The active ingredient of the drug is filgrastim – recombinant human granulocyte colony stimulating factor (G-CSF). Filgrastim has the same biological activity as the endogenous human G-CSF, and differs from the latter only in that it is a non-glycosylated protein with additional N-terminal methionine residue. Filgrastim, testosterone cypionate results produced by recombinant DNA technology, cells vdelyayut of bacteria Escherichia coli, into the genetic system which introduced a gene encoding a protein G-CSF.
Filgrastim stimulates the formation of functionally active neutrophils and output to peripheral blood from bone marrow is used to treat patients with neutropenia of various origins.
As with intravenous and subcutaneous administration of filgrastim there is a positive linear relationship between its serum concentration dose. The volume of distribution in the blood is approximately 150 ml / kg.
Filgrastim continuous infusion over a period of 28 days to patients after autologous bone marrow transplantation is not accompanied by signs of accumulation and increase in half-life.
Indications for use.
- Neutropenia, febrile neutropenia, due to myelosuppressive cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndrome) in order to shorten the period of neutropenia and febrile neutropenia.
- Neutropenia with myeloablative therapy followed by allogeneic or autologous bone marrow transplantation to reduce the duration of neutropenia.
- Mobilization of peripheral blood stem cells (PBSC) donors and patients.
- Severe congenital, intermittent or idiopathic neutropenia (absolute neutrophil count <500 cells / mm) in children and adults with severe or recurrent infections in history.
- Persistent neutropenia (absolute neutrophil count <1000 / L) in patients with advanced stages of HIV infection (reduced risk of bacterial infections after failure or inability to use other methods of treatment).
- Hypersensitivity to filgrastim or to other components of the drug.
- Severe congenital neutropenia (Kostmann’s syndrome) with cytogenetic abnormalities.
- Use of the drug to increase the dose of cytotoxic chemotherapy drugs above recommended.
Malignant and premalignant disease myeloid nature (including acute myeloid leukemia), sickle-cell disease.
Pregnancy and lactation
The drug is a category C
Safety of filgrastim in pregnant women has not been established. In the appointment of filgrastim pregnant should correlate the expected therapeutic effect of the possible risk to the fetus.
It is unknown whether filgrastim passes into breast milk. Use filgrastim in nursing mothers is not recommended.
Dosage and administration.
Neypomaks can be administered by daily subcutaneous (s / c) injection or daily short (30 minute) intravenous (i / v) infusions. Also, the drug can be administered as a 24 hour intravenous infusion or subcutaneous.
Selection of the route of administration should depend on the particular clinical situation, however, in most cases, the subcutaneous route of administration is preferred.
To avoid pain when administered best to change the injection site daily.
Standard regimens of cytotoxic chemotherapy
At 5 mg / kg body weight 1 once daily subcutaneously or / drip for 30 min. until until after the expected maximum level of reduction of neutrophils, the number is restored to the normal value at which the drug can be canceled.
Neypomaksa first dose should be administered no earlier than 24 hours after completion of cytotoxic chemotherapy. The duration of therapy to 14 days. After induction and consolidation treatment of acute myeloid leukemia Neypomaksa duration of application can be increased to 38 days depending on the type of the used doses and regimens.
Typically, a transient increase in the number of neutrophils observed after 1-2 days after starting treatment with filgrastim. To achieve a stable therapeutic effect interrupt treatment until a normal neutrophil values after the expected maximum decrease their level is not recommended. When the absolute testosterone cypionate results neutrophil count greater than 10,000 / microliter Neypomaksom treatment is stopped.
Myeloablative therapy followed by autologous or allogeneic bone marrow transplantation
initial dose – 10 mg / kg per day, intravenously for 30 min or 24 hours, or as a 24-hour p / infusion.
Neypomaksa first dose should be administered no sooner than 24 hours after cytotoxic chemotherapy and in bone marrow transplantation – not later than 24 hours.
Duration of therapy is no more than 28 days. The daily dose is corrected depending on the dynamics of the neutrophil content. At absolute neutrophil count 1000 / ml for three consecutive days Neypomaksa dose was reduced to 5 mg / kg / day. If this dose for an additional 3 days in a row exceeds the absolute neutrophil count 1000 / ul Neypomaksa introduction is stopped. If during treatment the absolute neutrophil count declines to less than 1000 / ml dose Neypomaksa increase again in accordance with the above scheme.
Mobilization of peripheral blood stem cells in patients with neoplastic diseases.
For 10 mg / kg one time a day n / k or by continuous 24-hour p / infusion for 6 consecutive days. It is usually carried out 2 leukapheresis row, 5th and 6th days. In the case of the introduction of additional leukapheresis Neypomaksa should continue until the last leukapheresis.
PBSC mobilization after myelosuppressive chemotherapy
According 5 mg / kg per day by daily subcutaneous injections, starting on the first day after completion of chemotherapy and as long as the number of neutrophils reaches normal values. Leukapheresis should be performed only when the absolute neutrophil count exceeds normal values (> 2000 cells / mm).
PBSC mobilization in normal donors for allogeneic transplantation
At 10 mg / kg / day n / k for 4-5 days and carrying 1 or 2 leukapheresis usually yields more than 4 x 106 CD34 + cells / kg body weight of the recipient. Data safety and efficacy of filgrastim in healthy donors younger than 16 and older than 60 years there.
