NEYPOMAKS

Active material: Filgrastim
When ATH: L03AA02
CCF: Stimulator leykopoeza
ICD-10 codes (testimony): D70
When CSF: 19.01.01.01
Manufacturer: OAO Pharmstandard-UfaVITA (Russia)

DOSAGE FORM, COMPOSITION AND PACKAGING

The solution for I / O and p / to the introduction in the form of transparent or slightly opalesciruûŝej, colorless or slightly colored liquid.

Excipients: glacial acetic acid, Sodium hydroxide, sorbitol, polysorbate 80, water d / and.

1 ml – glass bottles (5) – package outline of PVC (1) – packs cardboard.

The solution for I / O and p / to the introduction in the form of transparent or slightly opalesciruûŝej, colorless or slightly colored liquid.

Excipients: glacial acetic acid, Sodium hydroxide, sorbitol, polysorbate 80, water d / and.

1.6 ml – glass bottles (5) – package outline of PVC (1) – packs cardboard.

Pharmacological action

Filgrastim – recombinant human granulocyte colony-stimulating factor (G-CSF). Has biological activity, similar endogenous human g-CSF, Unlike the last order, What is neglikozilirovannym protein with the added N-end balance of methionine.

Filgrastim, obtained by recombinant DNA technology, separated from cells of the bacterium Escherichia coli, a part of the genetic apparatus which introduced gene, g-CSF protein.

Filgrastim stimulates the formation of functionally active neutrophils, their output in peripheral blood from the bone marrow and is used in the treatment of patients with neitropenia different origin.

Pharmacokinetics

Absorption

As with the/in, and when s/to the introduction of Filgrastim there is a positive linear dependence of its serum concentration of dose.

Distribution

V_d is approximately 150 ml / kg.

Deduction

The average value of T_1/2 Filgrastim from whey is about 3.5 hours, the ground is approximately 0.6 ml / min / kg. Continuous infusion of Filgrastim for period up to 28 days patients after autologous bone marrow transplantation is not accompanied by signs of cumulation and increase T_1/2.

Testimony

-reducing the period of neutropenia and the frequency of febrile neutropenia caused by mielosupressivnoj cytotoxic chemotherapy of malignant diseases (with the exception of chronic myeloid leukemia and mielodisplastičeskogo syndrome);

-neutropenia with mieloablativnoj therapy with subsequent autologous transplantation or Allogenic bone marrow transplantation to reduce the duration of neutropenia;

-mobilization of peripheral blood stem cells (TUAC) donors and patients;

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

-resistant neutropenia (absolute neutrophil count ≥ 1000/µl) in patients with HIV infection to reduce the risk of bacterial infections with inefficiency or inability to use other treatments.

Dosage regimen

Nejpomaks^® You can enter daily p/injection or daily short 30-minute on/in infusions. Also, medication can be entered as in/in or n/a 24-hour infusions. The choice of the route of Administration must depend on the specific clinical situation, However, in most cases, preferably n/a a drug.

To avoid pain when injected should change daily injections.

Standard schemes cytotoxic chemotherapy

The agent should be appointed on the 5 mg / kg 1 times/d daily p/or to the in/in drip for 30 min until, until after the expected maximum reduction level of neutrophils, their number will not be restored to normal indicator. When you reach the standards of a drug can be cancelled.

The first dose of Nejpomaksa^® should be no earlier than, than 24 hours after completion of the course, cytotoxic chemotherapy. Duration of therapy is not more 14 days.

After induction and consolidation therapy of acute myeloid leukemia duration of Nejpomaksa^® may increase to 38 days depending on the type of, doses used chemotherapy schemes.

Transient increase in the number of neutrophils is observed, usually, through 1-2 days after start of treatment filgrastimom. In order to achieve stable therapeutic effect it is not recommended to interrupt treatment before reaching normal values of neutrophils following the anticipated maximum reduction level. In absolute number of neutrophils >10 000/MCL Nejpomaksom treatment^® stop.

Mieloablatius therapy with subsequent autologous or allogeneic bone marrow transplantation

The initial dose of the drug is 10 mcg/kg/day, in/in drip for 30 min or 24 no, or by 24-hour p/infusion. The first dose of Nejpomaksa^® should be no earlier than, than 24 hours after the holding of cytotoxic chemotherapy, and when bone marrow transplantation – not later than, than 24 no. Duration of therapy is not more 28 days.

