Zarcio

Zarzio has a broad spectrum of use. It is often used to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients who have received cytotoxic chemotherapy.

Indications Zarcio

Indications for the use of Zarzio mainly consist of the use of the drug during chemotherapy for malignant neoplasms. The exception in this case are myeloleukemia and myelodysplastic syndromes.

The drug is also used to reduce the duration of neutropenia in patients who have received myeloablative therapy with subsequent bone marrow transplantation. The drug is also used to mobilize peripheral stem cells and during myelosuppressive therapy.

It is widely used in hereditary periodic or idiopathic neutropenia in children and adults. Moreover, if the absolute number of neutrophils is 0.5 × 10 ⁹ /l or less.

Long-term drug treatment is also indicated when the number of neutrophils increases to reduce the frequency and duration of adverse effects. Especially if all this is associated with infectious complications.

The drug is also used as a preventive measure against bacterial infections and treatment of persistent neutropenia. Especially in those patients who have advanced HIV infection, if other treatments do not provide the necessary effect. Zarzio has a wide range of applications.

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Release form

The drug is available in a solution for intravenous and subcutaneous administration. The product is colorless or has a slight yellowish tint. It is usually transparent, but may change its appearance somewhat. Minor deviations are considered normal.

One syringe contains 500 ml of the drug. The main active ingredient is filgrastim. Excipients are glutamic acid, sorbitol, polysorbate, water and sodium hydroxide.

The drug is sold in blisters, which are placed in card packs. One syringe contains 0.5 ml of the active substance. The glass of the "vessel" is colorless, which allows you to verify the amount of contents and see its external data.

The product is produced exclusively in the form of a solution. No other "packaging" exists. This medicine has a wide range of uses. Therefore, it is more effective to use it in the form of a solution, which is administered intravenously or subcutaneously. Zarzio is a good remedy in the fight against the adverse effects of chemotherapy.

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Pharmacodynamics

Pharmacodynamics of the drug - the active substance is filgrastim. It is a highly purified non-glycosylated protein that consists of 175 amino acids. The component is produced by the K12 strain of Escherichia coli.

The human granulocyte colony-stimulating factor (G-CSF) gene is introduced into its genome by means of genetic engineering. It is capable of regulating the production and release of neutrophils from the bone marrow into the peripheral blood. The use of this active substance can be accompanied by a significant increase in the number of neutrophils in the vascular bed within 24 hours.

In some cases, an increase in the number of eosinophils and basophils is possible. However, this phenomenon may be present before the start of treatment with this medication. The increase in the number of neutrophils is dose-dependent. The released neutrophils have increased or normal functional activity. This has been confirmed more than once based on tests. After the drug therapy is discontinued, the number of neutrophils decreases by 50% in a couple of days. This indicator returns to normal within a week.

Patients taking filgrastim experience a reduction in the incidence and duration of neutropenia and febrile neutropenia. This allows them to use antibiotics in moderate doses. In addition, the need for prolonged hospitalization is reduced. The incidence of fever did not decrease after myeloablative therapy.

The use of the drug in monotherapy can mobilize the release of hematopoietic stem cells into the peripheral bloodstream. The use of PBSCs that were mobilized with Zarzio can accelerate the restoration of hematopoiesis. In addition, a decrease in the severity and duration of thrombocytopenia is observed. It is possible to reduce the risk of hemorrhagic complications and the need for platelet transfusion after myeloablative or myelosuppressive therapy.

The use of the drug in children and adults with severe congenital neutropenia can stimulate a stable increase in the number of active neutrophils in the peripheral blood. A decrease in the frequency of infectious and other complications is also observed. The use of the drug Zarzio allows maintaining the number of neutrophils within acceptable limits.

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Pharmacokinetics

Pharmacokinetics of the drug - distribution occurs in the systemic bloodstream. Increased concentration of the active substance in the blood plasma with intravenous and subcutaneous administration is achieved within 8-16 hours.

A direct linear relationship was also noted between the administered dose of filgrastim and its concentration in the blood plasma. It is pointless to talk about exact figures in this case. Much depends on the previously prescribed dosage.

