PDpoetin® is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology by Pooyesh Darou Biopharmaceutical Company.
PDpoetin® stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.
PDpoetin® is recombinant human erythropoietin (EPO). It is expressed in Chinese hamster ovary cells (CHO) and has a 165 amino acid sequence identical to that of human urinary EPO; the two are indistinguishable on the basis of functional assays. The apparent molecular weight of erythropoietin is about 30,400 daltons.
Indications and Clinical Use
PDpoetin® is indicated for the treatment of patients with symptomatic or transfusion requiring anemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions.
PDpoetin® is also indicated for the treatment of anemia and reduction of transfusion in patients with non-myeloid malignancies where anemia develops as a result of concomitantly administered chemotherapy
PDpoetin® is also indicated in adult patients with mild-to-moderate anemia (hemoglobin > 100 to ≤ 130 g/L) scheduled for elective surgery with an expected moderate blood loss (2 – 4 units or 900 to 1800 mL) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery.
PDpoetin® is also indicated to augment autologous blood collection and to limit the decline in hemoglobin in anemic adult patients who are scheduled for major elective surgery and who are not expected to pre-deposit their complete peri-operative blood needs.
Dosage and Administration
Adult patients scheduled for elective surgery
The recommended dose regimen is 600 IU/kg PDpoetin® given weekly for three weeks (Days -21, -14, and -7) prior to surgery and on the day of surgery
Anemic adult surgery patients in an Autologous Pre-donation Program (ABD)
The recommended dose is 300 – 600 IU/kg twice weekly for three weeks, together with at least 200 mg oral elemental iron daily.
Chronic Renal Failure Patients
Treatment with PDpoetin® is divided into two stages:
The initial dosage is 50 IU/kg body weight three times a week IV/SC. If hemoglobin does not increase by 10 g/L after 1 month of treatment, the dosage may be raised to 75 IU/kg three times per week – and if further increments are needed they should be at 25 IU/kg, three times per week, at monthly intervals, to achieve hemoglobin not to exceed 120 g/L.
The IV/SC dose has to be adjusted individually to maintain hemoglobin not to exceed 120 g/L. The maintenance dose should be individualized for each chronic renal failure patient. The recommended total weekly dose is between 75 and 300 IU/kg.
Action and Clinical Pharmacology
Mechanism of Action
Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. PDpoetin® contains the identical amino acid sequence of isolated natural erythropoietin.
Absorption: Adult And Pediatric Patients with CKD: (SQ) Tmax=5-24 hours
Anemic Cancer Patients: (SQ) Tmax=13.3 hours (150 U/kg 3X weekly), 38 hrs (40,000 U weekly). Elimination: Adult And Pediatric Patients with CKD: (IV) T1/2=4-13 hours.
Anemic Cancer Patients: (SQ) T1/2=16-67 hours.
Common side effects of PDpoetin® include:
Headache, body aches, diarrhea, irritation at the injection site, pyrexia, hypertension, vomiting, cough, rash, arthralgia, nausea
- Uncontrolled hypertension
- Known hypersensitivity to mammalian cell-derived products
- Known hypersensitivity to Albumin (Human)
PDpoetin® is available in two dosage forms of ampoule and prefilled syringe in the following strengths:
Ampoules: 2000, 4000 and 10000 IU/mL
Prefilled syringes: 2000, 4000 and 10000 IU/0.5 Ml