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Instructions

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Instruction for use: Neupogen

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Dosage form: Solution for intravenous and subcutaneous administration

Active substance: Filgrastimum

ATX

L03AA02 Filgrastim

Pharmacological group:

Stimulators of hemopoiesis

The nosological classification (ICD-10)

D70 Agranulocytosis: Agranulocytosis is hereditary; Aleicia; Aleykocytosis; Agranulocytic angina; Angina agranulocytic; Primary cytopenia

D71 Functional disorders of polymorphonuclear neutrophils

D72.8.0 * Leukopenia: Autoimmune neutropenia; Congenital neutropenia; Granulocytopenia; Idiopathic and drug-induced leukopenia; Idiopathic neutropenia; Leukopenia aplastic; Leukopenia radiation; Leukopenia with radiation therapy; Radiation leukopenia; Hereditary neutropenia; Neutropenia in patients with AIDS; Periodic neutropenia; Radiation leukopenia; Persistent neutropenia; Febrile neutropenia; Two-stage cytopenia; Radiation cytopenia; Neutropenia is cyclic

Z51.1 Chemotherapy for neoplasm: Cystitis hemorrhagic, caused by cytostatics; Urotoxicity of cytostatics

Composition and release form

Solution for intravenous and subcutaneous administration 1 fl.

Filgrastim 30 million units (300 mkg); 48 million units (480 mkg)

Auxiliary substances: sorbitol, polysorbate 80, glacial acetic acid, sodium hydroxide, water for injections

In the vial 1 ml (30 million units) or 1.6 ml (48 million units); In a pack of cardboard 1 or 5 bottles.

A solution for subcutaneous administration of 1 bar-tube.

Filgrastim 30 million units (300 mkg); 48 million units (480 mkg)

Auxiliary substances: sorbitol, polysorbate 80, glacial acetic acid, sodium hydroxide, water for injections

In a syringe tube of 0.5 ml complete with a needle for injection; In a pack of cardboard 1 or 5 sets.

Description of dosage form

Transparent colorless or slightly yellowish liquid, odorless or with a faint odor.

Pharmachologic effect

Mode of action - Hematopoietic.

Pharmacodynamics

Hematopoietic growth factor.

Filgrastim is a highly purified, non-glycosylated protein, consisting of 175 amino acids. It is produced by the strain K12 Escherichia coli, into the genome of which gene of granulocyte human colony-stimulating factor was introduced into the genome by genetic engineering methods.

Human granulocyte colony-stimulating factor (G-CSF) is a glycoprotein that regulates the formation of functionally active neutrophils and their release into the blood from the bone marrow. Neupogen® containing recombinant G-CSF significantly increases the number of neutrophils in the peripheral blood as early as the first 24 hours after administration, with a slight increase in the number of monocytes. In patients with severe chronic neutropenia, Neupogen® may cause a slight increase in the number of circulating eosinophils and basophils.

Neupogen ® dose-dependently increases the number of neutrophils with normal or increased functional activity. After the end of treatment, the number of neutrophils in peripheral blood is reduced by 50% within 1-2 days and returns to normal level during the next 1-7 days. Duration of action with / in the introduction may be shortened. The clinical significance of this phenomenon with repeated administration of the drug is unclear.

Neupogen ® significantly reduces the frequency, severity and duration of neutropenia and febrile neutropenia, reducing the need and duration of inpatient treatment in patients receiving chemotherapy with cytostatics or myeloablative therapy followed by bone marrow transplantation.

Patients receiving Neupogen® and cytotoxic chemotherapy require smaller doses of antibiotics compared to patients receiving only cytotoxic chemotherapy.

Treatment with Neupogen ® significantly reduces the duration of febrile neutropenia, the need for antibiotic therapy and hospitalization after induction chemotherapy for acute myelogenous leukemia, without affecting the incidence of fever and infectious complications.

