Universal reference book for medicines
Product name: TEVAGRASTIM (TEVAGRASTIM)

Active substance: filgrastim

Type: Leukopoiesis stimulant

Manufacturer: Teva Pharmaceutical Industries (Israel) manufactured by LEMERY (Mexico)
Composition, form of production and packaging
The solution for the / in and / or the introduction of a
transparent, colorless.

1 ml 1 syringe

filgrastim 60 million ED 30 million units

[PRING] glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, water d / u.

0.5 ml - disposable syringes (1) - cardboard packs.

0.5 ml - disposable syringes (5) - cardboard packs.

0.5 ml - disposable syringes (10) - packs of cardboard.

0.5 ml - disposable syringes (1) with safety device needles - packs cardboard.

0.5 ml - disposable syringes (5) with safety device needles - packs cardboard.

0.5 ml - disposable syringes (10) with safety device needles - packs cardboard.

The solution for the / in and / or the introduction of a transparent, colorless.

1 ml 1 syringe

filgrastim 60 million ED 48 million ED

[PRING] glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, water d / u.

0.8 ml - disposable syringes (1) - cardboard packs.

0.8 ml - disposable syringes (5) - cardboard packs.

0.8 ml - disposable syringes (10) - cardboard packs.

0.8 ml - disposable syringes (1) with safety device needles - packs cardboard.

0.8 ml - disposable syringes (5) with safety device needles - packs cardboard.

0.8 ml - disposable syringes (10) with safety device needles - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2012.

PHARMACHOLOGIC EFFECT

Leukopoiesis stimulant.
Filgrastim is a highly purified non-glycosylated protein consisting of 175 amino acids. It is produced by the strain Escherichia coli , into the genome of which the gene of granulocyte colony-stimulating factor of a person 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.
Filgrastim, containing recombinant G-CSF, significantly increases the number of neutrophils in 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, filgrastim may cause a slight increase in the number of circulating eosinophils and basophils.
Filgrastim 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. Filgrastim 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 filgrastim and cytotoxic chemotherapy require smaller doses of antibiotics compared to patients receiving only cytotoxic chemotherapy.

Treatment with filgrastim 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.

Application filgrastima both independently and after chemotherapy, mobilizes the yield of hematopoietic stem cells in 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 peripheral blood stem cells can also be administered after (high-dose) myelosuppressive cytotoxic therapy. The use of peripheral blood stem cells mobilized with filgrastim accelerates the restoration 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 filgrastim in adults and children receiving cytotoxic chemotherapy are the same.

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

The appointment of filgrastim to patients with HIV infection allows maintaining normal neutrophil levels and following recommended doses of antiretroviral and / or other myelosuppressive therapy.
There are no signs of an increase in HIV replication with filgrastim.
Like other hematopoietic growth factors, the granulocyte colony stimulating factor stimulates human endothelial cells in vitro.

PHARMACOKINETICS

Distribution

With iv and n / k administration of filgrastim a positive linear relationship between the administered dose and serum concentration is observed.
After sc administration of therapeutic doses, its concentration exceeds 10 ng / ml for 8-16 hours. V d is 150 ml / kg.
Excretion

Regardless of the mode of administration, the elimination of filgrastim proceeds according to the rules of first-order kinetics.
T 1/2 - 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 result in cumulation and an increase in T 1/2 .

Pharmacokinetics in special clinical cases

In patients with end-stage renal failure, an increase in C max and AUC and a decrease in V d and clearance are observed compared with healthy volunteers and patients with moderate-level renal failure.

INDICATIONS

- 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, incl.
after myelosuppressive therapy;
- Severe congenital, periodic or idiopathic neutropenia (absolute number of neutrophils (ACHN) ≥ 0.5 × 10 9 / L) in children and adults with severe or recurrent infections in the anamnesis;

- persistent neutropenia (ACHN 1.0 × 10 9 / L) in patients with developed stage of HIV infection to reduce the risk of bacterial infections when other methods of treatment are not possible.

