Neipomax, 30 million units/ml, solution for intravenous and subcutaneous administration, 1 ml, 5 pcs.
Neupomax® can be administered by daily subcutaneous (SC) injection or daily short (30-minute) intravenous (IV) infusion. The drug can also be administered as a 24-hour intravenous or subcutaneous infusion.
The choice of route of administration should depend on the specific clinical situation, but in most cases the subcutaneous route of administration is preferred.
To avoid pain during injection, it is best to change the injection site daily.
Standard cytotoxic chemotherapy regimens
5 mcg/kg body weight 1 time per day daily subcutaneously or intravenously for 30 minutes until, after the expected maximum decrease in the level of neutrophils, their number is restored to normal, upon reaching which the drug can be discontinued .
The first dose of Neipomax® should be administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy. Duration of therapy is up to 14 days. After induction and consolidation therapy for acute myeloid leukemia, the duration of use of Neipomax® may increase to 38 days, depending on the type, dose and chemotherapy regimen used.
Typically, a transient increase in the number of neutrophils is observed 1-2 days after the start of treatment with filgrastim. To achieve a stable therapeutic effect, interrupting treatment until normal neutrophil values are achieved after the expected maximum decrease in their level is not recommended. When the absolute number of neutrophils exceeds 10,000/μl, treatment with Neypomax® is stopped.
Myeloablative therapy
by
autologous or allogeneic bone marrow transplantation.
Initial dose: 10 mcg/kg per day intravenously over 30 minutes or 24 hours, or as a 24-hour subcutaneous infusion.
The first dose of Neipomax® should be administered no earlier than 24 hours after cytotoxic chemotherapy, and in case of bone marrow transplantation - no later than 24 hours.
The duration of therapy is no more than 28 days. The daily dose of the drug is adjusted depending on the dynamics of neutrophil content. If the absolute neutrophil count is more than 1000 / μl for three consecutive days, the dose of Neipomax® is reduced to 5 μg / kg / day. If, when using this dose for another 3 days in a row, the absolute number of neutrophils exceeds 1000/μl, the administration of Neipomax® is stopped. If during treatment the absolute number of neutrophils decreases to a level of less than 1000/μl, the dose of Neipomax® is increased again in accordance with the above scheme.
Mobilization of peripheral blood stem cells in patients with tumor diseases
10 mcg/kg 1 time per day subcutaneously or by continuous 24-hour subcutaneous infusion for 6 consecutive days. In this case, 2 leukapheresis are usually performed in a row, on the 5th and 6th days. In case of additional leukapheresis, the administration of Neipomax should be continued until the last leukapheresis.
Mobilization of PSCC after myelosuppressive chemotherapy
5 mcg/kg per day by daily subcutaneous injection, starting from the first day after completion of chemotherapy until the number of neutrophils reaches normal values.
Leukapheresis should only be performed when the absolute neutrophil count exceeds normal values (>2000/µl).
Mobilization of PSCCs from healthy donors for allogeneic transplantation
10 mcg/kg/day subcutaneously for 4–5 days and 1 or 2 leukapheresis usually allows to obtain more than 4 × 106 CD34+ cells/kg body weight of the recipient. There are no data on the safety and effectiveness of filgrastim in healthy donors under 16 and over 60 years of age.
Severe chronic neutropenia (SCN)
Neipomax® is prescribed at an initial dose of 12 mcg/kg/day for congenital neutropenia and 5 mcg/kg/day for idiopathic or periodic neutropenia, subcutaneously once or by multiple injections daily until the neutrophil count consistently exceeds 1500/mcL. After achieving a therapeutic effect, 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. Thereafter, individual dose adjustments can be made every 1–2 weeks to maintain the mean neutrophil count in the range of 1500–10000/μL. In patients with severe infections, a more rapid dose escalation regimen may be used. The safety of filgrastim in long-term treatment of patients with SCN with doses greater than 24 mcg per day has not been established.
Neutropenia in HIV infection
The initial dose is 1–4 mcg (0.1–0.4 million IU)/kg subcutaneously once a day until the number of neutrophils normalizes. The maximum daily dose should not exceed 10 mcg/kg. After achieving a therapeutic effect, it is recommended to use Neipomax® in a maintenance dose: 300 mcg subcutaneously every other day. Subsequently, doses are adjusted on a case-by-case basis to maintain an average neutrophil count greater than 2000/µl.
Application in pediatric practice
Dosing recommendations for pediatric patients are the same as for adults.
Elderly patients, patients with impaired renal or hepatic function
No dose adjustment of Neypomax® is required.
Breeding instructions
When administered subcutaneously, the drug should not be further diluted.
When preparing a solution for infusion, Neipomax® is diluted with only a 5% dextrose solution. Dilution with 0.9% sodium chloride solution is not allowed (pharmaceutical incompatibility).
Neipomax® in diluted form at a concentration of 2 to 15 μg/ml can be adsorbed by glass and plastics. In this case, to prevent absorption, it is necessary to add human serum albumin to the solution in the required amount to achieve its concentration in the final solution of 2 mg/ml. For a diluted solution of Neipomax® at a concentration of more than 15 mcg/ml, the addition of albumin is not required.