The use of Neupogen ® both independently and after chemotherapy, mobilizes the release of hematopoietic stem cells into the peripheral bloodstream. Autologous or allogeneic transplantation of peripheral blood stem cells (PSKK) is performed after therapy with large doses of cytostatics, or instead of bone marrow transplantation, or in addition to it. Transplantation of PSKK can also be administered after (high-dose) myelosuppressive cytotoxic therapy. The use of PSKC, mobilized with Neupogen®, accelerates the recovery of hematopoiesis, reduces the severity and duration of thrombocytopenia, the risk of hemorrhagic complications and the need for transfusion of platelet mass after myelosuppressive or myeloablative therapy.

The efficacy and safety of Neupogen ® in adults and children receiving cytotoxic chemotherapy are the same.

In children and adults with severe chronic neutropenia (severe congenital, periodic, idiopathic neutropenia), Neupogen® stably increases the number of neutrophils in peripheral blood, reduces the incidence of infectious complications.

The appointment of Neupogen® to patients with HIV infection can maintain a normal level of neutrophils and follow recommended doses of antiretroviral and / or other myelosuppressive therapy. There were no signs of an increase in HIV replication with Neupogen®.

Like other hematopoietic growth factors, G-CSF stimulates human endothelial cells in vitro.

Pharmacokinetics

With IV and SC administration of filgrastim a positive linear relationship between the administered dose and serum concentration is observed. After subcutaneous administration of therapeutic doses, its concentration exceeds 10 ng / ml for 8-16 hours. The volume of distribution is 150 ml / kg.

Regardless of the mode of administration, the elimination of filgrastim proceeds according to the rules of kinetics of the first order. T1 / 2 - 3,5 h, the clearance is 0,6 ml / min / kg.

Long-term administration of filgrastim up to 28 days after autologous bone marrow transplantation does not lead to cumulation and an increase in T1 / 2.

In patients with end-stage renal disease, an increase in Cmax and an area under the curve (AUC) is observed, and a decrease in the volume of distribution and clearance compared to healthy volunteers and patients with moderate-level renal failure.

Indications of the Neupogen

Neutropenia, febrile neutropenia in patients receiving intensive myelosuppressive cytotoxic chemotherapy for malignant diseases (with the exception of chronic myelogenous leukemia and myelodysplastic syndrome), as well as neutropenia and its clinical consequences in patients receiving myeloablative therapy followed by allogeneic or autologous bone marrow transplantation;

Mobilization of peripheral blood stem cells, including after myelosuppressive therapy;

Severe congenital, periodic or idiopathic neutropenia (absolute number of neutrophils less than or equal to 0.5 · 109 / L) in children and adults with severe or recurrent infections in the history;

Persistent neutropenia (absolute number of neutrophils less than or equal to 1.0 · 109 / L) in patients with developed stage of HIV infection to reduce the risk of bacterial infections if other methods of treatment are not possible.

Contraindications

Hypersensitivity to the drug or its components in anamnesis;

Severe congenital neutropenia (Costman's syndrome) with cytogenetic disorders;

Neupogen® should not be used to increase doses of cytotoxic chemotherapeutic drugs above those recommended;

Simultaneous administration with cytotoxic chemo- and radiotherapy;

Terminal stage of chronic renal failure;

lactation;

The period of newborns (immediately after birth until 28 days of life).

Carefully:

pregnancy;

Malignant and premalignant diseases of a myeloid nature (including acute myelogenous leukemia de novo and secondary);

In combination with high-dose chemotherapy.

Application in pregnancy and breastfeeding

The drug category C.

The safety of Neupogen ® for pregnant women is not established. Possible passage of Neupogen® through the placental barrier in women. When prescribing Neupogen®, pregnant women should correlate the expected therapeutic effect with the possible risk to the fetus.

In studies on rats and rabbits, Neupogen® did not have a teratogenic effect. Rabbits had an increased incidence of miscarriages, but there was no abnormality of fetal development.

It is not known whether Neupogen® penetrates into breast milk. It is not recommended to use Neupogen® in lactating mothers.

Side effects

Organism as a whole: headache, fatigue, reactions at the injection site (less than 2% of patients with severe chronic neutropenia (TCN)).

