Neipomax
Neipomax: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Neupomax
ATX code: L03AA02
Active ingredient: filgrastim (filgrastim)
Manufacturer: Pharmstandard-UfaVITA (Russia)
Description and photo update: 2018-21-11
Prices in pharmacies: from 3850 rubles.
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Neipomax is a leukopoiesis stimulant.
Release form and composition
The dosage form of Neipomax is a solution for intravenous (i / v) and subcutaneous (s / c) administration: transparent or slightly opalescent, colorless or slightly yellowish [1 ml (30 million ME) or 1.6 ml (48 million ME) in glass vials, 5 vials in blisters, 1 package in a cardboard box].
Composition of 1 ml solution:
- active substance: filgrastim - 30 million IU (300 μg);
- additional components: sodium acetate stabilizer trihydrate, polysorbate-80, sorbitol, 1 M acetic acid solution, water for injection.
Pharmacological properties
Pharmacodynamics
Filgrastim, the active substance of Neipomax, is a recombinant human granulocyte colony-stimulating factor (G-CSF) with biological activity similar to endogenous human G-CSF, but unlike it, it is a non-glycosylated protein with an additional N-terminal methionine residue.
Filgrastim is obtained by recombinant DNA technology, isolated from the cells of the bacterium Escherichia coli, in the genetic apparatus of which the gene encoding the G-CSF protein has been introduced.
Neipomax is used for neutropenia of various origins, since it has the ability to stimulate the formation of functionally active neutrophils and their release from the bone marrow into the peripheral blood.
Pharmacokinetics
With intravenous and subcutaneous administration of Neipomax, there is a positive linear dependence of the serum concentration of filgrastim on the dose.
The volume of distribution is about 150 ml / kg. The clearance is about 0.6 ml / min / kg.
The serum half-life is approximately 3.5 hours.
With continuous infusion of Neipomax for a period of up to 28 days, patients who underwent autologous bone marrow transplant did not experience an increase in the half-life and cumulation of the active substance.
Indications for use
According to the instructions, Neipomax is used to treat and prevent neutropenia, the purpose of the drug is:
- shortening the duration of neutropenia with myeloablative therapy followed by autologous or allogeneic bone marrow transplantation;
- reduction in the period of neutropenia and the incidence of febrile neutropenia that developed as a result of myelosuppressive cytotoxic chemotherapy of malignant diseases (with the exception of myelodysplastic syndrome and chronic myeloid leukemia);
- reducing the risk of bacterial infections with persistent neutropenia (absolute neutrophil count ≤ 1000 / μl) in patients with advanced stage of HIV infection (if other treatments are impossible or ineffective);
- treatment of severe congenital, intermittent or idiopathic neutropenia (absolute neutrophil count ≤ 500 / μL) in children and adults with a history of recurrent and severe infections;
- mobilization of peripheral blood stem cells (PSCC) in patients and donors.
Contraindications
Absolute:
- severe congenital neutropenia with cytogenetic disorders (Kostmann syndrome);
- the need to increase the doses of cytotoxic chemotherapeutic drugs above the recommended ones;
- hypersensitivity to any component of Neypomax.
Relative:
- sickle cell anemia;
- malignant and precancerous myeloid diseases (including acute myeloid leukemia).
Instructions for the use of Neypomax: method and dosage
Neipomax is administered subcutaneously as injections or intravenously as short 30-minute infusions. Also, if necessary, it is possible to subcutaneously or intravenously in the form of 24-hour infusions. The choice of the optimal route of administration is made by the physician depending on the specific clinical situation of the patient, but the s / c route of administration of the drug is considered more preferable.
It is recommended to change the injection site every day, this will avoid pain during the injection of the solution.
Rules for the preparation of solutions:
- When administered subcutaneously, Neipomax is not diluted. If an infusion is necessary, a 5% dextrose solution is used as a solvent.
- Due to pharmaceutical incompatibility, it is forbidden to use 0.9% sodium chloride solution for dilution.
- Diluted Neipomax at a concentration of 2–15 μg / ml can be adsorbed to plastic and glass. To prevent absorption, it is necessary to add human serum albumin to the solution; its dose is calculated so that the concentration in the final solution is 2 mg / ml.
- Albumin should not be added to diluted Neipomax at concentrations above 15 μg / ml.
- Do not use Neipomax diluted in concentrations less than 2 μg / ml.
Standard Cytotoxic Chemotherapy Regimens
The recommended dose is 5 mg per kg of body weight 1 time per day s / c or intravenous drip in the form of a short 30-minute infusion.
The first dose is administered no earlier than 24 hours after the end of cytotoxic chemotherapy.
Neipomax is used daily until, after the expected maximum decrease in the level of neutrophils, their number is restored to normal, but no more than 14 days. After reaching the norm, Neipomax is canceled.
The duration of therapy can be increased up to 38 days in patients who received consolidation and induction therapy in connection with acute myeloid leukemia. This takes into account the type of chemotherapy regimen, its type and dose.
