Epovax Mechanism of Action

Pharmacology: Pharmacodynamics: Erythropoietin (EPO) is a kind of glycoprotein secreted by kidney, which can accelerate proliferation and differentiation of erythroid hemopoietic progenitor cell of bone marrow. This drug is a preparation of recombinant human erythropoietin (rhEPO) and has similar biological activity both in vivo and in vitro compared to natural EPO. Existing studies show that this drug can increase the colony generation rate of erythroid hemopoietor progenitor cell (CFU-E).
Pharmacokinetics: Plasma concentration: Healthy adults: For healthy adults with an injection of 100 IU/Kg or 200 IU/Kg, the half-life of intravenous injection is 4.76 h or 5.01 h, while plasma concentration will reach to peak (C max) (103.6 or 242.3 mIU/mL) 12 h later for hypodermic injection, then slowly decline within 2.22 or 22.4 h of half-life. The plasma concentration of hypodermic injection is higher than that of intravenous injection 36 h later.
Patients with renal anemia before dialysis: For patients with renal anemia 12-24 h after an Hypodermic injection of 6000 IU or 9000 IU previous to dialysis, plasma concentration will reach 24.6 or 19.1 h of half-life.
Urinary excretion: For healthy adult men, 48 h after an injection of 100 IU/kg or 200 IU/kg, 1.80% or 2.13% of the dosage of intravenous injection will be excreted, while 0.15% or 1.41% of the dosage of hypodermic injection will be excreted.
Toxicology: Repeated dose toxicity: hematopoiesis hyperfunction was found for intravenous injection or intraperitoneal injection to rat for continuous 4 weeks, 13 weeks and 52 weeks with dosages higher than 80, 20 and 10 IU/Kg/day respectively, and myelofibrosis was found for long term administration. Hematopoiesis hyperfunction was found for hypodermic injection to rat born 4 days later for continuous 28 days with a dosage higher that 80 IU/Kg/day, and myelofibrosis and structural change of osteogenesis were found for a dosage of 400 IU/Kg/day. Hematopoiesis hyperfunction was found for intravenous injection to dog for continuous 4 weeks, 13 weeks, and 52 weeks with dosages higher than 200, 100 and 20 IU/Kg/day respectively, and myelofibrosis and structural change of kidney was found for long term administration.
Genetic Toxicity: All results of Ames test, mammalian chromosomal aberration test, micronucleus test and HGPRT locus gene mutation test were negative.
Reproduction toxicity: slight increase in rate of abortion was found for intravenous injection to female rat at 100 and 500 IU/Kg (5.4 and 27 fold of maximum recommended dosage, respectively, calculated on body surface area); the following were found for 500 IU/Kg group; lower increase in weight for F1 (first filial generation) fetuses. Delay in generation of ventrals, opening eyelids and ossification, and reduction in number of caudal vertebras. But no adverse reaction was found in rabbits administered with 500 IU/Kg from 8 to 18 days after becoming pregnant. There is no sufficient and strict controlled clinical study data about pregnant women. It can be used for pregnant women only when the potential benefits is more than the potential harm to fetuses. No drug related adverse reaction was found for F1 and F2 (second filial generation) fetuses when 500 IU/Kg was administered to female rat during perinatal period. It is not sure whether this drug is excreted through human milk. Pregnant women should use carefully considering that many drugs can be excreted through human milk.