Musculoskeletal system: often - mild or moderate (10%); Sometimes - severe (3%) pain in the bones and muscles, which in most cases are stopped by usual analgesics; Arthralgia, osteoporosis, acute gouty arthritis, exacerbation of rheumatoid arthritis.

Gastrointestinal tract: diarrhea, hepatomegaly.

Cardiovascular system: very rarely - transient arterial hypotension that does not require medical correction, cutaneous vasculitis (with long-term therapy in 2% of patients with TCN), arrhythmias (there is no connection with taking the drug), vascular disorders (veno-occlusive disease, connection with admission Neupogen has not been established).

Respiratory organs: lung infiltrates, adult respiratory distress syndrome, respiratory failure, interstitial pneumonia, possibly with an unfavorable prognosis (after chemotherapy, especially after the appointment of bleomycin-containing regimens, the association with Neupogen® is not established).

Skin and its appendages: alopecia, skin rash; Rarely - Sweet syndrome (febrile acute dermatosis, communication with Neupogen ® is not established).

Blood and lymphatic system: splenomegaly, pain in the upper left quadrant of the abdomen; Rarely - thrombosis of blood vessels; Very rarely - rupture of the spleen, thrombocytopenia, anemia and epistaxis (with long-term administration), leukocytosis, myelodysplastic syndrome and leukemia (in 3% of patients with severe congenital neutropenia (Costman's syndrome), no association with the drug).

Genitourinary system: rarely - mild or moderate dysuria.

Hypersensitivity reactions: rarely - rash. More than half of hypersensitivity reactions are associated with the administration of the first dose, more often after intravenous administration of the drug. Sometimes the resumption of treatment is accompanied by a relapse of symptoms.

Laboratory indicators: reversible, dose-dependent and weak or moderate increase in lactate dehydrogenase, alkaline phosphatase, and γ-glutamyltransferase, hyperuricemia, transient hypoglycemia after eating; Very rarely - proteinuria, hematuria.

Neupogen® does not increase the incidence of adverse reactions to cytotoxic chemotherapy. The adverse events observed with the same frequency in patients receiving Neupogen / chemotherapy and placebo / chemotherapy included nausea and vomiting, alopecia, diarrhea, lethargy, anorexia, mucosal inflammation, headache, cough, skin rash, chest pain, total Weakness, sore throat, constipation and nonspecific pain (without indicating the diagnosis).

Interaction

The safety and efficacy of Neupogen ® administration on the same day as myelosuppressive cytotoxic chemotherapeutic agents have not been established. Due to the sensitivity of the rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, it is not recommended to appoint Neupogen® within 24 hours before or after the administration of these drugs. With the simultaneous administration of Neupogen® and 5-fluorouracil, the severity of neutropenia may worsen. Possible interaction with other hematopoietic growth factors and cytokines is not known.

Given that lithium stimulates the release of neutrophils, it is possible to enhance the action of Neupogen® with a combined prescription, but such studies have not been conducted.

Due to pharmaceutical incompatibility, it should not be mixed with 0.9% sodium chloride solution.

Dosing and Administration

Daily SC or as short IV infusions (30-minute) on a 5% dextrose solution (see "Instructions for breeding") until the number of neutrophils passes the expected minimum (nadir) and returns to the range Normal values. The choice of route of administration depends on the specific clinical situation. Preferably after the route of administration.

Bottles and syringes with Neupogen ® are for single use only.

Standard schemes of cytotoxic chemotherapy

For 0.5 million units (5 mkg) / kg 1 time per day daily sc, or in the form of short intravenous infusions (30-minute) in a 5% dextrose solution. The first dose of Neupogen® is 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 Neupogen ® can be increased up to 38 days, depending on the type, dosage and the used cytotoxic chemotherapy regimen. A transient increase in the number of neutrophils is usually observed 1-2 days after the beginning of Neupogen ® treatment. To achieve a stable therapeutic effect, it is necessary to continue Neupogen ® therapy until the number of neutrophils exceeds the expected minimum and reaches normal values. It is not recommended to abolish Neupogen® prematurely, until the number of neutrophils passes through the expected minimum. Treatment should be discontinued if the absolute number of neutrophils (ACN) after nadir reached 1.0 · 109 / L.