DOSING MODE

The drug is administered daily s / c or in the form of short intravenous infusions (30-minute) in a 5% dextrose solution 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 after the route of administration. If necessary, in / in the introduction of the required amount of the drug is injected from the syringe into a vial or plastic container with 5% dextrose, then a 30-minute infusion of the diluted drug is made. Syringes with Tevagrastim are intended for single use only.
Rules of breeding

The drug Tevagrastim is diluted only with 5% dextrose solution, it is impossible to dilute with 0.9% sodium chloride solution.
The diluted drug can be adsorbed by glass and plastics. If the drug is diluted to a concentration of less than 15 μg / ml (less than 1.5 million IU / ml), then serum albumin should be added to the solution so that the final concentration of albumin is 2 mg / ml. For example, with a final solution volume of 20 ml, a total dose of Tevagrastim less than 300 μg (less than 30 million ME) should be administered with the addition of 0.2 ml of a 20% human albumin solution. Tevagrastim can not be diluted to a final concentration of less than 2 μg / ml (less than 0.2 million IU / ml).
The ready-made solution of the drug Tevagrastim should be stored at a temperature of 2 ° to 8 ° C for no more than a day.

Standard schemes of cytotoxic chemotherapy

Enter a dose of 5 μg (0.5 million IU) / kg 1 time / day daily sc, or iv in the form of short infusions (30-minute) in a 5% solution of dextrose.
The first dose of the drug is administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy. If necessary, the duration of the course of therapy can be up to 14 days, depending on the severity of the disease and the severity of neutropenia. After induction and consolidation therapy of acute myelogenous leukemia, the duration of the drug Tevagrastim may increase up to 38 days, depending on the type, dosage and the used scheme of cytotoxic chemotherapy.
A transient increase in the number of neutrophils is usually observed 1-2 days after the beginning of treatment with Tevagrastim.
To achieve a stable therapeutic effect, it is necessary to continue therapy with Tevagrastim until the number of neutrophils passes the expected minimum and does not reach normal values.
It is not recommended to cancel the drug Tevagrastim prematurely, until the number of neutrophils passes through the expected minimum.
Treatment should be discontinued if the AFC after nadir reached 1.0 × 10 9 / L.
After myeloablative chemotherapy followed by bone marrow transplantation

Enter the SC or IV in the form of infusion in 20 ml of a 5% solution of dextrose.
The initial dose of 10 μg (1.0 million IU) / kg iv drip for 30 minutes or 24 hours, or by continuous infusion for 24 hours. The first dose of Tevagrastim should be administered no earlier than 24 hours after cytotoxic chemotherapy, and for bone marrow transplantation - no later than 24 hours after the infusion of the bone marrow. The duration of therapy is no more than 28 days. After the maximum reduction in the number of neutrophils (nadir), the daily dose is adjusted depending on the dynamics of their number. If the content of neutrophils in peripheral blood exceeds 10 × 10 9 / L for three consecutive days, the dose of Tevagrastim is reduced to 5.0 μg (0.5 million IU) / kg; then, if ACCH exceeds 1.0 × 10 9 / L for three consecutive days, Tevagrastim is withdrawn. If, during the treatment period, AHS decreases less than 1.0 × 10 9 / l, the dose of Tevagrastim is 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

Enter a dose of 10 μg (1.0 million IU) / kg by injection 1 time / day or a continuous 24-hour infusion for 6 consecutive days, with two leukapheresis procedures in a row at the 5th, 6th days.
In some cases, additional leukapheresis is possible. The appointment of the drug Tevagrastim must continue until the last leukapheresis.
Mobilization of PSKC after myelosuppressive therapy

Enter a dose of 5 μg (0.5 million IU / kg) 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 number of neutrophils rises from less than 0.5 × 10 9 / L to more than 5.0 × 10 9 / 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

Enter a dose of 10 mcg (1.0 million AD) / kg / day p / c, for 4-5 days.
Leukapheresis is carried out from day 5 and, if necessary, until day 6 in order to obtain CD34 + cells in an amount of at least 4 × 10 6 cells / kg of body weight of the recipient. The efficacy and safety of the drug Tevagrastim in healthy donors under the age of 16 and older than 60 years have not been investigated.
Severe chronic neutropenia (THC)

