Universal reference book for medicines
Name of the drug: NEIPOMAX ® (NEUPOMAX)

Active substance: filgrastim

Type: Leukopoiesis stimulant

Manufacturer: FARMSTANDART-UfaVITA (Russia)
Composition, form of production and packaging
Solution for iv and s / c of administration
in the form of a transparent or slightly opalescent, colorless or slightly colored liquid.

1 f.

filgrastim 30 million AD (300 μg)

Excipients: acetic acid ice, sodium hydroxide, sorbitol, polysorbate 80, water d / u.

1 ml - bottles of glass (5) - contours made of polyvinyl chloride (1) - packs of cardboard.

Solution for iv and s / c of administration in the form of a transparent or slightly opalescent, colorless or slightly colored liquid.

1 ml of 1 fl.

filgrastim 30 million ED (300 μg) 48 million ED (480 μg)

Excipients: acetic acid ice, sodium hydroxide, sorbitol, polysorbate 80, water d / u.

1.6 ml - bottles of glass (5) - packaging out of PVC (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Filgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF).
Has biological activity similar to endogenous human G-CSF, differing from the latter in that it is a non-glycosylated protein with an additional N-terminal methionine residue.
Filgrastim, obtained by recombinant DNA technology, is isolated from the cells of the bacterium Escherichia coli, whose genetic apparatus incorporates the gene encoding the G-CSF protein.

Filgrastim stimulates the formation of functionally active neutrophils, their release into the peripheral blood from the bone marrow and is used in the treatment of patients with neutropenia of various origins.

PHARMACOKINETICS

Suction

Both with / in, and with n / to the administration of filgrastim there is a positive linear dependence of its serum concentration on the dose.

Distribution

V d is about 150 ml / kg.

Excretion

The mean T 1/2 of filgrastim of serum is about 3.5 hours, the clearance is approximately 0.6 ml / min / kg.
Continuous infusion of filgrastim for a period of up to 28 days to patients after autologous bone marrow transplantation is not accompanied by signs of cumulation and an increase in T 1/2 .
INDICATIONS

- reduction of neutropenia and febrile neutropenia due to myelosuppressive cytotoxic chemotherapy of malignant diseases (with the exception of chronic myelogenous leukemia and myelodysplastic syndrome);

- Neutropenia with myeloablative therapy followed by allogeneic or autologous bone marrow transplantation to reduce the duration of neutropenia;

- Mobilization of peripheral blood stem cells (PSSCs) in donors and patients;

- severe congenital, periodic or idiopathic neutropenia (absolute number of neutrophils ≤ 500 / μl) in children and adults with severe or recurrent infections in the anamnesis;

- persistent neutropenia (absolute number of neutrophils ≤ 1000 / μl) in patients with developed stage of HIV infection to reduce the risk of bacterial infections if ineffective or impossible to use other methods of treatment.

DOSING MODE

Neuromax ® can be administered by daily injections or daily short 30-minute IV infusions.
Also, the drug can be administered in the form of IV or S / 24-hour infusions. The choice of route of administration should depend on the specific clinical situation, but in most cases it is preferable that the drug is administered spontaneously.
To avoid pain during injection, the injection site should be changed daily.

Standard schemes of cytotoxic chemotherapy

The drug should be prescribed at 5 μg / kg 1 time / day daily w / w or / in drip for 30 minutes until after the expected maximum reduction in the level of neutrophils their number will not recover to normal.
When the norm is reached, the drug can be canceled.
The first dose of Neuromax should be administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy.
The duration of therapy is no more than 14 days.
After induction and consolidation therapy for acute myelogenous leukemia, the duration of Neupomax use may increase up to 38 days, depending on the type, dosage and chemotherapy used.

Transient increase in the number of neutrophils is observed, as a rule, 1-2 days after the initiation of treatment with filgrastim.
To achieve a stable therapeutic effect, it is not recommended to interrupt treatment until normal neutrophil values ​​are reached after the expected maximum decrease in their level. With an absolute amount of neutrophils> 10 000 / μL, treatment with Neuromax is stopped.
Myeloablative therapy followed by autologous or allogeneic bone marrow transplantation