After myeloablative therapy followed by autologous or allogeneic bone marrow transplantation

SC or IV in the form of infusion in 20 ml of a 5% solution of dextrose (see "Instructions for breeding"). The initial dose is 1.0 million units (10 mkg) / kg / day IV drip for 30 minutes or 24 hours or by continuous infusion for 24 hours. The first dose of Neupogen should be administered no earlier than 24 hours after cytotoxic chemotherapy, and with bone marrow transplantation - not later than 24 hours after the infusion of the bone marrow. The duration of therapy is not more than 28 days.

After the maximum reduction in the number of neutrophils (nadir), the daily dose is corrected depending on the dynamics of the neutrophil content. If the neutrophil count exceeds 1.0 · 109 / L for three consecutive days, the dose of Neupogen® is reduced to 0.5 million units / kg / day; Then, if the absolute number of neutrophils exceeds 1.0 · 109 / L for three consecutive days, Neupogen® is canceled. If during the treatment period the absolute amount of neutrophils decreases less than 1,0 · 109 / l, the dose of Neupogen® should be increased again, in accordance with the above scheme.

Mobilization of peripheral blood stem cells after myelosuppressive therapy followed by autologous transfusion of PSKK with or without bone marrow transplantation or in patients with myeloablative therapy followed by transfusion of PSKK

For 1.0 million units (10 mkg) / kg / day by injection once a day or a continuous 24-hour infusion for 6 consecutive days, usually two leukapheresis procedures are sufficient in a row at the 5th , 6th days. In some cases, additional leukapheresis is possible. The administration of Neupogen® should be continued until the last leukapheresis.

Mobilization of PSKC after myelosuppressive chemotherapy

For 0.5 million units (5 mkg) / kg / day by daily injections, starting from the first day after completion of chemotherapy and until the amount of neutrophils passes through the expected minimum and reaches normal values. Leukapheresis should be performed during the period when the absolute amount of neutrophils (DCA) rises from less than 0.5 · 109 / L to more than 5.0 · 109 / L. Patients who did not receive intensive chemotherapy, it is enough to have one leukapheresis. In some cases, additional leukapheresis is recommended.

Mobilization of PSKC in healthy donors for allogeneic transplantation

For 1 million units (10 μg) kg / day for 4 to 5 days. Leukapheresis is carried out from the 5th day and, if necessary, until the 6th day in order to obtain CD34 + ≥4 · 106 cells / kg of body weight of the recipient. Efficacy and safety in healthy donors under the age of 16 and older than 60 years has not been investigated.

Severe chronic neutropenia (THC)

Every day, once or divided into several introductions. With congenital neutropenia: the initial dose is 1.2 million units (12 mkg) / kg / day; For idiopathic or intermittent neutropenia, 0.5 million units (5 mkg) / kg / day until the neutrophil count is 1.5 × 109 / l. After achieving a therapeutic effect, the minimum effective dose should be determined to maintain this level. To maintain the desired number of neutrophils requires a long daily administration of the drug. After 1-2 weeks of treatment, depending on the patient's response to therapy, the initial dose can be doubled or halved. Subsequently, every 1-2 weeks, individual dose adjustment can be performed to maintain the number of neutrophils in the range 1.5-10 · 109 / L. In patients with severe infections, a scheme with a faster increase in dose can be used. In 97% of patients who responded positively to treatment, the full therapeutic effect is observed when doses are prescribed up to 24 mcg / kg / day. The daily dose of Neupogen® should not exceed 24 mcg / kg.

Neutropenia in HIV infection

The initial dose of 0.1-0.4 million units (1-4 mcg) / kg / day once p / to the normalization of the number of neutrophils. The maximum daily dose is no more than 10 μg / kg. The normalization of the number of neutrophils usually comes in 2 days. After reaching the therapeutic effect, the maintenance dose is 300 μg / day 2-3 times a week according to the alternating schedule (every other day). Subsequently, individual dose adjustment and long-term administration of the drug may be required to maintain an average number of neutrophils> 2.0 · 109 / L.