Enter daily s / to, once or divided into several introductions.
With congenital neutropenia, the initial dose of 12 μg (1.2 million IU) / kg / day, with idiopathic or periodic neutropenia - 5 μg (0.5 million IU) / kg / day, to a stable excess of the number of neutrophils 1.5 × 10 9 / l. After achieving the therapeutic effect, the minimum effective dose should be determined to maintain this level of neutrophils. 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, you can make a dose adjustment to maintain the number of neutrophils in the range of 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 the treatment, the full therapeutic effect is observed when prescribing doses of filgrastim up to 24 mcg / kg / day. The daily dose of Tevagrastim should not exceed 24 mcg / kg.
Neutropenia in HIV infection

The initial dose of 1-4 μg (0.1-0.4 million MIU) / kg / day once p / to the normalization of the number of neutrophils (not less than 2 × 10 9 / l).
Normalization of the number of neutrophils usually occurs in 2 days. After reaching the therapeutic effect, a maintenance dose of 300 mcg / day 2-3 times a week according to the alternating schedule (every other day). In the future, individual dose adjustment and long-term therapy with Tevagrastim may be required to maintain a neutrophil count of more than 2.0 × 10 9 / L.
Dosing in special clinical cases

For elderly patients, there are no special recommendations for dosing.

In children with severe chronic neutropenia and oncological diseases, the profile of filgrastim safety did not differ from that in adults.
Recommendations for dosing for children 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.

SIDE EFFECT

General disorders and reactions at the site of administration: headache, fatigue, reactions at the injection site (less than 2% of patients with TCN).

From the musculoskeletal system: pain in the
bones and muscles (often - weak or moderate, infrequently - strong, which in most cases are stopped by usual analgesics), arthralgia, osteoporosis, acute gouty arthritis, exacerbation of rheumatoid arthritis.
From the digestive system: diarrhea, constipation, anorexia, hepatomegaly.

From the side of the cardiovascular system: very rarely - transient arterial hypotension, which does not require medical correction, skin vasculitis (with long-term therapy in 2% of patients with TCN), arrhythmias (connection with filgrastim is not established), vascular disorders (veno-occlusive disease, with reception filgrastima it is not established or installed).

On the part of the respiratory system: sore throat, lung infiltrates, adult respiratory distress syndrome, respiratory failure, interstitial pneumonia, possibly with an unfavorable prognosis (after chemotherapy).

Dermatological reactions: often - alopecia, skin rash, pain at the injection site;
rarely - Sweet syndrome (acute febrile neutrophilic dermatosis, connection with filgrastim is not established).
From the hemopoietic and lymphatic system: infrequently - splenomegaly, pain in the upper left quadrant of the abdomen;
rarely - thrombosis of blood vessels; spleen rupture, thrombocytopenia, anemia and nasal bleeding (with long-term administration), myelodysplastic syndrome and leukemia (in 3% of patients with severe congenital neutropenia (Costman's syndrome).) Less than 5% of patients receiving filgrastim in doses above 3 μg 0.3 million IU) / kg / day, hyperleukocytosis was observed (an increase in the number of leukocytes in excess of 100 × 10 9 / L) .Adverse effects directly associated with filgrastim induced hyperleukocytosis are not described.
On the part of the genitourinary system: proteinuria, hematuria, mild or moderate dysuria.

Allergic reactions: rarely - rashes, hives, angioedema.
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.
On the part of laboratory indicators: reversible, dose-dependent (usually mild or moderate) increase in LDH activity, APF, and GGT, hyperuricemia, transient hypoglycemia after eating;
very rarely - proteinuria, hematuria.
CONTRAINDICATIONS

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

- use of the drug in order to increase the doses of cytotoxic chemotherapeutic drugs above recommended;

- simultaneous appointment with cytotoxic chemo- and radiotherapy;

- terminal stage of chronic renal failure;

- the period of lactation (breastfeeding);

- Newborn age (up to 28 days of life);

- Hypersensitivity to filgrastimu or other components of the drug.

