Neostim - instructions for use, dose, side effects, contraindications

Active substanceMolgrastimMolgrastim

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Neostim®

lyophilizate in / in PC

FDS Pharma United Kingdom

Dosage form: & nbspLiophilizate for the preparation of a solution for intravenous and subcutaneous administration.

Composition:

1 bottle contains:

active substance: molgramostim 150 mcg (1.67 x 10⁶ME);

Excipients: Mannitol, human serum albumin, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate.

Description:

White, loose tablet.

Dissolved drug: colorless, clear liquid.

Pharmacotherapeutic group:leukopoiesis stimulant

ATX: & nbsp

Molgrastim

Pharmacodynamics:

Neostim® is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF, GM-CSF), is a water-soluble, non-glycosylated protein. It consists of 127 amino acids, has a molecular weight of 14,447 daltons. It is formed by a strain Escherichia colicarrying a gene-engineered plasmid containing the granulocyte-macrophage colony-stimulating factor gene.

Natural human GM-CSF is the most important regulatory factor ensuring the growth, maturation and functional activity of many blood cells. GM-CSF has a polyvalent effect on various hematopoiesis: it activates mature myeloid cells, stimulates proliferation and differentiation of progenitor cells of the hematopoietic system,which leads to the formation of granulocytes, monocytes / macrophages and T-lymphocytes, without affecting the growth of B-lymphocytes. The drug significantly increases the leukocyte count in the blood, mainly neutrophils, and, to a lesser extent, lymphocytes and eosinophils.

GM-CSF is able to enhance the expression of Class II antigens of the main histocompatibility complex on human monocytes and to increase the production of antibodies. Additionally, GM-CSF has a significant effect on the functional activity of mature neutrophils, that includes enhancement of phagocytosis of bacteria, increased cytotoxicity against malignant cells and activation of oxidative metabolism in neutrophils - reaction having a great importance for the protective body.

Molgraimost does not stimulate or inhibit the growth of tumor cells.

After a single parenteral administration, the effect of the drug is manifested in 1-4 hours and reaches a peak after 6-18 hours.

Pharmacokinetics:

For subcutaneous (s / c) injection of the drug in doses of 5 to 20 mg / kg by intravenous (i / v) administered the drug in doses of 5 to 25 mcg / kg value area under "concentration-time" curve (AUC) directly depend on the size of the dose.

After s / w introduction, the maximum concentration of molramostim in the serum was achieved after 3-4 hours. The drug is rapidly metabolized. The half-life of mnogramostim after IV introduction was 1-2 hours and after SC administration - 2-3 hours.

Indications:

The preparation is shown:

- patients undergoing myelosuppressive therapy (antitumor chemotherapy), in order to reduce the severity of neutropenia, which reduces the risk of infection and allows full compliance with the chemotherapy regimen;

- patients with insufficient bone marrow hematopoiesis caused by other causes (myelodysplastic syndromes / aplastic anemia), in order to reduce the risk of developing infections resulting from leukopenia;

- patients undergoing autologous or syngeneic bone marrow transplantation, in order to accelerate the recovery of myelogenous hematopoiesis

- patients with leukopenia associated with infectious diseases (including HIV infection), in order to accelerate the recovery of myelogenous hematopoiesis;

- patients with cytomegalovirus retinitis in HIV infection, in addition to ganciclovir,to reduce the severity of ganciclovir-induced neutropenia and the full compliance with the recommended dosage regimen of ganciclovir.

Contraindications:

- Hypersensitivity to molgramostimu or any other component of the drug;

- simultaneous use of extensive radiation therapy (due to an increased risk of developing severe complications from the lungs);

- the drug is not used to increase the intensity of cytotoxic chemotherapy above the doses set in the appropriate regimens;

- thrombocytopenic purpura of an autoimmune genesis in the anamnesis;

- myeloid leukemia;

- pregnancy and the period of breastfeeding.

Dosing and Administration:

Subcutaneous injections or intravenous infusions.

The dosage regimen is set taking into account the indications.

The dose of Neostima® is usually set in micrograms, but in some cases, use International Units (1 μg equals 0.0111 million, ME).

The maximum daily dose is 10 μg / kg body weight (0.11 million IU / kg).

When myelosuppressive therapy. Neostim® is prescribed in a daily dose of 5-10 μg / kg subcutaneously. Treatment begins 24 hours after the end of cytotoxic therapy and continues for 7-10 days.

When myelodysplastic syndromes and aplastic anemia: 3 μg / kg 1 time per day subcutaneously. Usually for the manifestation of the therapeutic effect of the drug (increasing the number of leukocytes in the blood) it takes from 2 to 4 days. Subsequently, the daily dose is selected so that the white blood cell count is maintained at the desired level (usually less than 10,000 / μL).

When bone marrow transplantation. Neostim® is administered iv by drop (within 4-6 hours) at a daily dose of 10 μg / kg. The preparation is started the day after the bone marrow transplantation. Therapy is performed until the absolute neutrophil count is> 1000 / μl. The maximum duration of treatment is 30 days.

When leukopenia caused by infections (including HIV infection) the drug is prescribed in a dose of 1-5 μg / kg 1 time per day subcutaneously. In patients with HIV infection who are treated with zidovudine or a combination of zidovudine and alpha interferon, Neostim® is given at a dose of 1-3 μg / kg subcutaneously. The increase in the number of leukocytes is observed after 2-4 days of treatment. Further, to maintain the desired level of white blood cells (usually less than 10,000 / μL), the daily dose of Neostim® is corrected every 3-5 days.