Special instructions for dosing

Elderly: there are no special recommendations for elderly patients.

Children: when applied in pediatric practice in patients with TCN and oncological diseases, the safety profile of Neupogen® did not differ from that in adults. Recommendations for dosing for children of the same age are the same as for adults receiving myelosuppressive cytotoxic chemotherapy.

Dose adjustment is not required in patients with severe renal or hepatic insufficiency, Their pharmacokinetic and pharmacodynamic parameters were similar to those of healthy volunteers.

Information on breeding

Neupogen ® is diluted with only 5% dextrose solution, it is not allowed to dilute with 0.9% sodium chloride solution. Divorced Neupogen® can be adsorbed by glass and plastics. If Neupogen ® is diluted to a concentration of less than 1.5 million units (15 μg) in 1 ml, serum albumin should be added to the solution in an amount such that the final concentration of albumin is 2 mg / ml. For example, for a final solution volume of 20 ml, total doses of Neupogen ® less than 30 million units (300 mkg) should be administered with the addition of 0.2 ml of a 20% albumin solution. Neupogen® when diluted with 5% dextrose solution or 5% dextrose solution and albumin is compatible with glass and a number of plastics, including. PVC, polyolefin (copolymer of polypropylene and polyethylene) and polypropylene.

Do not dilute the drug to a final concentration of less than 0.2 million units (2 μg) in 1 ml.

The finished Neupogen® solution is stored at a temperature of 2 ° to 8 ° C for a maximum of 24 hours.

Overdose

Cases of overdose are not marked. 1-2 days after discontinuation of the drug, the number of circulating neutrophils usually decreases by 50% and returns to the normal level after 1-7 days.

Special instructions

Treatment with Neupogen should be performed only under the supervision of an oncologist or hematologist with experience in the use of G-CSF, provided that the necessary diagnostic capabilities are available. Procedures for mobilization and apheresis of cells should be performed in an oncological or hematological center with experience in this field and the possibility of adequate monitoring of hematopoietic progenitor cells.

A) Growth of malignant cells

The safety and efficacy of Neupogen in patients with myelodysplastic syndrome and chronic myelogenous leukemia have not been established, therefore, it is not indicated in these diseases. Particular attention should be paid to the differential diagnosis between acute myelogenous leukemia and blast crisis of chronic myelogenous leukemia.

Human G-CSF can stimulate the growth of myeloid cells in vitro. Similar effects can be observed in vitro and for some non-myeloid cells.

B) Patients receiving cytotoxic chemotherapy

Leukocytosis: less than 5% of patients receiving Neupogen® at doses greater than 0.3 million units (3 μg / kg / day), the number of leukocytes increased to 100 · 109 / l and more. Any side effects directly related to such leukocytosis are not described. However, given the potential risk associated with high leukocytosis, the number of white blood cells should be regularly determined during treatment with Neupogen ®. If after passing the expected minimum it exceeds 50 · 109 / l, Neupogen® should be immediately canceled. If Neupogen® is used to mobilize PSKK, it is canceled if the number of leukocytes exceeds 70 · 109 / L.

The risk associated with high-dosage chemotherapy: special caution should be exercised in the treatment of patients receiving high-dose chemotherapy, since no improvement in the outcome of malignant neoplasm has been observed, while increased doses of chemotherapy have more pronounced toxicity, including skin reactions and side effects from the cardiovascular side , Nervous and respiratory systems (see instructions for the use of specific chemotherapy drugs).

Monotherapy Neupogenom® does not prevent thrombocytopenia and anemia caused by myelosuppressive chemotherapy. Because of the possibility of using higher doses of chemotherapy (eg, full doses according to the regimens), the patient may be at greater risk of thrombocytopenia and anemia. It is recommended that a blood test be performed twice a week and the number of platelets and hematocrit is determined. Particular caution should be exercised when using single-component or combined chemotherapeutic regimens capable of causing severe thrombocytopenia.