The initial dose of the drug is 10 μg / kg / day IV drip for 30 minutes or 24 hours, or by 24-hour infusion.
The first dose of Neuromax should be administered no earlier than 24 hours after cytotoxic chemotherapy, and for bone marrow transplantation - no later than 24 hours. The duration of therapy is no more than 28 days.
The daily dose of the drug is corrected depending on the dynamics of the neutrophil content.
If the absolute number of neutrophils exceeds 1000 / μL for 3 consecutive days, the dose of Neuromax is reduced to 5 μg / kg / day if the absolute number of neutrophils continues to exceed 1000 / μl for the next 3 days, Neupomax should be discontinued. If during the treatment the absolute amount of neutrophils decreases to less than 1000 / μl, the dose of Neupomax should be increased again, in accordance with the above scheme.
Mobilization of peripheral blood stem cells in patients with neoplastic diseases

The drug should be applied at 10 μg / kg 1 time / day or by continuous 24-hour infusion for 6 consecutive days.
In this case, usually 2 leukapheresis is performed in a row, on the 5th and 6th days. In the case of additional leukapheresis, the administration of Neupomax should be continued until the last leukapheresis is carried out.
Mobilization of PSKC after myelosuppressive chemotherapy

The drug should be applied at 5 μg / kg per day by daily injections, starting from the first day after completion of chemotherapy and until the number of neutrophils reaches normal values.
Leukapheresis should be performed only when the absolute number of neutrophils exceeds the normal value (> 2000 / μl).
Mobilization of PSKC in healthy donors for allogeneic transplantation

The use of the drug at 10 μg / kg / day for 4-5 days and 1-2 leukapheresis usually yield CD34 + > 4 × 10 6 cells / kg body weight of the recipient.

Severe chronic neutropenia (THC)

Neuromax ® should be used at an initial dose of 12 mcg / kg / day for congenital neutropenia and 5 mcg / kg / day for idiopathic or intermittent neutropenia sc, once or by several administrations daily until the neutrophil count is stably greater than 1500 / / RTI & gt;
Once the therapeutic effect is achieved, the minimum effective dose is determined to maintain this level. After 1-2 weeks of treatment, the initial dose can be doubled or reduced by half, depending on the patient's response to therapy.
Subsequently, every 1-2 weeks, individual dose adjustments can be made to maintain the average number of neutrophils in the range of 1500-10 000 / μL.
In patients with severe infections, a scheme with a faster increase in dose can be used. The safety of filgrastim with long-term treatment of patients with TCN doses exceeding 24 μg / kg / day has not been established.
Neutropenia in HIV infection

The initial dose of the drug is 1-4 μg (0.1-0.4 million units) / kg p / k 1 time / day until the normalization of the number of neutrophils.
The maximum daily dose should not exceed 10 mcg / kg.
After achieving a therapeutic effect, it is recommended to use Neupomax ® in a maintenance dose of 300 μg p / c every other day.
The further dosage regimen is corrected in each individual case separately to maintain the average number of neutrophils> 2000 / μL.
Recommendations on the dosage regimen for children correspond to those for adults.
Data on the safety and efficacy of filgrastim in healthy donors under the age of 16 are not available.
Patients with impaired renal and / or liver function , as well as elderly patients, are not required to adjust the dosage regimen of Neuromax.
Data on the safety and efficacy of filgrastim in healthy donors over the age of 60 years are not available.
Rules for the preparation of solutions

With n / to the introduction of the drug should not be diluted further.
When preparing the solution for infusion as a solvent, it is recommended to use only 5% dextrose solution. Dilution 0.9% solution of sodium chloride is not allowed because of pharmaceutical incompatibility.
Neupomax ® diluted in a concentration of 2 to 15 μg / ml can be adsorbed by glass and plastic materials.
In this case, to prevent absorption in the solution of the drug, add human serum albumin in the required amount to reach its concentration in the final solution of 2 mg / ml. For a diluted solution of Neupomax at a concentration of more than 15 μg / ml, the addition of albumin is not required. Do not dilute Neupomax ® to a concentration of less than 2 μg / ml.
SIDE EFFECT

From the musculoskeletal system: pain in the bones, muscles and joints, osteoporosis.

On the part of the digestive system: anorexia, diarrhea, hepatomegaly, nausea, vomiting.

On the part of the hematopoiesis system: neutrophilia, leukocytosis (as a consequence of the pharmacological action of filgrastim), anemia, thrombocytopenia, enlargement and rupture of the spleen.

On the part of the respiratory system: adult respiratory distress syndrome, infiltrates in the lungs.

From the cardiovascular system: a decrease or increase in blood pressure, cutaneous vasculitis, tachycardia.