As an adjunct to the treatment with ganciclovir cytomegalovirus retinitis in HIV infection. Neostim® is administered at a dose of 5 μg / kg 1 time per day subcutaneously. After the introduction of the fifth dose of the drug, its dose is corrected to maintain the number of neutrophils and leukocytes in the blood at a sufficient level (usually ≥ 1000 / μL and <20000 / μL, respectively).

Rules for the preparation of a solution for subcutaneous administration

The Neostyma ® solution should be prepared immediately prior to administration. To prepare a solution for subcutaneous administration in a bottle containing Nostmost®, 1 ml of sterile water for injection should be added and gently mixed until the powder is completely dissolved.

To prepare a solution for intravenous administration, the contents of each of the required number of vials of the lyophilized powder with the appropriate dose of the drug are dissolved in 1 ml of sterile water for injection. The resulting solution of the preparation is further diluted (in pouches or bottles used for intravenous administration) with 0.9% sodium chloride solution or 5% dextrose solution to a final concentration of moligastimum of at least 7 μg / ml. This drug solution is suitable for use for at least 24 hours after preparation (when stored in a refrigerator).

It is not recommended to use infusion systems made of silicone materials, since it is possible to absorb silicone with a silicone gel.

When infusion is recommended to use systems with built-in filters with a low ability to bind proteins and a pore diameter of 0.2 or 0.22 microns.

Side effects:

When listing side effects, the following characteristics of incidence of adverse events are used: very often ≥10%; often ≥1% <10%; infrequently ≥0.1% <1%; rarely ≥0.01% <0.1%; very rarely <0.01%.

From the digestive system: often - nausea, vomiting, anorexia, diarrhea; infrequently - stomatitis, pain in the abdomen.

From the nervous system: often - a feeling of fatigue, asthenia; infrequently - headache, dizziness, paresthesia, confusion; rarely - convulsions, increased intracranial pressure, fainting, cerebral circulation disorders.

On the part of the respiratory system: often shortness of breath; infrequently - bronchospasm, pulmonary edema, pleurisy, pleural effusion; rarely - the occurrence of pulmonary infiltrates; describes several cases of development of respiratory failure or adult respiratory distress syndrome, which can lead to a fatal outcome

From the side of the cardiovascular system: infrequently - arterial hypotension, heart rhythm disturbances, heart failure, pericarditis; rarely - increased capillary permeability, thrombotic / thromboembolic disorders, exudative pericarditis.

From the skin and skin appendages: often - a rash; infrequently - itching, increased sweating.

From the laboratory indicators: the most frequent decrease in the number of platelets, hemoglobin and serum albumin level. There is also an increase in the absolute and relative content of eosinophils in the blood.

Allergic reactions: infrequently - bronchospasm, angioedema, anaphylactic shock.

Local Reactions: pain in the subcutaneous injection site.

Other: often - myalgia, fever, chills; infrequently - nonspecific pain in the chest; rarely - exacerbation or development of autoimmune diseases.

Overdose:

Symptoms: tachycardia, lowering of arterial pressure, dyspnea and influenza-like phenomena.

Treatment: symptomatic under the control of vital functions.

Interaction:

In connection with the fact that the use of molgramostim is associated with a decrease in the concentration of albumin in the blood serum,it may be necessary to change the doses of those drugs that are characterized by a high degree of binding to plasma albumin.

Special instructions:

Neostim® should be administered under the supervision of a physician experienced in the treatment of oncological and hematological diseases or infectious diseases.

The first dose of Neostim® should be administered, ensuring careful medical supervision of the patient.

When allergic reactions occur, neostim® should be immediately discontinued and should not be used in the future.

With the development of pleurisy and / or pericarditis, neostim® should be discontinued.

Neostim® should be administered with caution to neutropenic patients receiving chemotherapy for myeloid malignancies. In such patients, the benefit of reducing neutropenia should be correlated with the theoretical risk of tumor growth associated with cytokine stimulation.

Neostim® should not be given to patients who, after chemotherapy, have more than 5% of myeloblasts in the bone marrow and / or peripheral blood.

In patients with pulmonary diseases, the treatment with a mild aggravation tends to reduce the function of external respiration and the development of dyspnea; such patients require close monitoring.

In the treatment with molgastimom, in some cases development of autoimmune diseases or their aggravation was noted. This should be taken into account when prescribing molgamostim to patients with autoimmune diseases in the anamnesis.

During the treatment with a mnogramostim, blood tests (including the determination of the number of leukocytes, leukocyte formula, platelets, hematocrit) should be performed regularly and the concentration of albumin in the blood serum should be monitored.

It should be borne in mind that the use of chemotherapeutic antitumor drugs in large doses (along with molgrastimom) can increase the risk of thrombocytopenia and anemia.

According to special studies, after the application of a molegalimost, approximately 1% of patients have antibodies to a mildratability. There were no indications for a decrease in the therapeutic activity of the drug in these cases.

The use of Neostim® in elderly patients is carried out in accordance with the usual recommendations.

Form release / dosage:Lyophilizate for the preparation of a solution for intravenous and subcutaneous administration, 150 mcg.

Packaging:

For 150 mcg in bottles of borosilicate glass, sealed with stoppers and coated with a cap aluminum or combined.

For 1 bottle in a blister of PVC film.

For 1 blister with instructions for use in a cardboard bundle.

Storage conditions:At a temperature of 2 to 8 ° C, out of the reach of children.

Shelf life:

30 months.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007095/08

Date of registration:05.09.2008

Expiration Date:Unlimited

The owner of the registration certificate:FDS PharmaFDS Pharma United Kingdom

Manufacturer: & nbsp

Xiamen Amoytop Biotech, Co.ltd. China

Representation: & nbspFDS PharmaFDS PharmaChina

Information update date: & nbsp03.12.2016

Illustrated instructions

Instructions

Neostim® (Neustim®)