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 testosterone cypionate price 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 Neupogen ® . 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 , 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 statistical relationship between the number entered in the CD34 + cells and infusing rate of normalization of the platelet count after high-dose chemotherapy.
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.
Testosterone cypionate price 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.
e) Neutropenia in HIV patients
With a very quick positive response to therapy possible a significant increase in the number of neutrophils after administration of the initial doses of Neupogen ® . In drug treatment, Neupogen ® need to perform regular full blood count (ANC, the number of red blood cells, platelets, etc.) daily for the first 2-3 days, then two times a week for the first 2 weeks, and every week or every other week in during maintenance therapy. During testosterone cypionate price the maintenance therapy of 300 mg per day for alternating pattern may be significant fluctuations in the number of neutrophils. Given the fluctuations ANC values, to determine the true maximum reduction of ANC (nadir) blood sampling should be carried out before the appointment of the next dose of the drug.
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) or more in a combination therapy, 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.
In patients with infectious diseases and bone marrow infiltration of infectious agents (eg, complex Mycobacterium avium) or a tumor of bone marrow lesions (lymphoma) filgrastim therapy is carried out simultaneously with the therapy directed against these states. The effectiveness of in the treatment of neutropenia caused by bone marrow infiltration of infectious agents (osteomyelitis) or tumor lesion has not been established.
g) Other special precautions
Described isolated cases of splenic rupture in healthy donors and patients with cancer in patients receiving G-CSF (filgrastim) in some cases fatal. Given these data, it is recommended to closely monitor the size of the spleen by clinical examination (palpation) and instrumental methods (eg, ultrasound). It is necessary to carry out aiming diagnosis of suspected ruptured spleen or splenomegaly in the case of complaints of patients or healthy donors of pain in the upper left quadrant of the abdomen or upper shoulder area.
According to the literature, the presence of sickle-cell anemia, and high white blood cell count is a poor prognostic factor. These patients should be regularly carry out blood tests and take into account the possibility of splenomegaly and thrombosis. There are cases of sickle cell crises in patients receiving filgrastim, some – with fatal consequences. Therefore, in patients with sickle cell disease need to be careful in appointing , carefully evaluate the benefits and possible risks.
Patients with bone disease and osteoporosis receiving continuous treatment with for more than 6 months, shows the control of the density of the bone substance.
Action patients with significantly reduced amount of unknown myeloid progenitor cells. 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., undergoing intensive chemotherapy or radiotherapy), the degree of increase in the number of neutrophils can be lower.
Action Neupogen ® the reaction “graft versus host” is not set.
Neupogen ® contains sorbitol in a concentration of 50 mg / ml. It is unlikely that as a result of monotherapy in the body goes a sufficient amount of sorbitol to develop toxic reactions, however, patients with hereditary fructose intolerance should be careful.
At occurrence of symptoms such as cough, dyspnea, fever, and, in combination with radiological data using the presence of pulmonary infiltrates, and deterioration of pulmonary function, can include developing adult respiratory distress syndrome. In this case, drug therapy should be discontinued and appropriate treatment.
Instructions for use, handling and disposal
You should avoid vigorous shaking.
Before the introduction of the solutiontestosterone cypionate price should be inspected for the presence of foreign visible particles. It allowed the introduction of the solution but without the presence of foreign visible particles.
Vials and syringe-tubes of the drug are intended for single use only.
Contact drugs to the environment should be minimized. Do not dispose of Neupogen ® via wastewater or with household waste. If possible, a special system for the disposal of drugs should be used.
Overdose cases are not marked. In bone marrow transplantation studies in patients Neupogen ® was administered at doses up to 138 mcg / kg per day without developing the toxic effects. After 1-2 days after discontinuation of the drug the number of circulating neutrophils is usually reduced by 50% and returns to normal 1-7 days.