A large

To date, medicine and pharmacology is not able to offer mankind a cure for cancer. But to stop the process and return the patient to life, prolonging it for an indefinite time, it is capable. Widely used in this perspective is a cytotoxic drug like Navelik, thanks to which more than one human life has already been saved.

[1]

Indications A large

The drug under consideration is characterized by a rather specific and narrowly directed spectrum of action. Indications for use Navelik:

• Fine-dispersed malignant lesion of lung tissue ( lung cancer ).
• Malignant neoplasms of the breast, complicated by metastasis.

[2], [3], [4], [5]

Release form

The drug is available only in the form of solutions for intravenous injection, which are characterized by a fairly slow administration of the drug. The concentration of the drug is 10 mg / ml. Form release differs only in the capacity of the bottle: 1 ml or 5 ml.

The resulting solution is a liquid of light yellow or transparent color, which is not allowed to be mixed with other pharmacological preparations.

In one milliliter of the drug is 13.85 mg of active ingredient vinorelbine tartrate (this amount is equivalent to 10 mg vinorelbine). In the role of an additional chemical compound, pure water for injection is used.

Pharmacodynamics

This drug is referred to a group of antitumor drugs that, when exposed to cancer cells, cause their necrosis. And also to antineoplastic drugs of the form of vinca alkaloids (Vinca). This is what determines the pharmacodynamics of Navelik. This medicine acts on the patient's body at the molecular level. In this case, there is an effect on the ratio of the dynamic nature between microtubules and turbulence. The drug effectively slows or completely stops (inhibits) the process of polymerization of tubulin.

Preferably, the active substance of the drug acts on mitotic microtubules. The effect of the overlap on the turbulence in the spiral is not very pronounced. But the effect of the drug on axonal microtubules is fixed only at a sufficiently high concentration of vinorelbine.

The drug effectively blocks the indirect division of cells in the G2 / M periods of the cell cycle, which leads the pathologically changed cell to death. This occurs either during interphase (the period after cell division, when its nucleus "rests"), as well as during the next division (mitosis).

[6], [7], [8], [9], [10], [11]

Pharmacokinetics

The drug is administered only intravenously! After getting into the blood system of the patient, vinorelbine is very quickly spread through the tissues. Pharmacokinetics The blood flow has three phases. The clearance of creatinine from the plasma is quite significant - approximately from 0.8 to 1 l / h per kilogram. The half-life (T _½ ) of the drug and its metabolites (at the peak terminal phase) averages forty hours. The percentage of the compound of the Heavy on the protein component of the plasma, depending on the clinical state of the patient, varies between 50 and 80%. The active substance is excreted from the body of the patient together with bile.

[12], [13], [14], [15], [16], [17]

Dosing and administration

In the instructions attached to the drug, it is clearly stipulated that the drug Navelik is injected into the patient's body only intravenously! The way of application and dose vary slightly depending on the protocol of treatment chosen by the doctor for the management of the disease.

In the case of monotherapy with Nalewixom, the starting one-off amount of the drug is prescribed - 25-30 mg per square meter of the patient's surface (mg / m ² ). The drug is administered to the patient once a week.

If the treatment protocol is presented as a complex therapy, the drug concentrate is diluted with 0.02-0.05 l sodium chloride solution (0.9%) or with a solution of 5% glucose. In this case, the received volume of the drug is administered slowly, for six to ten minutes. At the end of the procedure, the vein of the patient must be washed very well with 0.9% sodium chloride solution.

If the patient suffers also on the pathology of the liver, the dosage of the drug should be reduced.

In the case of using cytotoxic drug, it is necessary to take special measures of safety.

1. Before using the drug, the medical manipulation sister must visually examine the drug. The solution should be a light yellow or transparent shade without additional microinclusions.
2. During the introduction of the drug, the syringe needle must be in the vein. Even a slight ingress of the solution into other tissues or onto the epithelium can provoke the development of cellulite or necrotic wounds.
3. If extravasation does occur, the drug should be discontinued and the drug should be aspirated as soon as possible. Local injection of 1 ml of hyaluronidase 250 IU / ml is performed. The solution is administered subcutaneously next to the lesion. Also apply relatively hot applications, which reduce the concentration of Navelik in the subcutaneous space, which reduces the likelihood of development of pathological consequences.
4. The remaining solution is gently inserted into the vein of the other arm.
5. If the product gets into the eyes, they should be rinsed very quickly under running water.
6. If Navelk fell on the skin, this place should be washed immediately under running water, then rinsed with soap and again under running water.
7. Preparation of the solution is carried out in a specialized room with highly qualified personnel, which is dressed in special uniforms: a robe with long sleeves, a cap on the head, a protective mask and glasses, disposable covers and gloves is mandatory.
8. It is very cautious to behave with waste, obtained during the dilution of the drug, as well as with the excreta and vomit masses of the patient.
9. Not allowed to work with cytotoxic drugs, which is Navelik, medical workers who bear the child (gestation period).
10. If the container is damaged, all precautions necessary for handling hazardous substances must be taken.
11. Waste of cytotoxic drugs should be disposed of by burning in labeled special rigid containers.

There are also features of using Navelik.

1. When the drug is administered, the condition and the blood formula must be constantly monitored. Such an analysis is done before each introduction.
2. If the next performed analysis showed agranulocytosis (a decrease in all blood counts (<2000 / mm ³ ): low hemoglobin, leukocyte and platelet levels and so on), then the drug administration should be suspended until the hematological parameters normalize.
3. In the case of diagnosing liver failure in patients, the dosage of Navelik is reduced.
4. Since clinical studies of the effects of Navelki on patients with kidney dysfunction and / or heart disease associated with insufficient blood supply have not been carried out, it should be used with caution. These patients should be under the constant supervision of a doctor - an oncologist.
5. The joint administration of the drug in question and radiotherapy, which is directed to the liver region, is strictly prohibited.

