Active substanceFilgrastimFilgrastim
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  • Dosage form: & nbspsolution for intravenous and subcutaneous administration
    Composition:

    1 ml of the solution contains:

    active substance: filgrastim 300 μg (30 million IU / ml);

    Excipients: sorbitol 50 mg, polysorbate-80 0.04 mg, stabilizer sodium acetate trihydrate 1.36 mg, 1 M solution of acetic acids to a pH of 3.5-4.5, water for injection up to 1 ml.

    Description:

    Colorless or slightly yellowish color, clear or slightly opalescent liquid.

    Pharmacotherapeutic group:leukopoiesis stimulant
    ATX: & nbsp

    L.03.A.A.02   Filgrastim

    Dosing and Administration:

    Nejpomaks® can be administered by daily subcutaneous (SC) injections or daily short (30-minute) intravenous (IV) infusions. 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

    5 μg / kg body weight once a day daily subcutaneously or intravenously drip for 30 minutes until after the expected maximum decrease in the level of neutrophils, their number will not recover to normal, when the drug can be canceled .

    The first dose of Neupomax® 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 for acute myelogenous leukemia, the duration of Neimomax® may increase to 38 days, depending on the type, dosage and chemotherapy 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 amount of neutrophils exceeding 10,000 / μl, treatment with Neimaxax® is stopped,

    Myeloablative therapy followed by autologous or allogeneic bone marrow transplantation

    The initial dose is 10 μg / kg per day intravenously drip for 30 minutes or 24 hours, or as a 24-hour infusion.

    The first dose of Neuromax® should be administered no earlier than 24 hours after cytotoxic chemotherapy, and for 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 corrected depending on the dynamics of the neutrophil content. With an absolute neutrophil count of more than 1000 / μL for three consecutive days, the dose of Neuromax® is reduced to 5 μg / kg / day. If the absolute amount of neutrophils exceeds 1000 / μL for 3 consecutive days, the administration of Neuromax® is stopped. If, during treatment, the absolute amount of neutrophils decreases to less than 1000 / μL, the dose of Neupomax® is increased again, according to the above scheme.

    Mobilization of peripheral blood stem cells in patients with neoplastic diseases

    At 10 mcg / kg once a day sc, 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 administration of Neupomax® should be continued until the last leukapheresis is carried out.

    Mobilization of PSKC after myelosuppressive chemotherapy

    At 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 PSKC in healthy donors for allogeneic transplantation

    At 10 mg / kg / day n / k for 4-5 days and carrying 1 or 2 leukapheresis usually yields more 4x106 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)

    Neypomaks® administered in an initial dose of 12 mg / kg / day in congenital neutropenia and 5 mg / kg / day, or in idiopathic neutropenia periodic subcutaneously once or by several administrations daily as long as the number of neutrophils not be stably exceed 1500 / ml. 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 1-4 μg (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 10 mcg / kg. After achieving therapeutic effect, it is recommended to apply Neupomax® in a maintenance dose: 300 mcg p / c every other day. Subsequently, the doses are corrected in each individual case separately to maintain an average number of neutrophils greater than 2000 / μL.

    Application in children's practice

    Recommendations for dosing for sick children are the same as for adults.

    Elderly patients, patients with impaired renal or hepatic function

    Neutomax® dose adjustment is not required.

    Breeding instructions

    When administered subcutaneously the drug should not be diluted further.

    When preparing a solution for infusions Neupomax® is diluted with only 5% dextrose solution. Dilution 0.9% solution of sodium chloride is not allowed (pharmaceutical incompatibility).

    Neupomax ® diluted in a concentration of 2 to 15 μg / 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 2 mg / ml. For a diluted solution of Nejpomax® at a concentration of more than 15 μg / ml, the addition of albumin is not required.

    Neupomax ® should not be diluted to a concentration of less than 2 μg / ml.

    Overdose:

    The effect of Neupomax ® overdose is unknown. In 1-2 days after discontinuation of the drug, the number of circulating neutrophils is usually reduced by 50%, with a return to normal after 1-7 days.

    Special instructions:

    Treatment with Neuromax® should only be performed under the supervision of a physician who has experience with colony-stimulating factors, provided that the necessary diagnostic capabilities are available. Procedures for mobilization and apheresis of cells should be carried out in specialized medical institutions.

    The safety and efficacy of filgrastim in patients with myelodysplastic syndrome and chronic myeloid leukemia have not been established, and in connection with these diseases, filgrastim Not recommended. Particular attention should be given to the differential diagnosis between acute myelogenous leukemia and an imperious crisis of chronic myelogenous leukemia.

    Before the appointment of Neuromax®, patients with severe chronic neutropenia (TCN) should be carefully diagnosed in order to exclude other hematologic diseases such as aplastic anemia, myelodysplasia and chronic myeloid leukemia (a morphological and cytogenetic analysis of the bone marrow should be performed before the start of therapy).

    In the application of filgrastim in patients with THC, there were cases of myelodysplastic syndrome and acute myeloblastic leukemia. Despite the fact that the relationship of the development of these diseases with filgrastim is not established, the drug should be used with TCN with caution under the control of morphological and cytogenetic analysis of the bone marrow (1 every 12 months). When cytogenetic abnormalities appear in the bone marrow, the risk and benefit of further therapy with filgrastim should be carefully assessed. When developing MDS or Neuromax leukemia, it should be canceled.

    Treatment with Neimoxax® should be performed under regular control of a general blood test, with a calculation of the leukocyte count and the number of platelets (before starting therapy and then twice a week with standard chemotherapy and at least 3 times per week in mobilizing PSKK with or without a subsequent bone marrow transplantation). When Neimomax ® is used to mobilize PSKK, the drug is canceled when the number of leukocytes exceeds 100,000 / μl. With a stable platelet count of less than 100,000 / μL, it is recommended that you temporarily stop filgrastim therapy or reduce its dose.

    Filgrastim does not prevent thrombocytopenia caused by myelosuppressive chemotherapy and anemia.

    During treatment with Neipomax®, urine tests should be performed regularly (to exclude hematuria and proteinuria) and control the size of the spleen.

    Filgrastim should be used with caution in patients with sickle cell disease due to the possible development of a marked increase in the number of sickle cells.

    Safety and efficacy of the drug in newborns and patients with autoimmune neutropenia have not been established.

    Patients with concomitant osteal pathology and osteoporosis receiving continuous treatment with Neuromax® for more than 6 months are shown to control the density of bone tissue.

    The effect of filgrastim on the "graft versus host" reaction has not been established.

    Form release / dosage:Solution for intravenous and subcutaneous administration, 300 μg (30 million IU / ml.
    Packaging:

    According to 1.0 ml (300 μg, 30 million ME) or 1.6 ml (480 μg, 48 million ME) in glass bottles, ukuporennyh stoppers from rubber blends with the rolling of aluminum caps.

    5 bottles, packed in a polyvinylchloride film outline with the instruction for medical use, are placed in a pack of cardboard.

    Storage conditions:

    Store in a dark place at a temperature of 2 to 8 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:2 years.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-004332/07
    Date of registration:28.11.2007
    The owner of the registration certificate:PHARMSTANDART-UFIM VITAMIN FACTORY, OJSC PHARMSTANDART-UFIM VITAMIN FACTORY, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspPHARMSTANDART-Ufa-VITA, JSCPHARMSTANDART-Ufa-VITA, JSC
    Information update date: & nbsp24.09.2015
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