A transient increase in neutrophil count is usually noted 1–2 days after starting filgrastim. To achieve a stable therapeutic effect, treatment should not be interrupted until normal neutrophil counts are reached after the expected maximum decrease in their number. In the event that the absolute number of neutrophils exceeds 10,000 / μl, Neipomax is canceled.
Severe chronic neutropenia (THN)
The initial daily dose is: for congenital neutropenia - 12 μg / kg, for idiopathic or intermittent neutropenia - 5 μg / kg. The drug is administered subcutaneously once or for several days until the number of neutrophils is stable above 1500 / μl. After achieving the desired effect for its preservation, Neipomax is used in a maintenance dose, determined individually. After 1–2 weeks of therapy, depending on the patient's response, the initial dose is doubled or halved.
In the future, once every 1–2 weeks, if necessary, an individual dose adjustment is carried out so that it allows maintaining the average number of neutrophils in the range from 1500 / μl to 10,000 / μl.
Patients with severe infections may be treated with a faster dose escalation regimen.
The safety of long-term use of filgrastim in daily doses of more than 24 μg / kg in patients with concurrent CNS has not been established.
Myeloablative therapy followed by autologous or allogeneic bone marrow transplantation
Treatment begins with a daily dose of 10 μg / kg. Neipomax is administered intravenously as a short 30-minute infusion, a 24-hour intravenous or subcutaneous infusion.
The first dose can be administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy, in the case of bone marrow transplantation - no later than 24 hours. The duration of Neypomax application should not exceed 28 days.
Depending on the current number of neutrophils, the daily dose can be adjusted. If for 3 consecutive days the absolute number of neutrophils exceeds 1000 / μl, the daily dose is reduced to 5 μg / kg, when during the next 3 days when using Neipomax in this dose, the absolute number of neutrophils does not fall below 1000 / μl, the drug is canceled. If there is a decrease in the number of neutrophils below 1000 / μl, then the dose is again increased to the initial one.
Mobilization of peripheral blood stem cells (PSCC) in patients with tumor diseases
The recommended dose is 10 mcg / kg once a day s / c as an injection or continuous 24-hour infusion. The drug is used daily for 6 days. In this case, on the fifth and sixth day, leukapheresis is usually performed. If additional or additional leukapheresis is indicated, the administration of Neipomax is continued until the end of the last procedure.
Mobilization of PSCC after myelosuppressive chemotherapy
Neipomax is administered subcutaneously as daily injections.
The recommended daily dose is 5 mcg / kg. The first dose is administered the next day after the end of chemotherapy, treatment is continued until the normal number of neutrophils is reached.
Leukapheresis is possible only after the number of neutrophils exceeds 2000 / μL.
Mobilization of PSCC in healthy donors for allogeneic transplantation
Neipomax is administered subcutaneously.
The recommended daily dose is 10 μg / kg. The duration of treatment is 4–5 days.
One or two leukapheresis usually yields> 4 × 10 6 CD34 + cells / kg of the recipient's body weight.
Neutropenia in HIV infection
The drug is administered s / c. Treatment begins with a daily dose of 1-4 mcg / kg and continues until the neutrophil count is normalized. In some cases, an increase in the daily dose is possible, but not more than up to 10 μg / kg.
After reaching the therapeutic effect, the dose of Neipomax is reduced to a maintenance dose, which is usually 300 mcg every other day.
In the future, the doctor adjusts the dosage regimen individually for each patient so that the dose maintains the average number of neutrophils above 2000 / μl.
Side effects
- from the hematopoietic system: thrombocytopenia, anemia, leukocytosis, neutrophilia, enlargement and rupture of the spleen;
- on the part of the cardiovascular system: cutaneous vasculitis, decrease or increase in blood pressure, tachycardia;
- from the respiratory system: respiratory distress syndrome in adults, infiltrates in the lungs;
- from the digestive system: diarrhea, nausea, vomiting, anorexia, hepatomegaly;
- from the musculoskeletal system: pain in bones, joints and muscles; osteoporosis;
- allergic reactions: skin rash, urticaria, swelling of the face, wheezing, shortness of breath;
- others: epistaxis, general weakness, increased fatigue, headache, erythema nodosum, petechiae;
- on the part of laboratory indicators: transient hypoglycemia after a meal, a reversible increase in the content of alkaline phosphatase, uric acid, lactate dehydrogenase, gamma-glutamyl transpeptidase; very rarely - hematuria, proteinuria.
Filgrastim does not increase the frequency of side effects of cytotoxic drugs.
Overdose
Overdose cases are unknown.
1-2 days after the end of filgrastim therapy, the number of circulating neutrophils usually decreases by 2 times, and after 1-7 days it returns to normal.
special instructions
Treatment with the drug is carried out in specialized medical institutions, under the supervision of a specialist with experience in the use of G-CSF, and subject to the availability of the necessary diagnostic capabilities.