[33]

Use A large during pregnancy

The period when a woman waits for a child is very careful in using any medication. And in connection with the peculiarities of the pharmacodynamics of the drug, the use of Navelik during pregnancy is categorically contraindicated. If there is a need for therapy with Navelik, during the treatment, the feeding of the newborn with breast milk must be stopped.

Information on the results of treatment and harmlessness of the medicinal product for the child's organism at this time is not available.

Contraindications

Any pharmacological preparation is a complex of chemical compounds capable of affecting the human body, both in a positive and negative field. Contraindications to use

• Period of gestation.
• Time of feeding a newborn baby with breast milk.
• Severe degree of liver dysfunction.
• Joint application of Navilik and phenytoin.
• Complex administration with live attenuating vaccines.
• Combinations with the yellow fever vaccine.
• Joint injection of Navigluc with itraconazole.

[18], [19], [20], [21], [22], [23], [24], [25], [26], [27]

Side effects A large

Due to the pharmacological orientation of the drug, taking the drug may cause undesirable side effects.

• Peripheral nervous system can work:
  • Reduction of the stereotyped reaction of the tendons to the stimulus.
  • Rarely, but there may be signs of paresthesia-the numbness of the limbs.
  • In the case of prolonged therapy, there may be increased muscular fatigue of the lower extremities.
• The cardiovascular system reacts quite seldom (it is possible to count only a few recorded cases), but it can still manifest itself:
  • Myocardial infarction.
  • Transient changes in the parameters of the electrocardiogram (ECG).
  • The appearance of chest pains (stenocardia).
• The organs of the respiratory system are able to react:
  • Bronchial spasm.
  • A short rest.

This symptomatology may appear both immediately after the administration of the drug, and after a few hours - it all depends on the characteristics of the patient's body and the severity of the pathology.

• The circulatory system can provoke:
  • Agranulocytosis is a pathological condition in which partial or complete disappearance of neutrophils from the peripheral blood is observed.
  • Granulocyte thrombocytopenia - a reduced content of granulocytes in peripheral blood.
  • Anemia.
• Gastrointestinal tract is able to react:
  • Nausea.
  • Relatively rare, but intense intoxication can provoke vomiting.
  • Intestinal paresis - a decrease in its functional activity.
  • Constipation.
  • Very rarely, in exceptional cases, one can observe paralytic intestinal obstruction.
• In isolated cases, alopecia can be manifested - pathological hair loss.
• Pain in the jaw area.
• During the injection of Navelk at the injection site, a skin reaction, up to tissue necrosis, may occur.

[28], [29], [30], [31], [32]

Overdose

With the drug, you need to be careful enough. When you receive an increased dose of medication, you get an overdose of it and the patient's body is able to react with pathological symptoms. It can be:

• Agranulocytosis.
• Sharply increases the risk of repeated damage to the human body by infection of various genesis, with incompleteness of treatment for another primary infection (superinfection). Such a turn of the therapeutic picture of the disease may pose a threat to the life of the patient.

Severe form of granulocyte thrombocytopenia.

[34]

Interactions with other drugs

The drug in question behaves in many ways, like all cytotoxic drugs. Since it is used in the treatment of cancer, it is necessary to study the interaction between Navelik and other drugs with special attention. Since in the process of therapy the probability of thrombosis increases, the doctor - the oncologist necessarily appoints the patient anticoagulants. Given the high individual profile of the peak coagulability of blood in the case of cancer pathology, and also based on the potential for increased interaction of antitumor drugs with oral anticoagulants, it is necessary to constantly monitor their percentage in the patient's blood and periodically check the level of coagulation.

Categorically contraindicated joint use of the drug Navelik and phenytoin. Such a tandem can cause convulsions in the body, as there is a decrease in the level of absorption of phenytoin in the mucosa of the digestive tract. The same reaction can be expected from the patient's body in the case of Navelik's interaction with such drugs as doxorubicin, cisplatin, bleomycin, daunorubicin, vincristine, carboplatin, methotrexate, vinblastine and carmustine.
When the drug under consideration interacts with the vaccine used to treat yellow fever, a secondary generalized infection can be obtained that can lead to a lethal outcome.

It is not necessary to appoint live attenuated vaccines together with antitumor drugs. This combination increases the risk of fatal damage to the patient with a generalized disease. Especially this probability increases against the background of antitumor therapy in case of a decrease in the body's defenses. In this situation, other activated vaccines should be used (for example, against poliomyelitis).

With extreme caution use a combination of Navelik and cyclosporine (similarly with etoposide, tacrolimus and doxorubicin). Such a combination can especially affect the decrease in immunity, which entails the development of lymphoproliferation.
As a result, the neurotoxicity of itraconazole increases - this reaction appears due to a decrease in the activity of metabolism in the liver. The same reaction is provided by the combined use of the drug and mitomycin C.

[35], [36], [37], [38]

Storage conditions

All medicines must be stored in a place that is inaccessible to children. Also, the storage conditions of Navelik are quite severe to the climatic regime. The temperature in the room where the preparation is located must comply with the requirement - from +2 ° C to +8 ° C. It is necessary to avoid direct sunlight and freeze the drug.

[39], [40]

Shelf life

Concentrate solution for infusions Navelik has a shelf life of two years. After this period, the use of the drug is strictly prohibited. The physico-chemical stability of the drug after its dilution in a 0.9% solution of sodium chloride or 5% glucose is observed throughout the day (24 hours). This time it can be stored at room temperature, in a darkened room. After this, the solution should not be used. Microbiological stability allows immediate, after breeding, use.

[41], [42]