General recommendations
Granogen® is administered daily subcutaneously without dilution or in the form of short (within 30 min) intravenous infusions in a 5% dextrose solution. Treatment is performed until the number of neutrophils passes the expected minimum (nadir) and returns to the normal range. The choice of route of administration depends on the specific clinical situation. Preferably a subcutaneous route of administration.
The first dose of Granogen should be administered no earlier than 24 hours after the last administration of cytotoxic drugs.
Breeding instructions
Granogen® can not be diluted with 0.9% sodium chloride solution.
If necessary, Granogen® can be diluted with 5% dextrose solution. If Granogen® is diluted to a concentration of less than 1.5 million units (15 μg) / ml, serum 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 the drug is less than 30 million units (300 μg) should be administered with the addition of 0.2 ml of 20% human albumin solution).
Do not dilute the drug to a final concentration of less than 0.2 million units (2 μg) in 1 ml.
The drug in the opened bottle is not subject to further storage.
Standard schemes:
For the treatment of neutropenia after a course of cytotoxic therapy Granogen® is administered once a day subcutaneously or intravenously at a dose of 0.5 million units (5 μg) / kg. An increase in the number of neutrophils is usually observed 1-2 days after the start of treatment. To achieve a stable therapeutic effect, it is necessary to continue therapy until the number of neutrophils passes through the expected minimum (nadir) and reaches the normal values. It is not recommended to cancel the drug prematurely, until the number of neutrophils passes through the expected minimum. Treatment is discontinued if the absolute number of neutrophils after nadir has reached 1.0 × 109/ l. After the chemotherapy for solid tumors, the estimated duration of treatment can be up to 14 days. After induction and consolidation therapy of acute myelogenous leukemia, the duration of filgrastim administration may be longer, depending on the type, doses and the used scheme of cytotoxic chemotherapy.
After myeloablative therapy followed by bone marrow transplantation Granogen® is administered in an initial dose of 1 million units (10 μg) / kg per day subcutaneously or intravenously drip. The first dose of Granogen® should be administered no earlier than 24 hours after cytotoxic chemotherapy, and with bone marrow transplantation - no later than 24 hours after the infusion of the bone marrow.
After the maximum reduction in the number of neutrophils, the daily dose is adjusted depending on the dynamics of the growth of the number of neutrophils. If the absolute number of neutrophils exceeds 1.0 × 109/ l for 3 consecutive days, the dose is reduced to 0.5 million units (5 μg) / kg per day; then, if the absolute number of neutrophils exceeds 1.0x109/ l for the next 3 days in a row, the drug is canceled. If during the treatment period the absolute number of neutrophils is less than 1.0 × 109/ l, the dose is increased again in accordance with the above scheme.
To mobilize peripheral blood stem cells (PSKK), conducted without chemotherapy, Granogen® is used at a dose of 1 million units (10 μg) / kg per day for 6 days by continuous 24-hour intravenous infusion or subcutaneous administration once a day. It is recommended to perform three leukapheresis in a row - on the 5th, 6th and 7th days.
To mobilize PSKK, conducted after myelosuppressive therapy Granogen® is prescribed in a dose of 0.5 million units (5 μg) / kg per day, subcutaneously, starting 1 day after completion of chemotherapy until the number of neutrophils passes through the expected minimum and reaches normal values. Leukapheresis should be performed during the period when the absolute number of neutrophils is in the range of 0.5 x 109/ l up to 5,0х109/ l.
To mobilize PSKK in healthy donors for subsequent allogeneic transplantation Granogen® is prescribed at a dose of 1 million units (10 μg) / kg per day subcutaneously for 4-5 days. Leukapheresis is performed on the 5th and, if necessary, on the 6th day, to obtain a cellular graft containing at least 2x106 cells CD34 + / kg body weight of the recipient.
In severe chronic neutropenia (TCN) Granogen® is prescribed in a dose of 0.5 million units (5 μg) / kg per day subcutaneously for several days until a stable increase in the number of neutrophils is more than 1.5 × 109/ l. After reaching the therapeutic effect, the minimum effective dose is determined to maintain this level of neutrophils. This requires a long daily administration. After 1-2 weeks of treatment, the initial dose can be doubled or reduced by 50%, depending on the patient's response to therapy.Subsequently, every 1-2 weeks, individual dose adjustment should be performed to maintain the number of neutrophils in the range 15-10.0 × 109/ l.
With neutropenia associated with HIV infection the initial dose of Granogen® is 0.1-0.5 million units / kg (1-5 μg / kg) per day once subcutaneously to normalize the amount of neutrophils. Normalization of neutrophil counts usually occurs after 2 days. After reaching the therapeutic effect, the usual maintenance dose is 300 μg once a day 2-3 times a week, according to an alternating schedule (every other day). Subsequently, individual dose adjustment and long-term administration of the drug may be required to maintain the average number of neutrophils> 2.0x109/ l.
Special instructions for dosing
Recommendations for filgrastim dosage for patients of childhood, receiving cytotoxic chemotherapy are the same as for adults, due to the fact that the kinetic parameters and safety profile of filgrastim in adults and children are the same.
Correction of filgrastim dose is not required in patients with severe renal or hepatic insufficiency, since their pharmacokinetic and pharmacodynamic parameters are similar to those of healthy volunteers.