With caution should be used during pregnancy, malignant and premalignant disorders of myeloid character (including acute myelogenous leukemia), sickle cell anemia, in combination with high-dose chemotherapy, hereditary fructose intolerance.
PREGNANCY AND LACTATION

Safety of filgrastim in pregnant women has not been established. Perhaps the passage of filgrastim the placenta in women. When assigning pregnant filgrastim should be related to the expected therapeutic effect of the possible risk to the fetus.
No data on the penetration of filgrastim in breast milk. Apply filgrastim during breastfeeding is not recommended.
APPLICATION FOR FUNCTIONS OF THE LIVER

Filgrastim dose adjustment is required in patients with severe renal or hepatic impairment , as their pharmacokinetic and pharmacodynamic parameters are similar to those in healthy volunteers.
Patients with end-stage renal disease the drug is contraindicated.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Filgrastim dose adjustment is required in patients with severe renal or hepatic impairment , as their pharmacokinetic and pharmacodynamic parameters are similar to those in healthy volunteers.
APPLICATION FOR CHILDREN

In children with severe chronic neutropenia and cancer safety profile of filgrastim did not differ from that of adults. Dosing recommendations for children's age are the same as for adults receiving myelosuppressive cytotoxic chemotherapy or.
APPLICATION IN ELDERLY PATIENTS

For elderly patients a special dosing recommendations are not available.
SPECIAL INSTRUCTIONS

