Preparation "Leicostim": instructions for use, reviews, analogues

What is the drug Leicostim? Instructions, form of release, indications and contraindications for taking this medication will be described below. Also we will tell you about what analogues are available for this tool, what is included in its composition and so on.

Form, package, composition of medicament

What form does Leukostim have? Instructions for use inform that this medication is available as a solution for subcutaneous and intravenous administration.

The active component of this agent is filgrastim. It is a granulocyte recombinant colony-stimulating factor. 1 ml of the drug solution may contain 300 μg (30 million IU), 600 μg (60 million IU) or 150 μg (15 million IU) of filgrastim.

As for the auxiliary substances, they are mannitol, sodium acetate trihydrate, dextran, acetic acid, polysorbate and water for injections.

What kind of packaging is sold to Leicostim? Instructions for use are enclosed in a cardboard box along with one or five bottles of the drug.

Properties of the medicinal product

What is the mechanism of action of the drug Leicostimulation? Instructions for use, reviews of doctors say that this drug-immunomodulator. It is a non-glycosylated highly purified protein that has a regulatory effect on the production and movement (from bone marrow to blood) of functional neutrophils.

After the administration of the drug significantly increases the number of neutrophils in the blood and slightly - monocytes. This happens for 24 hours.

The increase in neutrophils in the blood is dose-dependent. The production of biologically active protein, ie filgrastim, which normalizes the proliferation and differentiation of cells, is carried out by strains of the bacterium Escherichia coli. By the way, the latter, thanks to the possibilities of modern genetic engineering, is supplemented with the human colony-stimulating granulocyte factor gene.

By its principle of action on the body, this preparation is similar to colony-stimulating granulocyte factor, which has a natural origin. The only differences are the facts that Leicostim (solution) is not glycosylated, and also has the N-terminal amino acid residue of methionine.

Features of the drug

What features does the drug have to Leicosti? The instruction for use states that it is advisable to use it in the diagnosis of neutropenia in people who undergo chemotherapy. Also, this medication is very effective in chronic neutropenia. This is due to the fact that he is able to restore the optimal number of neutrophils in the human body.

Using the drug for prevention, the patient can significantly reduce the incidence of neutropenia, as well as reduce the complexity of the course and the duration of the disease period. Such an impact prevents the occurrence of infectious complications, shortens the duration of hospitalization of the patient, allows for chemotherapy, without deviating from the time limits set by the general treatment regimen.

How does the human body act on Leicostim? The instructions for use indicate that the use of this drug promotes the direction of peripheral blood cells preceding hematopoiesis that are collected by cytapheresis (i.e., blood separation into cellular components with their selective removal) and administered to the patient after a course of high-dosage chemotherapy.

In turn, the introduced cells (stem cells), having a hematopoietic function, restore immunity and hematopoiesis system, and also reduce the risk of occurrence and severity of the course of infectious and hemorrhagic complications.

Drug Safety

Is the drug Leicostim safe for a person? The instruction says that this medication can be used both for children and adults. It is equally safe for all people taking a course of cytotoxic chemotherapy.

For patients with the immunodeficiency virus, the solution provides an optimal level of neutrophils and allows all recommended dosages of antiretroviral or myelosuppressive therapy to be followed.

When using this drug, HIV replication was not observed.

Pharmacokinetics

What pharmacokinetic parameters does the "Leicostim" medication have? The instruction indicates that the concentration of the active component of this agent directly depends on the administered dose.

After subcutaneous administration, the greatest amount of the drug in the blood is observed after about 8-15 hours.

The half-life of the active substance Leucimac is three to four hours. Filgrastim is metabolized to peptides. About 1% of the active ingredient is excreted unchanged together with the urine.

The accumulation of filgrastim in the human body does not occur even with prolonged use of the drug (when the course of therapy exceeds a month). In this case, the half-life period remains the same.

Indications for use

The medicine "Leicosti" is assigned for the following purposes:

• To reduce the duration of the course of neutropenia 2-4 stages, as well as to reduce the frequency of febrile neutropenia in people with non-myeloproliferative neoplasms after chemotherapy with the use of cytostatic agents;
• To reduce the manifestations of complications that occur with neutropenia, as well as to shorten the course of the disease in people undergoing myeloablative chemotherapy with the need for bone marrow transplantation;
• For directing cells preceding hematopoiesis into the peripheral blood for the purpose of transplanting and separating them after myelosuppressive chemotherapy;
• For the treatment of neutropenia in people with HIV infection (including in an extended stage) in order to reduce the risk of infectious diseases of bacterial origin;
• For the treatment of chronic neutropenia;
• For directing cells preceding hematopoiesis to peripheral blood in healthy donors in order to transplant and separate them by patients.

Contraindications for use

What contraindications does the preparation have to Leicostim? The experts' comments report the following prohibitions:

• Increased individual sensitivity of the patient to active and other components of the drug;
• Congenital neutropenia, occurring in severe form with cytogenetic disorders (Costman's syndrome);
• The period of newborns (especially the first month of life).