Daily dose of the drug korrigiruetsâ depending on the dynamics of the content of neutrophils. If the absolute number of neutrophils within 3 consecutive days exceeds 1000/µl, dose Nejpomaksa^® reduced to 5 ug / kg / day, If, in applying this dose for the next 3 days of the absolute number of neutrophils has continued to exceed the value of 1000/µl, Introduction Nejpomaksa^® discontinue. If during the treatment, the absolute number of neutrophils decreases to less than 1000/µl, dose Nejpomaksa^® should increase again, in accordance with the above schema.

Mobilization of peripheral blood stem cells in patients with tumor Diseases

The preparation should be applied to 10 mg / kg 1 times/day p/or enter through the continuous 24-hour p/infusions over 6 days in a row. While usually spend 2 MSC in a row, on the 5-th and 6-th days. In case of additional MSC introduction Nejpomaksa^® should continue until the last MSC.

TUAC mobilization after mielosupressivnoj chemotherapy

The preparation should be applied to 5 μg/kg per day by daily p/injection, starting from the first day after chemotherapy completion and until, While the number of neutrophils reaches normal values. Lejkaferez should be carried out only if, When the absolute number of neutrophils to exceed normal value (>2000/l).

TUAC mobilization in healthy donors for allogeneic transplantation

Application on 10 mcg/kg/day p/within 4-5 days and conduct 1-2 lejkaferezov usually yields CD34⁺>4x10⁶ cells/kg body weight of the recipient.

Severe chronic neutropenia (PIU)

Nejpomaks^® should be used in the initial dose of 12 mcg/kg/day with congenital neutropenia and 5 mcg/kg/day with idiopathic or periodic neutropenia p/to one or multiple daily injections by so far, While the number of neutrophils is steadily exceed 1500/MKL. After therapeutic effect defines the minimum effective dose to maintain this level of. Through 1-2 the initial weeks of treatment dose can be doubled or halved, Depending on the patient's response to therapy.

Subsequently every 1-2 weeks you can produce individual correction doses to maintain the average number of neutrophils in the range 1500-10 000/l. In patients with severe infections, you can apply a scheme with a more rapid increase in dose. Safety of Filgrastim in the long-term treatment of patients with doses more THN 24 mcg/kg/day is not installed.

Neutropenia in HIV infection

Initial dose 1-4 g (0.1-0.4 million. ED)/kg n/a 1 times/day to normalize the number of neutrophils. The maximum daily dose should not exceed 10 mg / kg.

After therapeutic effect, recommended Nejpomaks^® the maintenance dose – by 300 µg p/a day. Further dosage korrigiruetsâ in each individual case in order to maintain the average number of neutrophils >2000/l.

Recommendations for dosing regime for children correspond to those for adults. Data on the safety and effectiveness of Filgrastim in healthy Donor younger 16 years no.

Patients with violations of the kidney and/or liver, and elderly patients correction mode Nejpomaksa^® not required. Data on the safety and effectiveness of Filgrastim in healthy donors older than 60 years no.

Terms preparing solutions

When s/to the introduction of the drug further breeding should not be. When cooking solution for infusion as a solvent, it is recommended to use only 5% Dextrose. Breeding 0.9% solution of sodium chloride is not allowed because the pharmaceutical incompatibility.

Nejpomaks^® in the form of razvedennom at concentrations of 2 to 15 µg/ml can be adsorbed glass and plastic materials. In this case, to prevent absorption of the drug solution, you must add the human serum albumin in necessary quantity to achieve concentrations in the final solution 2 mg / ml. For the diluted solution Nejpomaksa^® at a concentration of more than 15 ug/mL adding albumin does not require. You should not breed Nejpomaks^® concentration to less than 2 ug / ml.

Side effect

On the part of the musculoskeletal system: ostealgias, muscles and joints, osteoporosis.

From the digestive system: anorexia, diarrhea, gepatomegaliya, nausea, vomiting.

From the hematopoietic system: neutrophilia, leukocytosis (as a consequence of the pharmacological action of Filgrastim), anemia, thrombocytopenia, increase and spleen.

The respiratory system: respiratory distress syndrome, adult, pulmonary infiltrates.

Cardio-vascular system: decrease or increase in blood pressure, kozhnыy vasculitis, tachycardia.

From the laboratory parameters: reversible increase of LDH, Alkaline phosphatase, GGT, Uric acid, passing hypoglycemia after eating; rarely – proteinuria, hematuria.

