Eporen™

Erythropoietin BP
Erythropoiesis-Stimulating Agent (Erythropoiesis-Stimulating Agent)

Indication:

Anemia associated with-
Chronic Kidney Disease (With or without dialysis),
Cancer Chemotherapy,
Blood loss due to trauma or surgery,
Zidovudine treatment in HIV infected patients

Dosage & Administration:

Treatment of anemia in chronic renal failure

Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33 -36 % in adults.
Starting dose:

Adult: usually 50 to 100 IU/kg three times in a week (TIW) by IV or Subcutaneous route
Pediatric: 50 IU/kg TIW by IV or Subcutaneous route
Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.
Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 IU/kg TIW, with a range from 12.5 to 525 IU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 IU/kg/week.

Treatment of Anemia in Cancer Patients on Chemotherapy

Starting dose:
Adult: 150 IU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly
Pediatric: 25 to 300 IU/kg 3 to 7 times per week by Subcutaneous or IV route
Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 IU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%. The dose should be redirced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.

Surgery Patients

The recommended dose is 300 IU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 IU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Zidovudine-treated HIV-infected Patients

Starting dose:

Adult: 100 IU/kg as an IV or Subcutaneous injection TIW for 8 weeks
Pediatric: 50 to 400 IU/kg 2 to 3 times per week by Subcutaneous or IV route
Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-100 I U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 IU/kg increments TIW.
Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.

Administration

Do not shake. It is not necessary to shake Eporen. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Administer as intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
Do not administer by intravenous infusion or in conjunction with other drug solutions.
For the subcutaneous route, a maximum of 1 mL at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.

Preparation:

Eporen™ 5000 IU: Each box contains 1 Pre-filled syringe containing 5000 IU of Erythropoietin Concentrated Solution.