As for the process of elimination, it does not have a special linear dependence. The speed of this phenomenon depends on the dosage of the drug. Basically, the drug is eliminated with the participation of neutrophils. The speed of elimination with repeated administration of the drug increases as long as the number of neutrophils increases.

Long-term use of Zarzio, which was 28 days, was not accompanied by accumulation. Even in those patients who had undergone bone marrow transplantation. In addition, it had acceptable T _{1/2 values.}

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Dosing and administration

The method of application and dosage of Zarzio depends on the person's condition. Therapy with the drug is carried out in cooperation with doctors of the oncology center. Only those people who have experience with it can use this drug. Therefore, you cannot take the drug on your own.

In cytotoxic chemotherapy, the daily dose of the drug should not exceed 0.5 million U/kg of body weight. The first time the drug is administered no earlier than 24 hours after chemotherapy. It is used until (daily) the number of neutrophils returns to normal. The duration of treatment does not exceed 14 days. In extremely difficult cases, it is increased to 38 days. An increase in neutrophils is usually observed on the second day after the start of using the drug. Patients who receive myeloablative therapy begin taking the drug with 1 million U/kg of body weight. The first dose is administered 24 hours after chemotherapy and no later than the specified time after bone marrow transplantation. Dose adjustments are made on an individual basis. The drug is administered over 30 minutes.

When mobilizing peripheral blood stem cells, 1 million U/kg of body weight should be used. The drug is used for 5-7 days. In some cases, an additional leukapheresis session is required. The recommended dose of the drug is 0.5 million U/kg. Starting from the first day of taking the drug and ending with the last, until the neutrophil level reaches an acceptable value. It can be administered as a long-term infusion for 24 hours.

In severe chronic neutropenia of congenital nature, it is worth taking 1.2 million U/kg. This is done once or in divided doses. In idiopathic or periodic neutropenia, it is necessary to use 0.5 million U/kg. After 1-2 weeks, the dose can be increased.

HIV infection. The recommended initial dose is 0.1 million IU/kg. Subsequently, it can be increased to 0.4 million IU/kg. In rare cases, it reaches 1 million IU/kg. As a maintenance effect, 0.3 mg/day should be taken 2-3 times a week. Over time, the dose of Zarzio can be adjusted.

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Use Zarcio during pregnancy

The use of Zarzio during pregnancy is limited. No specific data regarding the use of this drug have been obtained. However, despite this, there are indications that filgrastim may cross the placental barrier.

Animal studies have been conducted in which filgrastim was not associated with teratogenic effects. A large number of miscarriages have been reported, but no fetal abnormalities have been observed.

If pregnant women need to use the medicine, they need to realistically evaluate the benefit-risk criterion. After all, the expected therapeutic effect for the mother may not always have a positive effect on the development of the baby.

There is no data on the penetration of the drug into breast milk. Therefore, if there is a need to use the drug during breastfeeding, then the latter activity should be stopped. In any case, you can find an alternative way to solve this problem. In many cases, it is recommended to stop using Zarzio.

Contraindications

There are contraindications to the use of Zarzio, even more so, there are quite a lot of them. First of all, it is worth excluding the use of the drug by people suffering from hereditary fructose intolerance. Because the drug contains sorbitol.

If a person has severe hereditary neutropenia accompanied by cytogenetic abnormalities, the drug should not be used. The drug should not be used to increase doses of cytotoxic chemotherapeutic drugs that exceed the norm.

When using radiation or chemotherapy together with cytotoxic. The stage of chronic renal failure is also prohibited. The drug should not be used in newborns under any circumstances. Naturally, people with increased sensitivity to the drug or its main components are at risk.

The drug should be used with caution in myelodysplastic syndrome, chronic myeloid leukemia and secondary acute myeloblastic leukemia. There is also a particular risk in people with a significantly reduced number of myeloid precursor cells. In any case, Zarzio can only be used after consulting a doctor.

Side effects Zarcio

Side effects of Zarzio are related to the high content of the active component. From the immune system side, anaphylactic reactions, urticaria, skin rash, angioedema, decreased blood pressure and shortness of breath may occur.

The blood-forming organs can also react negatively to taking the medicine. Thus, this manifests itself in the form of anemia and transient thrombocytopenia. Thrombocytopenia and splenomegaly can be observed quite often. In extremely rare cases, the spleen ruptures.

