Leukostim® can be administered either subcutaneously or intravenously. The mode of administration and dose depend on the specific clinical situation and are determined by the attending physician.Preferably a subcutaneous route of administration. If intravenous administration is required, the required amount of the drug is injected from the syringe into a vial or plastic container with a 5% dextrose solution, followed by a 30-minute infusion of the diluted drug. Due to the increased sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, the use of Leukostim® is not recommended less than 24 hours before the start of chemotherapy and earlier than 24 hours after the end of chemotherapy.
Dilution instructions:
Leuchkam can not be diluted with 0.9% solution of sodium chloride; the preparation is bred 5% solution of dextrose. If the drug is diluted to concentration of less than 15 μg / ml (less than 1.5 million IU / ml), then the solution should be added with whey human albumin, so that the final concentration of albumin is 2 mg / ml. For example, with a final solution volume of 20 ml, the total dose of Leucostim ® is less than 300 μg (less than 30 million) ME) should be administered with the addition of 0.2 ml of a 20% solution of human albumin. You can not breed filgrastim to a final concentration of less than 2 μg / ml (less than 0.2 million IU / ml).
Recommended doses:
For treatment neutropenia after a course of cytotoxic chemotherapy Leucostim® is administered once a day subcutaneously or intravenously at a dose of 5.0 μg (0.5 million) ME) per 1 kg of body weight of the patient.
In patients receiving cytotoxic chemotherapy, a transient increase in the number of neutrophils is usually observed 1-2 days after the start of treatment with Leucostim®. Daily evaluation of neutrophil count in peripheral blood is desirable to evaluate the effectiveness of treatment. To achieve a stable therapeutic effect, it is necessary to continue therapy with Leukostim® until the number of neutrophils passes the expected minimum and does not reach normal values. After reaching an absolute number of neutrophils in excess of 2.0x109/ l the drug can be canceled. If necessary, the duration of therapy can be up to 12 days, depending on the severity of the disease and the severity of neutropenia.
After myeloablative chemotherapy followed by bone marrow transplantation Leucostim® is administered subcutaneously or intravenously at a rate of 10 μg (1.0 million) ME) per 1 kg of body weight. The first dose of Leucostim® should not be given earlier,than 24 hours after cytotoxic chemotherapy, and when bone marrow transplantation - no later than 24 hours after the infusion of the bone marrow. After the moment of the maximum decrease in the number of neutrophils passes, the daily dose is adjusted depending on the dynamics of their number. If the content of neutrophils in peripheral blood exceeds 1.0x109/ l for three consecutive days, the dose of Leucostim® is halved (to 5.0 μg (0.5 million) ME) per 1 kg of body weight). Then, if the absolute number of neutrophils exceeds 1.0x109/ l for three consecutive days, Leucostim® is canceled. In the case of a decrease in the absolute number of neutrophils during treatment, less than 1.0x09/ l, the dose of Leucostim® is again increased to 10 μg (1.0 million) ME) per 1 kg of body weight.
For mobilization of hematopoietic stem cells Leucostim® is administered subcutaneously at a daily dose of 5.0 μg (0.5 million; ME) per 1 kg of body weight (in patients after myelosuppressive chemotherapy) or 10 μg (1.0 million) ME) per 1 kg of patient weight (in the absence of chemotherapy) for 5-7 consecutive days (the number of administrations depends on the rate of increase in the number of leukocytes in the peripheral blood and the effectiveness of separation).The day before the anticipated period of the first separation (the 4th day of Leukostim® administration) and the following days (until the last separation day), the number of leukocytes and neutrophils in the peripheral blood of the patient is estimated. Cytapheresis is performed in the case of an increase in the number of leukocytes to 5x10 / L of peripheral blood, starting from the 5th day of administration of Leucostim®. After each separation, the number of nucleated cells is counted and Cd34+ cells in a cryoconservation sample. When the number of cryopreserved Cd34+ cells, which is sufficient for transplantation (at least 2x106 per kg of patient weight), the injection of Leucostim® is stopped.
The efficacy and safety of using Leucostim® in healthy donors under the age of 16 and older than 60 years have not been investigated.
When severe chronic neutropenia (THC) Leukostim® should be injected daily subcutaneously until the number of neutrophils is consistently greater than 1.5 × 109/ l (with congenital neutropenia - at a dose of 12 μg (1.2 million) ME) per 1 kg of patient weight per day subcutaneously in one or more administrations; for idiopathic or intermittent neutropenia, 5.0 μg (0.5 million; ME) per 1 kg of weight per day).After achieving the therapeutic effect, it is necessary to determine the minimum effective dose to maintain this level of neutrophils. This requires a long daily administration of the drug. 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, dose adjustment should be performed to maintain the number of neutrophils in the range of 1.5-10 × 109/ l.
When neutropenia associated with HIV infection: the initial dose of 1-4 μg (0.1-0.4 million; ME) per 1 kg of body weight per day once subcutaneously to normalize the number of neutrophils (> 2x109/ l). Normalization of the number of neutrophils usually occurs in 2 days. If the initial dose is not effective, it escalates to 5.0 μg (0.5 million) ME) per 1 kg of weight per day once subcutaneously. After the therapeutic effect is achieved, maintenance therapy with Leucostim® in a dose of 1-4 μg (0.1-0.4 million) ME) for 1 kg of weight per day 2-3 times a week. In the future, individual dose adjustment and long-term therapy with Leucostim® may be required to maintain the number of neutrophils more 2,0x109/ l.
Special instructions for dosing:
When applying filgrastim in pediatric practice in patients with severe chronic neutropenia and oncological diseases, the safety profile of filgrastim did not differ from that in adults. Recommendations for dosing for children of the same age are the same as for adults receiving myelosuppressive or cytotoxic chemotherapy.
Correction of filgrastim dose is not required in patients with severe renal or hepatic insufficiency, since their pharmacokinetic and pharmacodynamic indices are similar to those of healthy volunteers.