Allergic reactions: skin rash, hives, swelling of the face, wheezing, breathlessness.

Other: headache, fatigue, generalized weakness, nose bleed, petechiae, uzlovataya эritema.

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

Contraindications

-severe congenital neutropenia (Kostmann syndrome) with cytogenetic disorders;

-use of the drug with the aim of increasing doses of cytotoxic chemotherapeutic drugs, exceeding the recommended dose;

-hypersensitivity to filgrastimu or other components of the drug.

FROM caution the drug should be used in malignant and myeloid diseases, pretumorous nature (incl. acute myeloid leukemia), sickle cell disease.

Pregnancy and lactation

Product category with. Safety of Filgrastim in pregnancy has not been established, Therefore, in appointing the drug to pregnant women should relate the expected benefit to the mother and the potential risk to the fetus.

Unknown, whether allocated Filgrastim in breast milk. Apply Filgrastim during breastfeeding is not recommended.

Cautions

Should be treated Nejpomaksom^® only under the supervision of a physician, with experience of CSF and, subject to the availability of diagnostic possibilities. Procedures for the mobilization and Apheresis cells shall be carried out in specialized medical institutions.

Safety and efficacy of Filgrastim in patients with mielodisplastičeskim syndrome and chronic myelogenous leukemia is not installed, in connection with data than with diseases use not recommended Filgrastim. Particular attention should be paid to the differential diagnosis between acute myelogenous leukemia and chronic myeloid leukemia crisis blastnym.

Before assigning Nejpomaksa^® with paicentam THN should carefully spend the differential diagnosis, to exclude other hematologic diseases, such as aplastic anemia, myelodysplasia and chronic myelogenous leukemia (before starting therapy should conduct morphological and cytogenetic analysis of bone marrow).

When applying Filgrastim in patients with THN were marked by instances of mielodisplastičeskogo syndrome and acute mieloblastnogo leukemia. Despite, the relationship of these diseases with the use of Filgrastim is not installed, apply when THN it should be carefully controlled by morphological and cytogenetic analysis of bone marrow (1 once every 12 months). With the emergence of cytogenetic abnormalities in the bone marrow should carefully weigh the risks and benefits with the further therapy filgrastimom. In developing mielodisplastičeskogo syndrome or leukemia Nejpomaks^® should be abolished.

Treatment Nejpomaksom^® should be under the regular supervision of general analysis of blood leukocyte count and platelet count (before therapy and continue 2 times per week when standard chemotherapy and not less than 3 Once a week in mobilizing TUAC with or without subsequent bone marrow transplant). When applying Nejpomaksa^® to mobilize the TUAC medication overturned, If the white blood cell count is greater than 1 x 10⁵/l. With a stable number of platelets, no greater than 1 x 10⁵/l, We recommend that you temporarily disable filgrastimom therapy or reduce the dose of the drug.

Filgrastim does not prevent mielosupressivnoj caused by chemotherapy and anemia thrombocytopenia. During treatment Nejpomaksom^® You should regularly do a urine test (for the exclusion of hematuria and proteinuria) and control the size of the spleen.

Filgrastim should be used with caution in patients with sickle-cell anemia in connection with the possible substantial increase in the number of sickle cell cells.

Safety and efficacy of the drug in patients with autoimmune neutropenia is not installed.

Patients with bone disease and osteoporosis, receiving continuous treatment Nejpomaksom^® more 6 months, to control bone density.

Effect of Filgrastim reaction “graft-versus-host disease” not installed.

Use in Pediatrics

Recommendations for dosing regime for children correspond to those for adults.

Data on the safety and effectiveness of Filgrastim in healthy Donor younger 16 years no.

The safety and efficacy of the drug in Newborn not set.

Overdose

Effects of overdose Nejpomaksa^® unknown.

Through 1-2 the day after the preparation, the number of circulating neutrophils is usually reduced by 50%, with the return to normal through 1 -7 days.

Drug Interactions

The safety and efficacy of filgrastim administration in the same day, that and mielosupressiveh anticancer agents, not set.

There are anecdotal reports of strengthened neutropenia together with the appointment of Filgrastim and 5-fluorouracil. Data on the possible interaction with other growth factors and cytokines haemopoetic currently no.

Lithium, stimulating neutrophil output, It may exacerbate the effects of Filgrastim.

Pharmaceutical interaction

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

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children, in the dark place at a temperature of no higher than 25° c. Shelf life – 2 year.