Treatment with Tevagrastim should only be done under the supervision of an oncologist or hematologist with experience in the use of G-CSF, with the necessary diagnostic capabilities. mobilization and apheresis procedures should be performed in the cell oncology and hematology center with experience in this field and the possibility of adequate monitoring of hematopoietic progenitor cells.
Syringe, in which the solution can be equipped with an additional safety device to be needles or without it. Additional safety device designed to prevent injuries and shots already used syringes (needles) and does not require any special precautions. For the introduction of the solution necessary to press slowly and evenly on the syringe plunger. The pressure on the piston to retain the introduction of the recommended dose and removal of the syringe from the injection site. Used syringes disposed of in accordance with the instructions of the medical institution or a doctor. Syringes without the safety device before discarding placed in a container made of durable material.
The growth of malignant cells
When myelodysplastic syndrome (MDS), chronic myeloid leukemia, and efficacy and safety of filgrastim not established. For patients with the above diseases as well as precancerous lesions of the myeloid lineage of hematopoiesis, application filgrastim not shown. Particular attention should be paid to the differential diagnosis between the blast crisis of chronic myeloid leukemia and acute myeloid leukemia. Human G-CSF can promote growth of myeloid cells in vitro . Similar effects can be observed in vitro and in respect of certain non-myeloid cells.
Patients with TXH
Particular caution should be exercised in the diagnosis TXH to differentiate it from other hematologic disorders such as aplastic anemia, myelodysplasia, and myeloid leukemia. In 3% of patients with severe congenital neutropenia (Kostmann syndrome), treated with filgrastim observed MDS and leukemia. MDS and leukemia - natural complications of the disease; but their relationship to filgrastim treatment is not established. Approximately 12% of patients with normal cytogenetics when re-examination detected anomalies, including monosomy 7. If the patient with severe congenital neutropenia (Kostmann syndrome) appear cytogenetic abnormalities, as well as the development of MDS or leukemia, filgrastim should be canceled. It is not yet clear,predisposes whether long-term treatment of filgrastim in patients with severe congenital neutropenia (Kostmann's syndrome) to the development of cytogenetic abnormalities, MDS and leukemia. However, such patients are advised at regular intervals (approximately every 12 months) to conduct morphological and cytogenetic studies of bone marrow. Cytogenetic abnormalities, leukemia and osteoporosis have been found long-term use of filgrastim (over 5 years) in 9.1% of patients with TXH. Their connection with the drug intake is not clear.leukemia and osteoporosis have been found long-term use of filgrastim (over 5 years) in 9.1% of patients with TXH. Their connection with the drug intake is not clear.leukemia and osteoporosis have been found long-term use of filgrastim (over 5 years) in 9.1% of patients with TXH. Their connection with the drug intake is not clear.
Patients receiving cytotoxic chemotherapy
have a small number of patients (less than 5%) treated with filgrastim at doses higher than 3 mg (0.3 mln.ME) / kg / day was observed hyperskeocytosis (increasing the number of leukocytes than 100? 10%). Side effects directly related to induced filgrastim hyperskeocytosis not described. However, given the potential risks associated with hyperleukocytosis during treatment with filgrastim should be regular monitoring of the number of leukocytes. If, after the passage of the expected wage is above 50 × 10 9 / L, filgrastim should be discontinued immediately. In the case of filgrastim mobilization of hematopoietic stem cells, the drug must be canceled when the number of cells exceeds 70 × 10 9 / l.
Particular caution should be exercised in the treatment of patients receiving high-dose chemotherapy, as higher doses of chemotherapeutic agents have a more pronounced toxicity, including skin reactions and side effects of cardiovascular, nervous and respiratory systems.
Monotherapy filgrastim did not prevent the development of thrombocytopenia and anemia due to myelosuppressive chemotherapy. Because of the potential application of higher doses of chemotherapy (eg full doses in accordance with the schemes), the patient may be at greater risk of developing thrombocytopenia and anemia. It is recommended to regularly twice a week to carry out a blood test to determine platelet count and hematocrit in the application of filgrastim after chemotherapy. Particular caution should be exercised when applying single-component or combination chemotherapeutic regimens known to cause severe thrombocytopenia.
It is necessary to carefully monitor the number of platelets, especially during the first few weeks of treatment with filgrastim. When TXH during the first weeks of therapy initial CBC and platelet counts determined two times per week, at a stable condition of the patient - 1 time per month. If a patient develops thrombocytopenia (platelet count consistently below 100 × 10 9 / l), should be considered a temporary drug discontinuation or dose reduction. There are also other changes in blood counts, requiring careful control, including anemia and transient increase in the number of myeloid progenitor cells. It is necessary to eliminate the causes of transient neutropenia, such as viral infections.
Enlargement of the spleen is a direct consequence of the treatment of filgrastim. In clinical studies 31% of patients with TXH palpation detected splenomegaly. When radiography revealed splenomegaly amount shortly after the start of treatment and tends to stabilize. Dose reduction slows or stops the increase in spleen size; 3% of patients may require splenectomy. The spleen must be controlled regularly by palpation. A small number of patients had hematuria and proteinuria. To control these indicators should make regular urinalysis.
Safety and efficacy of filgrastim in neonates and patients with autoimmune neutropenia have not been established.
Patients undergoing PBSC mobilization
After bone marrow transplantation carried out blood and platelet counts determined 3 times a week.
Comparison of the two recommended mobilization methods (filgrastim alone or in combination with myelosuppressive chemotherapy) for the same cohort of patients was conducted. Selection mobilization method should be performed depending on the overall objectives of the treatment of the patient.