On the part of laboratory indicators: reversible increase in LDH, alkaline phosphatase, GGT, uric acid, transient hypoglycemia after ingestion;
very rarely - proteinuria, hematuria.
Allergic reactions: skin rash, hives, face swelling, wheezing, shortness of breath.

Other : headache, fatigue, general weakness, epistaxis, petechiae, erythema nodosum.

Filgrastim does not increase the incidence of adverse reactions of cytotoxic therapy.

CONTRAINDICATIONS

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

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

- Hypersensitivity to filgrastimu or other components of the drug.

With caution should be used in case of malignant and premalignant diseases of myeloid nature (including acute myelogenous leukemia), sickle cell anemia.

PREGNANCY AND LACTATION

The drug of category C. The safety of filgrastim in pregnancy is not established, therefore, when prescribing the drug, pregnant women should correlate the estimated benefit to the mother and the potential risk to the fetus.

It is not known whether filgrastim is excreted in breast milk.
Use filgrastim during breastfeeding is not recommended.
APPLICATION FOR CHILDREN

Recommendations on the dosage regimen for children correspond to those for adults.

Data on the safety and efficacy of filgrastim in healthy donors under the age of 16 are not available

Safety and effectiveness of the drug in newborns are not established.

SPECIAL INSTRUCTIONS

Neimaxax should be treated only under the supervision of a physician with experience in the use of CSF and with the necessary diagnostic capabilities.
Procedures for mobilization and apheresis of cells should be carried out in specialized medical institutions.
The safety and efficacy of filgrastim in patients with myelodysplastic syndrome and chronic myelogenous leukemia have not been established, and therefore filgrastim is not recommended for these diseases.
Particular attention should be given to the differential diagnosis between acute myelogenous leukemia and blast crisis of chronic myelogenous leukemia.
Prior to the appointment of Neuromax to the patents with TCN, differential diagnosis should be carefully conducted to exclude other hematologic diseases such as aplastic anemia, myelodysplasia and chronic myelogenous leukemia (before the start of therapy, a morphological and cytogenetic analysis of the bone marrow).

When filgrastim was used in patients with THC, cases of myelodysplastic syndrome and acute myeloblastic leukemia were noted.
Despite the fact that the relationship of the occurrence of these diseases with filgrastim is not established, the drug should be used with TCN with caution under the control of the morphological and cytogenetic analysis of the bone marrow (1 every 12 months). When cytogenetic abnormalities appear in the bone marrow, the risk-benefit ratio should be carefully assessed for further therapy with filgrastim. With the development of myelodysplastic syndrome or leukemia, Neuromax should be discontinued.
Treatment with Neuromax should be carried out under regular control of a general blood test, counting the leukocyte count and the number of platelets (before the start of therapy and then twice a week with standard chemotherapy and at least 3 times a week in mobilizing PSKK with or without a subsequent bone marrow transplantation).
When Neimaxax is used to mobilize PSKK, the drug is canceled if the number of leukocytes exceeds 1x10 5 / μl. With a stable amount of platelets not exceeding 1x10 5 / μl, it is recommended to temporarily cancel filgrastim therapy or reduce the dose of the drug.
Filgrastim does not prevent thrombocytopenia caused by myelosuppressive chemotherapy and anemia.
During treatment with Neipomax, urine analysis should be done regularly (to exclude hematuria and proteinuria) and control the size of the spleen.
Filgrastim should be used with caution in patients with sickle-cell anemia due to the possible substantial increase in the number of sickle cells.

The safety and efficacy of the drug in patients with autoimmune neutropenia have not been established.

Patients with bone pathology and osteoporosis receiving continuous treatment with Neuromax more than 6 months require control of bone density.

The effect of filgrastim on the "graft versus host" reaction has not been established.

Use in Pediatrics

Recommendations on the dosage regimen for children correspond to those for adults.

Data on the safety and efficacy of filgrastim in healthy donors under the age of 16 are not available.

Safety and effectiveness of the drug in newborns are not established.

OVERDOSE

The effects of Neupomax overdose are unknown.

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.

DRUG INTERACTION

The safety and efficacy of filgrastim administration on the same day as myelosuppressive antitumor drugs have not been established.

There are some reports of increased neutropenia with the simultaneous administration of filgrastim and 5-fluorouracil.
Data on the possible interaction with other hematopoietic growth factors and cytokines are currently not available.
Lithium, stimulating the release of neutrophils, can enhance the action of filgrastim.

Pharmaceutical interaction

Dilution 0.9% solution of sodium chloride is not allowed because of pharmaceutical incompatibility.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of the reach of children, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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