What is the drug Leukostim? Instructions, form of release, indications and contraindications for taking this medication will be described below. We will also tell you about what analogues this tool has, what is included in its composition and so on.
Form, packaging, composition of the medication
What form does Leukostim take? Instructions for use informs that this medication is available in the form of a solution for subcutaneous and intravenous administration.
The active component of this tool is filgrastim. It is a granulocyte recombinant colony stimulating factor. In 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 excipients, they use mannitol, sodium acetate trihydrate, dextran, acetic acid, polysorbate and water for injection.
In what packaging is Leukostim solution sold? Instructions for use are enclosed in a cardboard box along with one or five bottles of the drug.
Drug properties
What is the mechanism of action of the Leukostim medication? Instructions for use, reviews of doctors say that this is an immunomodulator drug. 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 administration, the drug significantly increases the number of neutrophils in the blood and slightly - monocytes. This happens within 24 hours.
An increase in neutrophil blood is dose-dependent. The production of a biologically active protein, that is filgrastim, which normalizes the proliferation and differentiation of cells, is carried out through strains of the bacterium Escherichia coli. By the way, the latter, thanks to the capabilities of modern genetic engineering, is supplemented by the colony-stimulating granulocytic factor human gene.
By its principle of exposure to the body, this drug is similar to a colony-stimulating granulocytic factor, which is of natural origin. The only differences are the facts that Leukostim (solution) is not glycosylated and also has an N-terminal amino acid residue of methionine.
Features of the drug
What features does the Leukostim medicine have? The instruction for use states that it is advisable to use it in the diagnosis of neutropenia in people who are undergoing chemotherapy. Also, this medication is very effective in chronic neutropenia. This is due to the fact that it 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. This effect prevents the occurrence of infectious complications, reduces the duration of hospitalization of the patient, allows chemotherapy, without deviating from those terms that were established by the general treatment regimen.
How does Leukostim affect the human body? Instructions for use indicate that the use of this medication facilitates the transfer to the peripheral blood of cells preceding hematopoiesis, which are collected by cytapheresis (i.e. separation of blood into cellular components with their selective removal) and are administered to the patient after a course of high-dose chemotherapy.
In turn, the introduced cells (stem), which have hematopoietic function, restore the immune system and the hematopoietic system, and also reduce the risk of occurrence and severity of the course of infectious and hemorrhagic complications.
Medication safety
Is Leukostim safe for humans? The instruction says that this medication can be used both for children and adults. It is equally safe for all people undergoing cytotoxic chemotherapy.
For patients with immunodeficiency virus, the use of a solution provides an optimal level of neutrophils and makes it possible to follow all the recommended dosages of antiretroviral or myelosuppressive therapy.
When using this drug, HIV replication was not observed.
Pharmacokinetics
What pharmacokinetic parameters does the Leukostim drug have? The instruction indicates that the concentration of the active component of this agent directly depends on the dose administered.
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 "Leukostim" is three to four hours. Filgrastim is metabolized to peptides. About 1% of the active ingredient is excreted unchanged with 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). At the same time, its half-life remains the same.
Indications for use
The medicine “Leukostim” is prescribed for the following purposes:
- to reduce the duration of the course of neutropenia of 2-4 stages, as well as to reduce the incidence of febrile neutropenia in people with non-myeloproliferative neoplasms after chemotherapy with cytostatic agents;
- to reduce the manifestations of complications that occur with neutropenia, as well as to reduce the duration of the disease in people undergoing myelo-ablative chemotherapy with the need for bone marrow transplantation;
- to direct cells preceding hematopoiesis to peripheral blood in order to transplant and separate them after myelosuppressive chemotherapy;
- for the treatment of neutropenia in people with HIV infection (including in the advanced stage) in order to reduce the risk of infectious diseases of bacterial origin;
- for the treatment of chronic neutropenia;
- to direct cells preceding hematopoiesis to peripheral blood in healthy donors in order to transplant and separate them to patients.
Contraindications
What contraindications does Leukostim have? Reviews of experts report the following prohibitions:
- increased individual sensitivity of the patient to active and other components in the composition of the drug;
- congenital neutropenia occurring in severe form with cytogenetic disorders (Costmann syndrome);
- the period of the newborn (especially the first month of life).