In patients who in the past been actively pursued myelosuppressive therapy, a sufficient increase PSCC can not take place before the recommended minimum (at least 2.0 × 10 6CD34 + cells / kg) or acceleration of normalization of platelet counts. Some cytotoxic agents exhibit particular toxicities with respect to progenitor cells of hematopoiesis and may adversely affect their mobilization. If you plan to PBSC transplantation, it is recommended to plan their mobilization in the early stages of treatment. If as a result of the mobilization could not get enough of the PBSC, you should consider alternative treatments that do not require the use of progenitor cells.
Estimating the number of PBSC mobilized by patients using filgrastim, particular attention should be paid to the method of quantitation. The results of flow cytometric analysis of CD34 + cells vary depending on the specific methodology and need to be wary of recommendations according to their number, based on studies in other laboratories.
There is a complex but stable statistical relationship between the number of introduced CD34 + cells and number of platelets normalization rate after high-dose chemotherapy.
Minimum number PSCC equal to or greater than 2 × 10 6CD34 + cells / kg, leads to sufficient hematological recovery. Number PSCC exceeding this value appears to be accompanied by more rapid normalization PSCC amount less than the specified value, followed by a slower normalization of the blood picture.
PBSC mobilization in normal donors,
mobilization and apheresis procedures should be carried out cells in the heart, which has experience in this area. PBSC Mobilization only possible provided appropriate laboratory settings, particularly hematological parameters donor selection criteria. Transient leukocytosis (leukocytes more than 50 x 10 9 / L) was observed in 41% of healthy donors, a 75 × 10 9/ l - 2% of healthy donors. Transient thrombocytopenia (platelet count of less than 100 x 10 9 / l) after administration of filgrastim and leukapheresis observed in 35% of donors. In addition, 2 cases of thrombocytopenia less than 50 x 10 9 / l after leukapheresis procedure.
If required more than one conducting leukapheresis necessary to control the platelet count before each apheresis procedure, particularly if the platelet count below 100 x 10 9 / l. Undergo leukapheresis is not recommended if the platelet count is less than 75 × 10 9/ l, for administration of anticoagulants or known disorders of hemostasis. Filgrastim should be discontinued or the dose should be reduced if the leukocyte count 70 x 10 9 / l.
In healthy donors, all parameters of blood analysis to their normalization must be checked regularly.
Given the isolated cases of splenic rupture after administration of G-CSF from healthy donors, it is recommended to control its size (palpation, ultrasound).
It continues for a long security monitoring application of filgrastim in healthy donors. No data on cases of violation of hematopoiesis in healthy donors up to 4 years after the appointment of filgrastim. However, in the center of apheresis recommended systematic monitoring of long-term safety of filgrastim in healthy donors.
When allogeneic PBSC risk of acute or chronic reaction "graft versus host" higher than in allogeneic bone marrow transplantation.
Neutropenia in HIV-patients
When treating filgrastim need to perform regular full blood count (absolute neutrophil count (ANC), erythrocytes, platelets, etc.) daily for the first few days, then two times a week for the first 2 weeks, every week or every other week in during maintenance therapy. Considering fluctuations ANC values to determine the true maximum reduction of ANC (nadir) blood sampling should be carried out before assigning the next dose. Patients with infectious diseases and bone marrow infiltration of infectious agents (e.g., complex Mycobacterium avium) or tumorous lesions of the bone marrow (lymphoma) filgrastim therapy is performed simultaneously with therapy directed against these conditions.
Other special precautions
Patients with sickle cell disease should regularly carry out a blood test and consider the possibility of splenomegaly and thrombosis.
Patients with bone disease and osteoporosis receiving filgrastim continuous treatment for more than 6 months, the bone density shows a control substance.
Effect of filgrastim in patients with severely reduced the number of myeloid progenitor cells is not known. Filgrastim increases the number of neutrophils by acting primarily on precursor cells of neutrophils. Therefore, in patients with a reduced content of progenitor cells (e.g., exposed to intensive radiation therapy or chemotherapy), the degree of increase in the number of neutrophils can be lower.
In the event of respiratory distress syndrome, adult treatment drug should be discontinued and appropriate treatment.
Contained in the product Tevagrastim sorbitol in an amount of 50 mg / ml should not adversely affect the patients with hereditary fructose intolerance. However, drug use Tevagrastim in these patients with caution.
Impact on the ability to drive vehicles and manage mechanisms

There was no effect of filgrastim on ability to drive and use machines.
OVERDOSE

Cases of filgrastim overdose are not marked. After 1-2 days after the drug is usually the number of circulating neutrophils is reduced by 50% and returns to normal after 1-7 days.
DRUG INTERACTION

The efficacy and safety of filgrastim administration in one day with cytotoxic chemotherapy have not been established. Due to the high sensitivity of actively proliferating myeloid cells to cytotoxic anticancer drugs assign filgrastim for 24 hours before or after administration of these drugs is not recommended.
Fluorouracil increases the severity of neutropenia, while the appointment with filgrastim. Possible interactions with other hematopoietic growth factors and cytokines is unknown.
Given that lithium promotes the release of neutrophils, may increase filgrastim action when combined appointment, but such studies have not been conducted.
Filgrastim pharmaceutically incompatible with 0.9% sodium chloride solution. In the application of filgrastim mobilization of hematopoietic stem cells after the chemotherapy should be noted that when administered for a long time cytostatics such as melphalan, carmustine and carboplatin, mobilization efficiency may be reduced.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be protected from light, reach of children at a temperature of from 2 ° to 8 ° C.
Shelf life - 2.5 years.
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