C) Patients with THC

Transformation into leukemia or preleukemia: special caution should be exercised in diagnosing severe chronic neutropenia to differentiate it from other hematologic diseases such as aplastic anemia, myelodysplasia and myeloid leukemia. Before the start of treatment, an extensive blood test should be performed to determine the leukocyte formula and the number of platelets, as well as to study the morphological pattern of the bone marrow and karyotype.

A small number (3%) of patients with severe congenital neutropenia (Costman's syndrome) who received Neupogen® had myelodysplastic syndrome (MDS) and leukemia. MDS and leukemia are natural complications of this disease, their connection with treatment with Neupogen ® is unclear. Approximately 12% of patients with initially normal cytogenetics were found to have anomalies during a second examination, including Monosomy 7. If a patient with Costman's syndrome develops cytogenetic disorders, the benefits and risks of continuing Neupogen® therapy should be carefully evaluated. When developing MDS or leukemia Neupogen ® should be discarded. It is not yet clear whether long-term treatment with Neupogen ® predisposes patients with Costman's syndrome to the development of cytogenetic abnormalities, MDS and leukemia. Patients with Costman's syndrome are encouraged to conduct regular (approximately every 12 months) morphological and cytogenetic studies of the bone marrow.

Cytogenetic disorders, leukemia and osteoporosis were detected with prolonged use of Neupogen ® (> 5 years) in patients (9.1%) with severe chronic neutropenia. Their connection with the drug is not clear.

Blood formula: The number of platelets must be carefully monitored, especially during the first few weeks of treatment with Neupogen®. At TCHN during the first weeks of initial therapy, a clinical blood test and the number of platelets are determined 2 times a week, with a stable patient - 1 time per month. If the patient has thrombocytopenia (the number of platelets stably below 100 · 109 / L), the question of temporary withdrawal of the drug or a decrease in dose should be considered. There are also other changes in the blood formula, which require careful monitoring, incl. Anemia and a transient increase in the number of myeloid progenitor cells.

Other: it is necessary to exclude such causes of transient neutropenia as viral infections. The enlargement of the spleen is a direct consequence of the treatment with Neupogen ®. During clinical trials, 31% of patients with TCN showed palpation with splenomegaly. In radiography, the increase in the volume of the spleen is revealed soon after the start of treatment and tends to stabilize. Reducing the dose slows or stops the increase in the size of the spleen; Splenectomy may be required in 3% of patients. The size of the spleen should be monitored regularly by palpation.

A small number of patients had hematuria and proteinuria. To monitor these indicators, urine tests should be done regularly.

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

D) Patients undergoing the mobilization of PMSC

After bone marrow transplantation, a blood test is performed and the platelet count is determined 3 times a week.

Mobilization: a comparison of the two recommended methods of mobilization (only filgrastim or in combination with myelosuppressive chemotherapy) on the same contingent of patients has not been conducted. The choice of the method of mobilization should be made depending on the overall goals of the treatment of the patient.

Prior treatment with cytotoxic drugs: in patients who have undergone active myelosuppressive therapy in the past, there may not be a sufficient increase in PSKK to the recommended minimum level (≥2.0 · 106 CD34 + / kg) or an acceleration in the normalization of platelet count. Some cytotoxic agents have a particular toxicity to the precursor cells of hemopoiesis and can adversely affect their mobilization. The use of melphalan, carboplatin or carmustine together with Neupogen ® is effective when activated by PSKK. If it is planned to transplant PSKK, it is recommended to schedule their mobilization at an early stage of treatment. Particular attention should be paid to the number of progenitor cells activated in such patients before high-dosage chemotherapy. If the results of mobilization, in accordance with the above criteria, are not sufficient, alternative treatments that do not require the use of progenitor cells should be considered.

Estimating the amount ("yield") of peripheral blood stem cells: assessing the number of PSKCs mobilized in patients with Neupogen® should pay special attention to the quantification method. The results of a flow cytometric analysis of the number of CD34 + cells differ depending on the particular methodology and caution should be taken of recommendations based on the number of studies conducted in other laboratories.

