid the formation of extraordinary erythropoiesis. Should extraordinary erythropoiesis happen, suitable treatment shall be taken eg, temporarily discontinuing the use of epoetin α.
Hyperkalemia may appear during the course of treatment, diet should be adjusted or the Eposino should be stopped for use when hyperkalemia occurs until the normal level is recovered.
Eposino should be used carefully for patients with myocardial infarction or to pulmonary infarction or those with allergic history or tendency.
During the treatment with recombinant human erythropoietin α, iron concentration in serum usually decreases. Therefore, it is necessary to provide iron to meet the body's need. If serum ferric concentration is <100 mg/mL or the transfer in saturation falls <20%, daily ferrotherapy should be adopted.
Folic and vitamin B12 insufficiency and ultra-high aluminum may reduce efficacy or Eposino.
Use in Pregnancy & Lactation: The safety for pregnant women or in lactation is not certain.
Use in Children: The safety for children is not certain.
Use in Elderly: For aged patients with complications of hypertension or circulation system because of hypo-function, the blood pressure and hematocrit should be monitored frequently when epoetin α is used. The dosage and times of administration should be adjusted accordingly.
 

Use In Pregnancy & Lactation

The safety for pregnant women or in lactation is not certain.
 

Adverse Reactions

Common: A few may have headache, low fever and fatigue, muscle pain and arthralgia at the initial state of drug administration. But most of the adverse reactions may be relieved upon duration of treatment accordingly and there is no need to discontinue the use of Eposino. If the previously-mentioned symptoms still exist, discontinuance of the drug may be considered.
Allergic Reactions: Allergic reactions eg, skin rashes or urticaria, including allergic shock may occur rarely, therefore, it is advised that a small dosage of Eposino should be used as an initial dose as well as in the beginning of reuse of Eposino, make sure that there are no abnormal reactions that occur before the use of full dose as prescribed. If they do occur, Eposino 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 eg, headache, disturbance of consciousness, convulsion and sometimes even encephalorrhagia. Therefore, blood pressure should be monitored periodically, dosage may be decreased or stopped and the depressor drug may also be adjusted.
Hematological System: The blood viscosity may increase as hematocrit rises. For some patients receiving hemodialysis, the heparin dosage should be increased whenever necessary to prevent artificial renal hemoagglutination. Accordingly, 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 may sometimes rise.
Gastrointestinal System: Nausea, vomiting, anorexia and diarrhea may happen occasionally when Eposino is used.
 

Drug Interactions

Folic & vit B12 insufficiency, ultra-high Al.
 

Storage

Store at 2-8°C. Protect from light. Do not freeze nor shake.
Shelf-Life: 2 years.
 

MedsGo Class

Haematopoietic Agents

Features

Brand
Eposino
Full Details
Dosage Strength
6,000 IU / ml
Drug Ingredients
  • Epoetin Alfa
Drug Packaging
Solution for Injection (I.V./S.C.) 1ml x 1's
Generic Name
Epoetin alfa
Dosage Form
Solution For Injection (I.V./S.C.)
Registration Number
BR-754
Drug Classification
Prescription Drug (RX)
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