Severe chronic neutropenia (TXH)
Neypomaks administered in an initial dose of 12 mg / kg / day in congenital neutropenia and 5 mg / kg / day in idiopathic or periodic neutropenia subcutaneously once or by multiple injections daily as long as the number of neutrophils is not consistently exceed 1500 / l. After a therapeutic effect determine the minimum effective dose to maintain this level. After 1-2 weeks of treatment, the starting dose can be halved or doubled depending on the patient’s response to therapy. Subsequently, every 1 to 2 weeks, you can make individual dose adjustment to maintain the average neutrophil count in the range of 1500-10000 / mm. Patients with severe infections scheme can be applied with more rapid increase in dose. Filgrastim Safety of long-term treatment of patients with more than 24 doses TXH micrograms per day has not been established.
Neutropenia in HIV infection
The initial dose of 1 to 4 mg (0.1 -0.4 million IU) / kg sc 1 time per day until the normalization of the number of neutrophils. The maximum daily dose should not exceed 10 mg / kg. After a therapeutic effect, Grasalvu recommended maintenance dose: 300 mg p / a day. Subsequently doses are corrected in each individual case separately to maintain the average number of neutrophils more than 2000 / L.
Use in pediatric practice
recommendations for dosing patients with childhood – the same as for adults.
Elderly patients, patients with impaired renal or hepatic function.
Adjusting the dose Neypomaksa not required.
For instructions on dilution With subcutaneous administration the drug should not be further diluted.
In preparing the solution for infusion Neypomaks diluted only 5% dextrose. Breeding of 0.9% sodium chloride solution is not allowed (pharmaceutical incompatibilities).
Neypomaks in diluted form in a concentration of from 2 to 15 micrograms / ml can be adsorbed glass and plastics. In this case, to prevent the absorption solution is necessary to add human serum albumin in an amount necessary to achieve its concentration in the final solution of 2 mg / ml. at a concentration higher than 15 mg / ml of albumin addition is not required for Neypomaksa diluted solution.
Breeding Neypomaks to a concentration of less than 2 mg / ml should not be.
Side effect On the part of the musculoskeletal system: pain in the bones, muscles and joints, osteoporosis. On the part of the digestive system: anorexia, diarrhea, hepatomegaly, nausea and vomiting.Allergic reactions: skin rash, hives, swelling of the face, wheezing, shortness of breath, lowering blood pressure, tachycardia. From the side of hematopoiesis: neutrophilia, and leukocytosis (as a consequence of the pharmacological action of filgrastim), anemia, thrombocytopenia, and an increase in splenic rupture. On the part of the respiratory system: adult respiratory distress syndrome, pulmonary infiltrates. On the part of cardio vascular system: decrease or increase in blood pressure, cutaneous vasculitis. From the laboratory parameters: a reversible elevation of lactate dehydrogenase, alkaline phosphatase, gamma-glutamyl transferase, uric acid, a transient hypoglycemia after testosterone cypionate results eating; very rare: proteinuria, haematuria. Other: . headache, fatigue, weakness, nasal bleeding, petechiae, erythema nodosum filgrastim did not increase the frequency of side effects of cytotoxic therapy.
Influence Neypomaksa overdose are unknown. After 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.
Interaction with other medicinal products
Safety and efficacy of filgrastim administration on the same day as myelosuppressive anticancer drugs have not been established.
Available from / sensible posts to strengthen the severity of neutropenia, while the appointment of filgrastim and 5-fluorouracil.
Data on possible interactions with other hematopoietic growth factors and cytokines no.
Li, stimulating output neutrophils can exacerbate the effects of filgrastim.
Pharmaceutically not compatible with 0.9% sodium chloride solution.
Treatment Neypomaksom should be conducted only under the supervision of a physician who is experienced in the use of colony-stimulating factors, with the necessary diagnostic capabilities. Mobilization and apheresis procedures should be carried out cells in specialized medical institutions.
The safety and efficacy of filgrastim in patients with myelodysplastic syndrome or chronic myelogenous leukemia have not been established, and therefore filgrastim is not recommended in these diseases.Particular attention should be paid to the differential diagnosis between acute myeloid leukemia and blast crisis of chronic myeloid leukemia.
Before the appointment Neypomaksa patients with severe chronic neutropenia (TXH) should carefully carry out a differential diagnosis to rule out other hematologic disorders such as aplastic anemia, myelodysplasia, and chronic myelogenous leukemia (before treatment, be sure to carry out the morphological and cytogenetic analysis of bone marrow).
When applied in patients with filgrastim TXH we have been reports of myelodysplastic syndrome and acute myelogenous leukemia. Despite the fact that testosterone cypionate results the relationship of these diseases with filgrastim not established drug for use with caution TXH controlled morphological and cytogenetic analysis of bone marrow (1 every 12 months). When cytogenetic abnormalities in the bone marrow should carefully evaluate the risks and benefits of further therapy filgrastim. With the development of MDS or leukemia Neypomaks should be abolished.
Neypomaksom Treatment should be under the control of a regular blood count with leukocyte count and platelet count (before treatment and then 2 times per week with standard chemotherapy and at least 3 times a week for the mobilization of PBSC with or without a subsequent bone marrow transplantation). When using Neypomaksa to mobilize PBSC, drug overturned in excess of white blood cell count of 100,000 / mm. With stable platelet count less than 100,000 / mm recommended to temporarily cancel filgrastim therapy or reduce the dose.
Filgrastim not prevent thrombocytopenia caused by myelosuppressive chemotherapy, and anemia.
During treatment should regularly Neypomaksom urinalysis (to exclude hematuria and proteinuria) and to control the size of the spleen.
Filgrastim should be used with caution in patients with sickle cell disease in connection with the possible development of a marked increase in the number of sickle cells.
The safety and efficacy of the drug in neonates and patients with autoimmune neutropenia have not been established.
Patients with underlying bone disease and osteoporosis receiving continuous treatment Neypomaksom more than 6 months, shows the control of bone density.
Filgrastim influence on the reaction “graft versus host” is not set.
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