There is a complex but stable statistical relationship between the number of CD34 + cells entered into reinfusion and the rate of platelet count normalization after high-dose chemotherapy.

The minimum amount of PSKC, equal to or greater than 2.0 × 10 6 CD34 + cells / kg, results in sufficient hematologic recovery. An amount exceeding this value seems to be accompanied by a faster normalization, a quantity less than that indicated by a slower normalization of the blood picture.

E) Mobilization of PSKC in healthy donors

Procedures for mobilization and apheresis of cells should be conducted in a center with experience in this field. Mobilization of PMSC is possible only if the laboratory parameters, especially the hematological parameters of the donor, match the selection criteria. Transient leukocytosis (leukocytes more than 50 · 109 / l) is noted in 41% of healthy donors, more than 75 · 109 / l - in 2% of healthy donors. Transient thrombocytopenia (the number of platelets less than 100 · 109 / l) after the appointment of filgrastim and the conduct of leukapheresis is observed in 35% of donors. In addition, there were 2 cases of thrombocytopenia less than 50 · 109 / L after the procedure of leukapheresis.

If more than one leukapheresis is required, the number of platelets must be monitored before each apheresis procedure, especially if the platelet count is less than 100 · 109 / L. Conducting leukapheresis is not recommended if the amount of neutrophils is less than 75 · 109 / L, with the appointment of anticoagulants or known hemostasis disorders.

Neupogen® should be withdrawn or its dose should be reduced if the number of leukocytes is more than 70 · 109 / L.

In healthy donors, it is necessary to regularly monitor all blood test parameters prior to their normalization.

Given single cases of rupture of the spleen after the appointment of G-CSF to healthy donors, it is recommended to control its size (palpation, ultrasound).

Long-term monitoring of the safety of Neupogen® in healthy donors continues. There are no data on cases of hemopoiesis disruption in healthy donors up to 4 years after the administration of Neupogen®. However, it is recommended in the apheresis center to systematically monitor the long-term safety of the drug in healthy donors.

Specific guidance for recipients of allogeneic PSKK obtained with Neupogen®

The use of an allogeneic graft may be associated with increased risk of developing an acute or chronic "graft versus host" response compared to bone marrow transplantation.

Neutropenia in HIV patients

In the treatment of Neupogen ®, a thorough blood test (ACN, erythrocytes, platelets, etc.) should be performed on a daily basis for the first few days, then 2 times a week for the first 2 weeks and every week or one week during maintenance therapy. Taking into account fluctuations in the value of DCC, in order to determine the true maximum decrease in ACN (nadir), blood sampling should be performed before the next dose of the drug is prescribed.

In patients with infectious diseases and infiltration of bone marrow with infectious agents (for example, the Mycobacterium avium complex) or with bone marrow (lymphoma) tumor, therapy with filgrastim is carried out simultaneously with therapy directed against these conditions.

G) Other special precautions

Patients with sickle-cell anemia should regularly perform a blood test and take into account the possibility of developing splenomegaly and thrombosis of blood vessels.

Patients with bone pathology and osteoporosis receiving continuous treatment with Neupogen® for more than 6 months are shown to control bone density.

The effect of Neupogen in patients with a significantly reduced number of myeloid progenitor cells is not known. Neupogen® increases the number of neutrophils by primarily affecting neutrophil precursor cells. Therefore, in patients with a reduced content of progenitor cells (for example, those subjected to intensive radiation therapy or chemotherapy), the degree of increase in the number of neutrophils may be lower.

Neupogen® contains sorbitol at a concentration of 50 mg / ml, caution should be exercised in patients with hereditary fructose intolerance.

If a respiratory distress syndrome occurs in adults, the drug should be discontinued and appropriate treatment prescribed.

Influence on ability to drive vehicles and work with machines and mechanisms. No influence of Neupogen has been observed on the ability to drive a car or work with mechanisms.

Storage conditions of the drug Neupogen

At a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug Neupogen

2 years.

Do not use after the expiry date printed on the package.

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