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Rticular attention should be paid to the differential diagnosis between acute myeloid leukemia and blast crisis of chronic myeloid leukemia.Human G-CSF can promote growth of myeloid cells in vitro. Similar effects can be observed in vitro and in relation to certain non-myeloid cells.

It should be used with caution cypionate testosterone in patients with secondary AML, due to the limited data on the safety and efficacy in this case.

The safety and efficacy of  in patients with acute myeloid leukemia de novo under the age of 55 years in case of favorable cytogenetic prognostic factors (translocation t (8; 21), t (15; 17), inv (16)) have not been established.

b) Patients receiving cytotoxic chemotherapy

Leukocytosis: less than 5% of patients receiving at doses more than 0.3 million units (3 mg / kg per day), the number of leukocytes was increased to 100 x 10 9 / L or more. There were no adverse events directly related with leukocytosis, not described. However, given the potential risks associated with high leukocytosis, during treatment with should regularly (eg, 2-3 times a week) to determine the number of leukocytes. If, after passing the expected minimum number of leukocytes than 50 x 10 9 / L,  should be discontinued immediately. If Neupogen ® used to mobilize PBSC, the dose should be reduced or completely canceled in the case where the number of cells exceeds 70 x 10 9 / L.

The risk associated with high-dose chemotherapy: particular caution should be exercised when treating patients receiving high-dose chemotherapy, because improved outcome of cancer were observed, while the chemotherapeutic agents higher doses have a more severe toxicity, including skin reactions and side effects to the cardiovascular , nervous and respiratory systems (see. the instructions for use of specific chemotherapeutic agents).

Monotherapy drug  does not prevent anemia and thrombocytopenia caused by 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 thrombocytopenia and anemia. It is recommended to conduct regular blood tests and to determine platelet count and hematocrit.Particular caution should be exercised when using single-component or combination chemotherapeutic regimens known to cause severe thrombocytopenia.

It has been shown that the use of  to mobilize PBSC reduces the extent and duration of thrombocytopenia, which developed as a result of myelosuppressive or myeloablative chemotherapy.

c) Patients with TXH

Transformation to leukemia or predleykoz (myelodysplastic syndrome): particular caution should be exercised in diagnosing TXH, and differentiate it from other hematologic disorders such as aplastic anemia, myelodysplasia, and myeloid leukemia. Prior to treatment should be carried out a detailed analysis of blood with determination of leukocyte and platelet counts, as well as to explore the morphological picture of the bone marrow and karyotype.

A small number (3%) of patients with severe congenital neutropenia (Kostmann’s syndrome) treated with  , observed myelodysplastic syndrome and leukemia. Myelodysplastic syndrome and leukemia – natural complications of the disease. Their connection with the treatment of drug unclear. Approximately 12% of patients with normal cytogenetics when re-examination detected abnormalities, including monosomy 7. If a patient with the syndrome Kostmann appear cytogenetic violations, it is necessary to carefully evaluate the benefits and risks of continuing therapy with. With the development of myelodysplastic syndrome or leukemia  should be discontinued. It is not yet clear whether long-term treatment predisposes drug cypionate testosterone in patients with severe congenital neutropenia (Kostmann’s syndrome) to the development of cytogenetic abnormalities, myelodysplastic syndrome and leukemia. Patients with the syndrome Kostmann is recommended at regular intervals (approximately every 12 months.) To carry out the morphological and cytogenetic studies of bone marrow.

Cytogenetic disorders, leukemia and osteoporosis have been found long-term use of the drug Neupogen ® (> 5 years) patients (9.1%) with TXH. Communication of these phenomena with the use of the drug is not clear.

Blood formula: you need to carefully monitor the number of platelets, especially during the first few weeks of treatment with  . When TXH during the first weeks of therapy, the initial blood count and platelet count is determined two times per week, with a steady state of the patient – 1 time per month. If the patient has thrombocytopenia (platelet count consistently below 100 x 10 9 / l), should be considered a temporary drug discontinuation or dose reduction. There are also other changes in blood counts, requiring careful control it, including anemia and transient increase in the number of myeloid progenitor cells.