Neipomax® cannot be diluted to a concentration of less than 2 mcg/ml.
Neipomax solution d/in 30 million IU/ml 1.6 ml N5 (Pharmstandard)
Neupomax can be administered by daily subcutaneous (SC) injections or daily short (30-minute) intravenous (IV) infusions. The drug can also be administered as a 24-hour intravenous or subcutaneous infusion. The choice of route of administration should depend on the specific clinical situation, but in most cases the subcutaneous route of administration is preferred. To avoid pain, it is best to change the injection site daily during administration. Standard cytotoxic chemotherapy regimens 5 mcg/kg body weight 1 time per day daily subcutaneously or intravenously for 30 minutes. until, after the expected maximum decrease in the level of neutrophils, their number is restored to normal levels, upon reaching which the drug can be discontinued. The first dose of Neipomax should be administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy. Duration of therapy is up to 14 days. After induction and consolidation therapy for acute myeloid leukemia, the duration of use of Neipomax may increase to 38 days, depending on the type, dose and chemotherapy regimen used. Typically, a transient increase in the number of neutrophils is observed 1-2 days after the start of treatment with filgrastim. To achieve a stable therapeutic effect, interrupting treatment until normal neutrophil values are achieved after the expected maximum decrease in their level is not recommended. When the absolute number of neutrophils exceeds 10,000/μl, treatment with Neypomax is stopped. Myeloablative therapy followed by autologous or allogeneic bone marrow transplantation Initial dose - 10 mcg/kg per day intravenously drip over 30 minutes or 24 hours, or as a 24-hour subcutaneous injection infusion. The first dose of Neipomax should be administered no earlier than 24 hours after cytotoxic chemotherapy, and in case of bone marrow transplantation - no later than 24 hours. Duration of therapy is no more than 28 days. The daily dose of the drug is adjusted depending on the dynamics of neutrophil content. If the absolute number of neutrophils is more than 1000 / μl for three consecutive days, the dose of Neipomax is reduced to 5 μg / kg / day. If, when using this dose for another 3 days in a row, the absolute number of neutrophils exceeds 1000/μl, the administration of Neipomax is stopped. If during treatment the absolute number of neutrophils decreases to a level of less than 1000/μl, the dose of Neipomax is increased again, in accordance with the above scheme. Mobilization of peripheral blood stem cells in patients with tumor diseases. 10 mcg/kg 1 time per day subcutaneously or by continuous 24-hour subcutaneous infusion for 6 consecutive days. In this case, 2 leukapheresis are usually performed in a row, on the 5th and 6th days. In case of additional leukapheresis, the administration of Neipomax should be continued until the last leukapheresis. Mobilization of PSCC after myelosuppressive chemotherapy 5 mcg/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 PSCC in healthy donors for allogeneic transplantation 10 μg/kg/day subcutaneously for 4-5 days and 1 or 2 x leukapheresis usually allows to obtain more than 4 x 106 CD34+ cells/kg of recipient body weight. There are no data on the safety and effectiveness of filgrastim in healthy donors under 16 and over 60 years of age. Severe chronic neutropenia (SCN) Neipomax is prescribed at an initial dose of 12 mcg/kg/day for congenital neutropenia and 5 mcg/kg/day for idiopathic or periodic neutropenia subcutaneously once or by several injections daily until the neutrophil count consistently exceeds 1500/μl. After achieving a therapeutic effect, 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, individual dose adjustments can be made every 1-2 weeks to maintain the average neutrophil count in the range of 1500-10000/μl. In patients with severe infections, a more rapid dose escalation regimen may be used. The safety of filgrastim in long-term treatment of patients with SCN with doses of more than 24 mcg per day has not been established. Neutropenia in HIV infection Initial dose 1-4 mcg (0.1-0.4 million units)/kg subcutaneously once a day until the amount normalizes neutrophils. The maximum daily dose should not exceed 10 mcg/kg. After achieving a therapeutic effect, it is recommended to use Grasalva in a maintenance dose: 300 mcg subcutaneously every other day. Subsequently, doses are adjusted in each individual case separately to maintain the average number of neutrophils more than 2000/μl. Use in pediatric practice Dosing recommendations for pediatric patients are the same as for adults. Elderly patients, patients with impaired renal or hepatic function. No dose adjustment of Neipomax is required. Directions for dilution When administered subcutaneously, the drug should not be further diluted. When preparing a solution for infusion, Neipomax is diluted only with a 5% dextrose solution. Dilution with a 0.9% sodium chloride solution is not allowed (pharmaceutical incompatibility). Neipomax in diluted form at a concentration of 2 to 15 mcg/ml can be adsorbed by glass and plastics. In this case, to prevent absorption, it is necessary to add human serum albumin to the solution in the required amount to achieve its concentration in the final solution of 2 mg/ml. For a diluted solution of Neipomax at a concentration of more than 15 μg/ml, the addition of albumin is not required. Neipomax cannot be diluted to a concentration of less than 2 μg/ml.
