At the introduction of philgrastime in/in and p/k a positive linear dependence of its serum concentration on the dose was observed. The volume of distribution is approximately 150 ml/kg. Both after philgrastime administration and after philgrastime administration are eliminated from the body in accordance with 1st order kinetics. The average T1/2 value of serum filgrastima from both healthy and tumour patients is about 3.5 h; the clearance rate is about 0.5-0.7 ml/min/kg. With continuous 24-hour philgrastima infusions at a dose of 20 µg/kg for 11-20 days, an equilibrium concentration is achieved in the blood without signs of cumulation during the observed period.
Application of Filgrastim substance
Neutropenia (including in patients receiving cytostatic drugs due to non-myeloid malignancies); reduction of neutropenia period and its clinical consequences in patients preparing for bone marrow transplantation; persistent neutropenia in patients with advanced stage of HIV infection (absolute neutrophil number 1000 cells/μL and less); peripheral stem cell mobilization (in tonnes of neutropenia).after myelosuppressive therapy); https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5184lbl.pdf neutropenia (hereditary, periodic or idiopathic – neutrophil number is lower or equal to 500 cells/µl) and severe or recurrent infections (in history) during the last 12 months.
Hypersensitivity, severe congenital neutropenia in abnormal cytogenetics (Costmann’s syndrome), increased doses of cytotoxic chemotherapeutic agents above the recommended ones, hepatic and/or renal failure, age up to 1 year.
Restrictions on use
Malignant and pre-tumor diseases of myeloid nature, combination with high-dose therapy.
Use in pregnancy and breastfeeding
During pregnancy it is possible if the expected effect of therapy exceeds the potential risk to the fetus (no adequate and strictly controlled trials have been conducted, safety for pregnant women has not been established).
Studies on rabbits have shown that filgrastimum causes side effects in pregnant rabbits when taken at doses 2-10 times higher than the human dose. When filgrastim was administered to rabbits at doses of 80 µg/kg/day, an increased rate of miscarriage and embryo mortality was observed. Filgrastim administered to pregnant rabbits at doses of 80 µg/kg/day during organogenesis resulted in urogenital bleeding, reduced food intake, increased foetal resorption, abnormal development, reduced body weight, number of viable cubs. External anomalies were not observed in fetuses of females who received doses of 80 µg/kg/day.
Studies in pregnant rats with daily Filgrastim overdose injections during organogenesis at doses up to 575 µg/kg/day showed no signs of lethality, teratogenicity or behavioural effects in the offspring.