Others: to exclude causes of transient neutropenia, such as viral infections. Enlargement of the spleen is a direct consequence of treatment with  . In clinical studies 31% of patients with TXH palpation detected splenomegaly. When X-ray is detected increase shortly after the beginning of treatment and tends to stabilize. Dose reduction slows or stops increasing the size of the spleen; splenectomy may require 3% of patients. Spleen dimensions must be controlled regularly by palpation.

A small number of patients had hematuria and proteinuria. To monitor these indicators should regularly do a urine test.

The safety and efficacy of the drug in neonates and patients with autoimmune neutropenia have not been established (see. Section “Features of the application of the drug in pregnant women, women during the period of breastfeeding, children and adults with chronic diseases”).

g) patients undergoing PBSC mobilization

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

Mobilization: comparison of the two recommended mobilization methods (filgrastim alone or in combination with myelosuppressive chemotherapy) on the same cohort of patients was conducted. A direct comparison of the results of different studies is difficult because of individual differences between patients, and because of the differences between the values of CD34 +, obtained by laboratory analyzes.Therefore difficult to recommend any best method of mobilization. Selection of mobilization method should be carried out according to the common goals of patient therapy.

Previous treatment with cytotoxic drugs: patients who in the past was carried out active myelosuppressive therapy, sufficient increase PSCC can not take place before the recommended minimum level (³ 2.0 x 106 CD34 + / kg) or acceleration of normalization of platelet count.

Certain cytotoxic agents have specific toxicity towards hematopoietic progenitor cells and may adversely affect their mobilization. The use of drugs such as melphalan, carmustine, carboplatin, and over an extended period prior to mobilization may reduce its degree of severity. However, the use of melphalan, carboplatin or carmustine with the drug Neupogen ® is effective in activating PSCC. If you plan to PBSC transplantation, it is recommended to plan their mobilization in the early stages of treatment. Particular attention should be paid to the number of progenitor cells activated in such patients to high-dose chemotherapy. If mobilization results in accordance with the above criteria are not sufficient to consider alternative treatment not requiring the use of progenitor cells.

Evaluation of the number ( “Harvest”), peripheral blood stem cells: estimating the number of PBSC mobilized in patients using Neupogen ® , should be paid special attention to the method of quantitation. The results of flow cytometric analysis of CD34 + cell numbers vary depending on the particular methodology, and should be wary of recommendations according to their number, based on studies in other laboratories.

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

Minimum number PSCC equal to or greater than 2.0 x 106 of CD34 + cells / kg, resulting in the restoration of adequate hematological parameters. The amount exceeding this value appears to be accompanied by a more rapid normalization of the number of said at least – a slower normalization of the blood picture.

d) Mobilization of TUAC in healthy donors

PBSC mobilization procedure shall not be of direct benefit to normal donors and should only be undertaken with a view to allogeneic transplantation.

mobilization and apheresis procedures should be carried out of cells in the medical center, which has experience in this area. Mobilization of TUAC is possible only if the appropriate laboratory parameters, especially hematologic donor performance, selection criteria, and special attention should be paid to the presence of infectious disease (see. Section “Peculiarities of use of the drug by pregnant women, women during the period of breastfeeding, children and adults with chronic illness “).

Transient leukocytosis (white blood cells more than 50 x 10 9 / L) was observed in 41% of healthy donors. Transient thrombocytopenia (platelet count less than 100 x 10 9 / L) after administration of filgrastim and leukapheresis conduct is 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. Carrying leukapheresis it is not recommended if the platelet count less than 75 x 10 9 / l, with the appointment of anticoagulants or known violations of hemostasis.

should be discontinued or the dose should be reduced if the leukocyte count 70 x 10 9 / L.

In healthy donors, all indicators of a blood test before their normalization should be regularly monitored.

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

We can not exclude the risk of a clone of malignant tumor cells. In apheresis center recommended systematic monitoring of long-term safety of the drug in healthy donors.

Evaluation of the safety and efficacy of the drug Neupogen ® in healthy donors younger than 16 and older than 60 years has not been evaluated.

Specific guidance for recipients of allogeneic PBSC obtained using Neupogen ®

The use of allogeneic transplant PSCC may be associated with an increase in the risk of acute or chronic reaction “graft versus host” compared with bone marrow transplantation.

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