Mielastra® can be administered by daily subcutaneous (SC) injection or daily short (30-minute) intravenous (IV) infusion. Also, the drug can be administered in the form of 24-hour intravenous or subcutaneous infusions.
The choice of route of administration should depend on the specific clinical situation, however, in most cases, the subcutaneous route of administration is preferred.
To avoid pain, with the introduction of the best time to change the injection site daily.
Standard schemes of cytotoxic chemotherapy
For 0.5 million ME (5 μg) / kg of body weight, once a day, subcutaneously or intravenously drip for 30 minutes, until, after the expected decrease in the level of neutrophils, their number is restored to normal, at which achievement the drug can be canceled.
The first dose of myelastra® should be administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy. Duration of therapy up to 14 days. After induction and consolidation therapy of acute myelogenous leukemia, the duration of application of myelastra® may increase to 38 days, depending on the type, dosage and chemotherapy scheme used.
Usually a transient increase in the number of neutrophils is observed 1-2 days after the initiation of treatment with filgrastim. To achieve a stable therapeutic effect, it is not recommended to interrupt treatment until normal neutrophil values are reached after the expected maximum decrease in their level. With an absolute number of neutrophils in excess of 10,000 / μL, treatment with MIELASTRO® terminate.
Myeloablative therapy followed by autologous or allogeneic bone marrow transplantation
The initial dose is 1 million IU / kg (10 μg) per day IV in the drip for 30 minutes or 24 hours, or as a 24-hour infusion.
The first dose of myelastra® should be administered no earlier than 24 hours after the chemotherapy and no later than 24 hours after bone marrow transplantation. The duration of therapy is no more than 28 days. The daily dose of the drug is corrected depending on the dynamics of the neutrophil content. With an absolute number of neutrophils greater than 1000 / μL for three consecutive days, the dose of Myelastra® reduce to 0.5 million IU / kg / day. If, during the application of this dose, for an additional 3 consecutive days, the absolute number of neutrophils exceeds 1000 / μL, the introduction of the Myelastra® terminate. If, during treatment, the absolute amount of neutrophils decreases to less than 1000 / μl, the dose of Myelastra® increase again, in accordance with the above scheme.
Mobilization of peripheral blood stem cells (PSSC) in painwith neoplastic diseases
For 1 million IU / kg once a day, or by continuous 24-hour infusion for 6 consecutive days.In this case, usually 2 leukapheresis is performed in a row, on the 5th and 6th days. In the case of additional leukapheresis, the introduction of the Myelastra® should continue until the last leukapheresis.
Mobilization of PSKC after myelosuppressive chemotherapy
For 0.5 million IU / kg per day by daily subcutaneous injections, starting from the first day after completion of chemotherapy and until the number of neutrophils reaches normal values. Leukapheresis should be performed only when the absolute number of neutrophils exceeds normal values (> 2000 / μl).
Mobilization of PSKC in healthy donors for allogeneic transplantation
The use of filgrastim 1 million IU / kg / day for 4-5 days and 1 or 2 leukapheresis usually allows for more than 4 x 106 Cd34+ cells / kg body weight of the recipient. Data on the safety and efficacy of filgrastim in healthy donors under the age of 16 and older than 60 years are not available.
Severe chronic neutropenia (THC)
Myelastra® is administered at an initial dose of 1.2 million IU / kg / day for congenital neutropenia and 0.5 million IU / kg / day for idiopathic or intermittent neutropenia subcutaneously single or by several administrations daily until the number of neutrophils is consistently higher 1500 / μL.Once the therapeutic effect is achieved, the minimum effective dose is determined to maintain this level. After 1-2 weeks of treatment, the initial dose can be doubled or halved, depending on the patient's response to therapy. Subsequently, every 1-2 weeks, individual dose adjustment can be performed to maintain the average number of neutrophils in the range of 1500-10000 / μL. In patients with severe infections, a scheme with a faster increase in dose can be used. The safety of filgrastim with prolonged treatment of patients with TCN doses greater than 24 μg per day is not established.
Neutropenia in HIV infection
The initial dose of 0.1-0.4 million IU / kg subcutaneously once a day until the normalization of the number of neutrophils. The maximum daily dose should not exceed 1 million IU / kg. After achieving a therapeutic effect, it is recommended to use Mielastra® in a maintenance dose: 30 million ME п / к in a day. Subsequently, the doses are corrected in each individual case separately to maintain an average number of neutrophils greater than 2000 / μL.
Children. Myelastra® is used in children in the same doses as in adults.
Elderly patients, patients with impaired renal or hepatic function. Correction of the dose of myelastra® not required.
Rules for the preparation of a solution for infusions
Mielastra® is diluted with only 5% dextrose solution. Dilution 0.9% solution of sodium chloride is not allowed (pharmaceutical incompatibility).
Filgrastim diluted in a concentration of 0.2-1.5 million IU / ml can be adsorbed by glass and plastics. In this case, to prevent absorption in the solution, add serum human albumin in the required amount to reach its concentration in the final solution of 0.2 million IU / ml. For a diluted solution of myelastra® at a concentration of more than 1.5 million IU / mL of albumin addition is not required.
To bred myelastra® to a concentration of less than 0.2 million IU / ml can not.