The drug "Leukostim": instructions and use
The medication in question can be administered in two ways:
- intravenously;
- subcutaneously.
The dosage, as well as the route of administration of Leukostim, 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 subcutaneous administration of the drug is preferable to medical practice.
With intravenous administration, this medication is taken from the vial using a syringe, and then it is added to the vial with 5% dextrose. The resulting solution is administered to the patient for half an hour.
How should Leukostim be used? The instruction (analogues of this medicine will be discussed below) states that this drug must be used no earlier than a day after the end of chemotherapy.
The drug solution is prescribed depending on the weight of the patient. Its dosage varies between 5-12 mcg per 1 kg of weight. Injections are carried out every day with a frequency of once a day.
Therapy with the drug in question should be carried out until the number of neutrophils in the blood reaches a normal level. Typically, the duration of treatment is two weeks.
During the administration of the drug, specialists are required to regularly determine the number of white blood cells in the blood. If their number exceeds 50,000 / μl, then the medication is canceled.
During therapy, the patient may develop thrombocytopenia. In the event that, during repeated analyzes, the platelet count remains below 100,000 / μl, then the issue of temporarily discontinuing the drug or reducing its dosage is considered.
Side effects
According to statistics, the drug "Leukostim" rarely causes adverse reactions. However, it can still contribute to the appearance of effects such as:
- dysuric phenomena;
- bone or muscle pain;
- allopecia;
- 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 most often occur after intravenous administration of the drug.
It should also be noted that if the patient is injected improperly, discomfort at the injection site may disturb.
Drug interaction
Before using this drug, it is necessary to find out how “Leukostim” interacts with other medicines. The instruction (INN of this medicine sounds like “Filgrastim”) contains comprehensive information on this subject:
- The medication “5-fluorouracil” enhances neutropenia.
- Due to the fact that growing myeloid cells are extremely sensitive to cytostatic agents, “Leukostim” should be prescribed one day before or after using these drugs.
- The medication in question is incompatible with sodium chloride.
- When using a solution to direct progenitor cells after chemotherapy, it should be borne in mind that mobilization efficiency decreases with the long-term use of Karmustin, Melphalan and Carboplatin.
Special recommendations
It is highly recommended that “Leukostim” be prescribed to people with impaired liver and kidney function, since the safety and effectiveness of filgrastim in this category of patients have not been studied.
Patients with osteoporosis and other bone pathologies that use the drug continuously for six months should monitor bone 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 effectiveness and safety of Leukostim in people with chronic myelogenous leukemia and myelodysplastic syndrome have not been established. In this regard, with such diseases, it is not indicated.
Monotherapy with the drug in question does not prevent anemia and thrombocytopenia due to myelosuppressive chemotherapy. It is required to regularly determine the number of hematocrit and platelets. Particular care must be taken when using combined or single-component chemotherapeutic regimens, which are known for their ability to cause severe thrombocytopenia.
Before starting treatment with Leukostim, a detailed blood test should be done to determine the number of platelets and the white blood cell count, as well as to examine the karyotype and picture of the bone marrow.
During therapy, it is required to regularly conduct a urinalysis and monitor the size of the spleen.
The drug "Leukostim": analogues and price
The following drugs are analogues of the drug in question: Filergim, Grazalva, Granogen, Neupogen, Leucitis, Neupomax, Myelastra, Neurostim.
As for the price, then Leukostim has a very high price. You can buy this drug in pharmacies in Moscow, as well as in other cities of Russia for 2500-4500 rubles. The price of this medication depends on the volume and number of ampoules in the package.
Drug Reviews
Unfortunately, there are very few reviews of patients who take this drug. According to what is available, this medication is especially often prescribed for 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 reviews of patients about the clinical use of Leukostim in children and adults with neutropenia associated with tumor chemotherapy. The drug is prescribed for babies at a dosage of 5 mcg / kg per day, it is tolerated quite well.
Some patients are interested in the question of which solution is better: Leukostim or Neupogen. As a result of clinical studies that were carried out in order to identify the tolerability and effectiveness of these drugs, the following conclusions were drawn: the timing of the elimination of neutropenia after using the mentioned medications does not differ. Moreover, they have exactly the same indicators of effectiveness and tolerability.