The efficacy and safety of filgrastim use in myelodysplastic syndrome and chronic myeloid leukemia have not been established, therefore, if neutropenia is associated with these diseases, Neipomax is not recommended. Particular attention should be paid to differentiating acute myeloid leukemia from the blast crisis of chronic myeloid leukemia.
Before the appointment of filgrastim, patients with concurrent CNS are shown a thorough differential diagnosis (in particular, morphological and cytogenetic analysis of the bone marrow) in order to exclude the presence of other hematological diseases, such as myelodysplasia, aplastic anemia, chronic myeloid leukemia.
There are isolated cases of acute myeloid leukemia and myelodysplastic syndrome in patients with TCN. The relationship of their development with the use of filgrastim has not been proven, however, it is recommended to use Neipomax with caution in concomitant CNS, including monitoring the morphological and cytogenetic analysis of the bone marrow once a year. If cytogenetic abnormalities are detected in the bone marrow, further treatment with filgrastim is possible only after a careful assessment of the balance of benefits and risks. If myeloid leukemia or myelodysplastic syndrome is confirmed, Neipomax should be canceled.
All patients before the appointment and during the use of filgrastim should be under constant medical supervision, including regular monitoring of the general blood test with the calculation of the leukocyte count and the number of platelets: with standard chemotherapy - 2 times a week, with mobilization of PSKK - at least 3 times a week.
Neipomax, used to mobilize PSKK, should be canceled if the number of leukocytes exceeds 1 × 10 5 / μl. With a stable platelet count of less than 1 × 10 5 / μl, it is recommended to reduce the dose of filgrastim or temporarily stop treatment.
The drug does not prevent thrombocytopenia and anemia caused by myelosuppressive chemotherapy. For this reason, during therapy, it is necessary to control the size of the spleen, to exclude proteinuria and hematuria - to conduct regular urine tests.
In patients with sickle cell disease, the risk of a significant increase in the number of sickle cells is increased during the use of filgrastim, so treatment should be carried out with caution.
Patients with osteoporosis and bone pathologies who receive Neipomax continuously for a period of more than 6 months should monitor their bone density.
The effect of filgrastim on graft versus host reaction has not been established.
The efficacy and safety of the drug in patients with autoimmune neutropenia have not been established.
Application during pregnancy and lactation
The safety of filgrastim when used during pregnancy has not been established, therefore, the drug can only be prescribed if the expected benefit is definitely higher than the potential risks.
The ability of filgrastim to penetrate into breast milk has not been established, therefore, the appointment of Neipomax is not recommended during lactation.
Pediatric use
The dosage regimen for children does not differ from that for adults.
The safety and efficacy of Neipomax in newborns has not been established.
There are no data on the efficacy and safety of filgrastim in healthy donors under the age of 16.
With impaired renal function
No dosage adjustment is required.
For violations of liver function
No dosage adjustment is required.
Use in the elderly
No dosage adjustment is required.
There are no data on the efficacy and safety of filgrastim in healthy donors over the age of 60.
Drug interactions
Filgrastim is pharmaceutically incompatible with 0.9% sodium chloride solution.
Lithium stimulates the release of neutrophils, and therefore can enhance the action of filgrastim.
There are isolated cases of increased neutropenia in patients receiving 5-fluorouracil during the treatment with Neipomax. There are currently no data on drug interactions with other cytokines and hematopoietic growth factors.
The efficacy and safety of filgrastim on the same day with myelosuppressive anticancer drugs has not been established.
Analogs
Analogs of Neipomax are: Granogen, Neupogen, Leucita, Tevagrastim.
Terms and conditions of storage
Shelf life is 2 years.
Store at a temperature not exceeding 25 ° C in a dark place out of the reach of children.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Neypomax
According to reviews of Neipomax, the drug is prescribed not only for neutropenia associated with chemotherapy, but also with a sharp decrease in the number of neutrophils in the blood due to many other diseases that are severe autoimmune and oncological. Also, the use of filgrastim is advisable for HIV infection and viral hepatitis C in patients receiving antiviral therapy for juvenile rheumatoid arthritis.
Regardless of the indication, when using Neipomax, there was a rapid increase in the number of neutrophils and leukocytes, the response to stimulation occurred after about 9 days. However, in patients receiving antiviral drugs, filgrastim should be used for a long time.
There are some complaints about the development of side effects, such as chills, pain in joints and bones, fever, dry mouth, headache.
Thus, Neipomax is used quite often and is highly effective in the treatment and prevention of neutropenia.
The price of Neypomax in pharmacies
The price for Neypomax is on average 4600 rubles. for 5 bottles of 1 ml, 7100 rubles. for 5 vials of 1.6 ml.
Neypomax: prices in online pharmacies
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Drug name Price Pharmacy |
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Neipomax 30 mlnU / ml solution for intravenous and subcutaneous administration 1 ml 5 pcs. 3850 RUB Buy |
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Neipomax 30 mlnU / ml solution for intravenous and subcutaneous administration 1.6 ml 5 pcs. RUB 5,999 Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