Neupomax®
Neupomax® can be administered by daily subcutaneous (SC) injection or daily short (30-minute) intravenous (IV) infusion. The drug can also be administered as a 24-hour intravenous or subcutaneous infusion.
The choice of route of administration should depend on the specific clinical situation, but in most cases the subcutaneous route of administration is preferred.
To avoid pain during injection, it is best to change the injection site daily.
Standard cytotoxic chemotherapy regimens
5 mcg/kg body weight 1 time per day daily subcutaneously or intravenously for 30 minutes until, after the expected maximum decrease in the level of neutrophils, their number is restored to normal, upon reaching which the drug can be discontinued .
The first dose of Neipomax® should be administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy. Duration of therapy is up to 14 days. After induction and consolidation therapy for acute myeloid leukemia, the duration of use of Neipomax® may increase to 38 days, depending on the type, dose and chemotherapy regimen used.
Typically, a transient increase in the number of neutrophils is observed 1-2 days after the start of treatment with filgrastim. To achieve a stable therapeutic effect, interrupting treatment until normal neutrophil values are achieved after the expected maximum decrease in their level is not recommended. If the absolute number of neutrophils exceeds 10,000/μl, treatment with Neypomax® is stopped.
Myeloablative therapy followed by autologous or allogeneic bone marrow transplantation
The initial dose is 10 mcg/kg per day intravenously drip over 30 minutes or 24 hours, or as a 24-hour subcutaneous infusion.
The first dose of Neipomax® should be administered no earlier than 24 hours after cytotoxic chemotherapy, and in case of bone marrow transplantation - no later than 24 hours.
The duration of therapy is no more than 28 days. The daily dose of the drug is adjusted depending on the dynamics of neutrophil content. If the absolute neutrophil count is more than 1000/μl for three consecutive days, the dose of Neipomax® is reduced to 5 μg/kg/day. If, when using this dose for another 3 days in a row, the absolute number of neutrophils exceeds 1000/μl, the administration of Neipomax® is stopped. If during treatment the absolute number of neutrophils decreases to a level of less than 1000/μl, the dose of Neipomax® is increased again in accordance with the above scheme.
Mobilization of peripheral blood stem cells in patients with tumor diseases
10 mcg/kg 1 time per day subcutaneously or by continuous 24-hour subcutaneous infusion for 6 consecutive days. In this case, 2 leukapheresis are usually performed in a row, on the 5th and 6th days. In case of additional leukapheresis, the administration of Neipomax should be continued until the last leukapheresis.
Mobilization of PSCC after myelosuppressive chemotherapy
5 mcg/kg per day by daily subcutaneous injection, starting from the first day after completion of chemotherapy until the number of neutrophils reaches normal values.
Leukapheresis should only be performed when the absolute neutrophil count exceeds normal values (> 2000/µl).
Mobilization of PSCCs from healthy donors for allogeneic transplantation
10 mcg/kg/day subcutaneously for 4-5 days and 1 or 2 leukapheresis usually allows to obtain more than 4x106CD34+ cells/kg body weight of the recipient.
There are no data on the safety and effectiveness of filgrastim in healthy donors under 16 and over 60 years of age.
Severe chronic neutropenia (SCN)
Neipomax® is prescribed at an initial dose of 12 mcg/kg/day for congenital neutropenia and 5 mcg/kg/day for idiopathic or periodic neutropenia, subcutaneously once or by multiple injections daily until the neutrophil count consistently exceeds 1500/mcL. After achieving a therapeutic effect, 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, individual dose adjustments can be made every 1-2 weeks to maintain the average neutrophil count in the range of 1500-10000/μl. In patients with severe infections, a more rapid dose escalation regimen may be used. The safety of filgrastim in long-term treatment of patients with SCN with doses greater than 24 mcg per day has not been established.
Neutropenia in HIV infection
The initial dose is 1-4 mcg (0.1-0.4 million IU)/kg subcutaneously 1 time per day until the number of neutrophils normalizes. The maximum daily dose should not exceed 10 mcg/kg. After achieving a therapeutic effect, it is recommended to use Neipomax® in a maintenance dose: 300 mcg subcutaneously every other day. Subsequently, doses are adjusted on a case-by-case basis to maintain an average neutrophil count greater than 2000/µl.
Application in pediatric practice
Dosing recommendations for pediatric patients are the same as for adults.
Elderly patients, patients with impaired renal or hepatic function
No dose adjustment of Neypomax® is required.
Breeding instructions
When administered subcutaneously
The drug should not be further diluted.
When preparing a solution for infusion
Neipomax® is diluted with only 5% dextrose solution. Dilution with 0.9% sodium chloride solution is not allowed (pharmaceutical incompatibility).
Neipomax® in diluted form at a concentration of 2 to 15 μg/ml can be adsorbed by glass and plastics. In this case, to prevent absorption, it is necessary to add human serum albumin to the solution in the required amount to achieve its concentration in the final solution of 2 mg/ml. For a diluted solution of Neipomax® at a concentration of more than 15 mcg/ml, the addition of albumin is not required.
Neipomax® cannot be diluted to a concentration of less than 2 mcg/ml.