From the nervous system, headaches may occur. The cardiovascular system may also react negatively. In this case, there is a decrease in blood pressure, vascular disorders and, in extremely rare cases, veno-occlusive disease.

Respiratory system: nosebleed, rarely pulmonary edema, pulmonary infiltrates and hemoptysis. Dyspnea, pulmonary hemorrhage and hypoxemia are possible.

On the part of the skin and its appendages, this is often vasculitis and rash. In rare cases, febrile dermatosis. Musculoskeletal system: quite often manifests itself in the form of pain syndrome in the joints and muscles. Serious consequences are also possible, such as osteoporosis and exacerbation of rheumatoid arthritis.

The digestive system often manifests itself in the form of diarrhea and hepatomegaly. From the laboratory parameters, a reversible increase in the activity of alkaline phosphatase and LDH cannot be ruled out. In some cases, Zarzio causes severe fatigue and direct reactions at the injection sites.

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Overdose

Overdose of Zarzio medication has not been observed. The fact is that it is used only under the supervision of a doctor. Therefore, a person cannot independently influence the administration of this medication. Based on this, there were no cases of overdose.

Naturally, this point should not be ruled out. After all, situations can be different. Thus, an incorrectly calculated dose can lead to a high concentration of the drug in the human blood plasma. This can negatively affect the patient's well-being.

This indicates that you cannot take the drug on your own. The dose directly depends on the person's condition and illness. The drug has a wide range of action and is used in many cases. Therefore, dose adjustment is individual.

If you follow the basic rules for taking the drug and do not exceed the permissible dose, then there can be no overdose. Zarzio is a powerful drug that should be used with caution, because it is much easier to cause harm than to eliminate its consequences.

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Interactions with other drugs

Interactions with other drugs are possible, but this should be done under the supervision of a doctor. Thus, the safety and effectiveness of administering the drug on the same day as chemotherapy have not been established.

Rapidly dividing myeloid cells are very sensitive to myelosuppressive cytotoxic chemotherapy, so it is not recommended to administer Zarzio within 24 hours of or after their use. The severity of neutropenia may be increased by concomitant administration of the drug with fluorouracil.

The interaction of the drug with other hematopoietic growth factors and cytokines cannot be ruled out. It is necessary to take into account the fact that lithium stimulates the release of neutrophils. All this can enhance the effect of the drug Zarzio. Such an effect is possible with a complex prescription of the drug. No studies have been conducted regarding this.

There is a high risk of incompatibility of the drug with 0.9% sodium chloride solution. Therefore, it is not recommended to use Zarzio in this case.

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Storage conditions

Storage conditions of Zarzio play a big role. But, due to the fact that the medicine is used exclusively in medical institutions, there is no need to worry about this at home.

But, despite this, it is worth following certain rules. The storage temperature of the product should not exceed 25 degrees, this is the generally accepted norm. Zarzio cannot be stored in the refrigerator and especially not frozen.

You also need to monitor humidity, it plays a significant role in the entire storage process. It is advisable to allocate a dry place for the medicine, where direct sunlight will not penetrate.

In a medical institution, children will not be able to get into the drug, but at home, they can. Therefore, it is necessary to protect access to the drug. After all, its use by children is unacceptable in most cases and requires a certain dosage.

You should also pay attention to the appearance of the drug. The solution should not change its color or smell. If this happens, then most likely certain storage conditions for Zarzio were not observed.

Shelf life

The expiration date is important, but only if the storage conditions are properly observed. It is important to create a certain temperature regime. It is desirable that it does not exceed the permissible 25 degrees. Deviation from the norm is possible, but not significant.

Humidity also plays a big role, because it can negatively affect the main qualities of the medicine. After opening the "bottle", you need to use the product immediately. You cannot store the solution in an open form. Put it in the refrigerator or freeze it, especially. This is not the medicine that should be stored in such conditions. It is advisable to protect it from direct sunlight, which is an important criterion.

Pay attention to the appearance of the product. The color and smell should not differ from the norm. Otherwise, you cannot take the medicine. Storage conditions play a big role, because the shelf life, which is 2-3 years, depends on them. After the specified time, it is not recommended to use Zarzio.

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