Testosterone cypionate side effects – highly purified non-glycosylated protein consisting of 175 amino acids. It is produced strain K12 Escherichia coli, in which the gene introduced by genetic engineering techniques gene granulocyte colony stimulating factor (G-CSF), human.
Glycoprotein that regulates the formation of functionally active neutrophils and their exit into the blood from bone marrow. In patients with severe chronic neutropenia may cause a slight increase in the number of circulating eosinophils and basophils. Some of these patients before the therapy can be detected eosinophilia or basophilia.
Neupogen ® dose-dependently increases the number of neutrophils to normal or increased functional activity, as revealed by determining phagocytic and chemotactic activity of neutrophils. After the treatment, the number of neutrophils in the peripheral blood is reduced by 50% within 1-2 days and returned to normal levels over the next 1-7 days.
Significantly reduces the frequency, severity and duration of neutropenia and febrile neutropenia, reducing the need for and duration of inpatient treatment in patients receiving chemotherapy with cytostatics or myeloablative therapy followed by bone marrow transplantation.
Patients receiving and cytotoxic chemotherapy, require lower doses of antibiotics compared to patients receiving cytotoxic chemotherapy only.
Treatment with significantly reduces the duration of febrile neutropenia, the need for antibiotic treatment and hospitalization after induction chemotherapy for acute myeloid leukemia, without affecting the frequency of fever and infection.
The use both independently and after chemotherapy, mobilizes hematopoietic stem cell yield in peripheral blood flow. Transplantation of autologous peripheral blood stem cells (PBSC) is carried out after the treatment with high doses of cytotoxic drugs or bone marrow transplantation, instead of, or in addition thereto. PBSC transplantation can also be administered after (high) myelosuppressive cytotoxic therapy. The use of PBSC mobilized using, accelerates restoration of hematopoiesis, reduces the risk of haemorrhagic complications and the need for platelet transfusions. In children and adults with TXH (severe congenital, periodic, idiopathic neutropenia) consistently increases the number of neutrophils in the peripheral blood, reduces the incidence of infectious complications.
Appointment of the drug in patients with HIV infection allows to maintain a normal neutrophil count and follow the recommended doses of antiviral and / or other myelosuppressive therapy. Signs of increased HIV replication when using the drug Neupogen ® has been noted.
As with other hematopoietic growth factors G-CSF stimulated human endothelial cells testosterone cypionate side effects in vitro.
Preclinical safety data
The carcinogenic properties of filgrastim have not been studied. Filgrastim did not induce mutations in the genomes of bacteria, regardless of whether the enzyme system necessary for the metabolism of the drug.
It has been found that certain malignant cells have receptors on their surfaces to G-CSF. The probability that filgrastim may be a growth factor for any type of tumor can not be excluded.
In studies in rats of both sexes were not observed any influence on the course of pregnancy and fertility when used filgrastim at doses up to 500 mg / kg.
In studies on rats and rabbits filgrastim did not have a teratogenic effect. In rabbits, there was an increased incidence of miscarriage, but fetal abnormalities were noted.
After subcutaneous (s / c) introduction of filgrastim is rapidly absorbed, and in 2-8 hours, reaches its maximum serum concentration. The half-life after intravenous (i / v), or s / c administration is typically from 2 to 4 hours. The clearance and half-life are dependent on the dose and the number of neutrophils. Given the dependence of the clearance of the number of neutrophils, its saturation with increasing concentration of filgrastim and reducing neutropenia, can talk about the predominance of the linear nature of the clearance and the linear nature of pharmacokinetics. The testosterone cypionate side effects absolute bioavailability after s / to the introduction of 62% at a dose of 375 mg and 72% at a dose of 750 micrograms. Filgrastim after cessation of the concentration decreases to values endogenous values within 24 hours.
In healthy volunteers and patients with cancer before chemotherapy has been shown to decrease the plasma concentrations of filgrastim in its repeated administration. The increase in clearance of filgrastim in this case is dose-dependent, and the extent of this increase may depend on the degree of neutrophilia in the recipients, which is consistent with an increase in neytrofilzavisimogo clearance with an increase in neutrophil pool. Patients receiving filgrastim after chemotherapy, the concentration of drug in plasma remained at the same level until the beginning of the recovery of hematopoiesis.
The on / and s / c administration of filgrastim observed a positive linear relationship between the administered dose and the serum concentration. After p / administration of therapeutic doses of its concentration above 10 ng / ml for 8-16 hours. The volume of distribution is 150 ml / kg.
Long-term appointment of filgrastim (up to 28 days) after autologous bone marrow transplantation does not lead to accumulation and the change in half-life.
Regardless of the route of administration, the elimination of filgrastim takes place according to the rules of the kinetics of the 1st order. The half – 3.5 hours, a clearance is 0.6 ml / min / kg.
Pharmacokinetics in special patient groups
have children after chemotherapy pharmacokinetics of filgrastim is similar to that in adult patients receiving a given weight the same dose that leads to the conclusion independence pharmacokinetics of filgrastim on age.
Pharmacokinetic data from over 65 years are no patients.
The instructions for testosterone cypionate side effects use filgrastim studies have shown that the pharmacokinetics and pharmacodynamics in patients with severe renal or hepatic functions similar to those in healthy subjects. Therefore, in these cases, the need for dose adjustment is absent.
In patients with end-stage renal failure showed a trend toward an increase in systemic exposure of filgrastim in comparison with healthy volunteers and patients with creatinine clearance 30-60 ml / min.