The drug Leicostim: instruction and application

The medicament in question can be administered in two ways:

• intravenously;
• Subcutaneously.

The dosage, as well as the way of Leukostim administration, should be determined by specialists, depending on the clinical situation, individual characteristics of the patient and the course of the disease. However, it should be noted that it is the subcutaneous administration of the drug that is preferred for medical practice.

When given intravenously, this medication is taken from the vial by means of a syringe, and then it is added to a 5% dextrose bottle. The resulting solution is administered to the patient for half an hour.

How should I apply Leichestkam? The instruction (analogues of this medicine will be considered below) states that this drug should be used no earlier than a day after the end of chemotherapy.

Medicinal solution is prescribed depending on the weight of the patient. Its dosage varies between 5-12 μg per kg of body weight. Injections are performed every day at a frequency of once a day.

The drug should be treated with the drug until the amount of neutrophils in the blood reaches the normal level. Usually the duration of treatment is two weeks.

During the introduction of the drug specialists are required to regularly determine the number of leukocytes in the blood. If their number exceeds 50 000 / mkl, then the medicine is canceled.

During therapy, the patient may develop thrombocytopenia. If the number of platelets is kept below the value of 100,000 / μl during repeated analyzes, the question of temporary withdrawal of the drug or reduction of its dosage is considered.

Side effects

According to statistics, the drug Leicostim quite rarely causes side reactions. However, it can still contribute to the appearance of such effects as:

• Dysuric phenomena;
• Pain in the bones or muscles;
• Alopecia;
• Hepatomegaly, splenomegaly;
• Arterial hypotension (transient);
• Increased levels of uric acid and alkaline phosphatase;
• Weakness, headaches and fatigue;
• Allergic reactions at the beginning of treatment, which are most often manifested after intravenous administration of the drug.

It should also be noted that if the patient is injected incorrectly, unpleasant sensations at the injection site may be disturbing.

Drug Interactions

Before using this drug, it is necessary to find out how Leicostim interacts with other medications. Instruction (INN of this medication sounds like "Filgrastim") contains on this account exhaustive information:

• The drug "5-fluorouracil" increases neutropenia.
• In view of the fact that growing myeloid cells are extremely sensitive to cytotoxic drugs, "Leucostimulation" should be prescribed one day before or after the use of these drugs.
• The drug in question is incompatible with sodium chloride.
• When using the solution to direct the progenitor cells after chemotherapy, it should be borne in mind that mobilization efficiency decreases with long-term use of "Carmustine", "Melphalan" and "Carboplatin."

Special Recommendations

It is highly discouraged to prescribe people with impaired liver and kidney function to Leicostimulation, since the safety and efficacy of filgrastim in this category of patients have not been studied.

Patients with osteoporosis and other bone pathologies who use the drug continuously for six months should monitor bone tissue density.

The effectiveness of the drug in people with a small number of myeloid progenitor cells has not been studied. However, experts argue that in such patients, the degree of increase in the number of neutrophils can be significantly lower.

The efficacy and safety of the use of Leukostima in people with chronic myelogenous leukemia and myelodysplastic syndrome have not been established. In this regard, with such diseases, it is not shown.

Monotherapy with the drug in question does not prevent anemia and thrombocytopenia, which are caused by myelosuppressive chemotherapy. It is required to regularly determine the number of hematocrit and platelets. Particular caution should be exercised when using combined or single-component chemotherapeutic regimens known to be capable of causing severe thrombocytopenia.

Before the start of treatment, "Leucostim" needs to make an extensive blood test with the determination of the number of platelets and the leukocyte formula, as well as to study the karyotype and bone marrow picture.

During the period of therapy, urine samples should be routinely monitored and the size of the spleen monitored.

The drug Leicostim: analogues and price

The following medicines are the analogues of the drug under consideration: "Filerim", "Grazalva", "Granogen", "Neupogen", "Leucite", "Neimomax", "Myelastra", "Neurostim".

As for the price, at "Lejkostim" it is very high. Buy this drug in pharmacies in Moscow, as well as other Russian cities can be for 2500-4500 rubles. The price of this medication depends on the volume and number of ampoules in the package.

Reviews about the drug

Unfortunately, there are very few reviews of patients who take this medication. According to what is available, this medication is especially often prescribed for the immune, as well as for cyclic neutropenia in children. The effect of the drug in such severe diseases is short-lived.

It should also be noted that there are patient reviews of the clinical application of Leucimac in children and adults with neutropenia associated with chemotherapy of tumors. The drug administered to babies at a dosage of 5 μg / kg per day is tolerated fairly well.

Some patients are interested in the question of which of the solutions is better: "Leicostimulation" or "Neupogen." As a result of the clinical studies that were carried out to determine the tolerability and efficacy of these agents, the following conclusions were drawn: the timing of neutropenia elimination after the use of these medications does not differ. Moreover, they have quite the same indicators of efficiency and portability.