Navelic

Today, medicine and pharmacology are unable to offer humanity a cure for cancer. But it is capable of stopping the process and bringing the patient back to life, prolonging it for an indefinite period of time. Such a cytotoxic drug as Navelik is also widely used in this regard, thanks to which more than one human life has already been saved.

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Indications Navelic

The drug in question has a fairly specific and narrow spectrum of action. Indications for use of Navelik:

• Finely dispersed malignant lesion of lung tissue ( lung cancer ).
• Malignant neoplasms of the mammary gland complicated by metastasis.

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Release form

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

The resulting solution is a light yellow or transparent liquid that cannot be mixed with other pharmacological drugs.

One milliliter of the drug contains 13.85 mg of the active substance vinorelbine tartrate (this amount is equivalent to 10 mg of vinorelbine). Pure water for injection is used as an additional chemical compound.

Pharmacodynamics

The drug in question belongs to the group of antitumor drugs that, when affecting cancer cells, cause their necrosis. And also to antineoplastic drugs of the periwinkle alkaloid type (Vinca). This is what determines the pharmacodynamics of Navelik. This drug affects the patient's body at the molecular level. In this case, there is an effect on the dynamic relationship between microtubules and turbulin. The drug effectively slows down or completely stops (inhibits) the process of tubulin polymerization.

The active substance of the drug mainly affects mitotic microtubules. The effect of Navelik on the process of twisting turbulin into a spiral is expressed insignificantly. But the effect of the drug on axonal microtubules is recorded only at a sufficiently high concentration of vinorelbine.

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

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Pharmacokinetics

The drug is administered intravenously only! After entering the patient's blood system, vinorelbine is very quickly distributed throughout the tissues. The pharmacokinetics of Navelik in the blood has three phases. Creatinine clearance from plasma is quite significant - approximately 0.8 to 1 l / h per kilogram. The half-life (T _½ ) of the drug and its metabolites (in the peak terminal phase) is on average forty hours. The percentage of Navelik compound with the protein component of plasma, depending on the clinical condition of the patient, varies from 50 to 80%. The active substance is excreted from the patient's body together with bile.

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Dosing and administration

The instructions included with the drug clearly state that the drug Navelik is administered to the patient only intravenously! The method of administration and dosage may vary slightly depending on the treatment protocol chosen by the doctor to stop the disease.

In case of monotherapy with Navelix, the initial single dose of the drug is prescribed – 25 – 30 mg per square meter of the patient’s body surface (mg/m2 ⁾. The drug is administered to the patient once a week.

If the treatment protocol is presented by complex therapy, then the concentrate of the drug is diluted with 0.02 - 0.05 l of sodium chloride solution (0.9%) or 5% glucose solution. In this case, the resulting volume of the drug is administered slowly, over six to ten minutes. Upon completion of the procedure, the patient's vein must be very well washed with 0.9% sodium chloride solution.

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

In case of using the cytotoxic drug Navelik, special safety measures must be taken.

1. Before using the drug, the medical handling nurse must visually inspect the medicine. The solution should be light yellow or transparent without additional microinclusions.
2. When the drug is first administered, the syringe needle must be in the vein. Even minor penetration of the solution into other tissues or epithelium can provoke the development of cellulitis or necrotic wounds.
3. If extravasation does occur, the drug administration must be stopped and the drug must be aspirated immediately. Local administration of 1 ml of hyaluronidase 250 IU/ml is performed. The solution is administered subcutaneously near the site of the lesion. Relatively hot applications are also used, which help reduce the concentration of Navelika in the subcutaneous space, which reduces the likelihood of pathological consequences.
4. The remaining solution is carefully injected into a vein in the other arm.
5. If the drug gets into your eyes, rinse them very quickly under running water.
6. If Navelik gets on the skin, the area should be immediately washed under running water, then rinsed with soap, and again under running water.
7. The solution is prepared in a specialized room by highly qualified personnel who are dressed in special uniform: a long-sleeved robe, a cap on the head, a protective mask and glasses, disposable shoe covers and gloves are required.
8. It is necessary to be very careful with waste obtained during the dilution of the drug, as well as with excreta and vomit of the patient.
9. Pregnant medical workers are not allowed to work with cytotoxic drugs, such as Navelik.
10. If the container is damaged, all precautions prescribed for handling hazardous substances must be taken.
11. Waste cytotoxic drugs must be disposed of by incineration in labelled special rigid containers.

There are also some peculiarities in using Navelika.

1. When administering a medicinal product, it is necessary to constantly monitor the condition and formula of the blood. Such analysis is done before each administration.
2. If the next analysis shows agranulocytosis (a decrease in all blood parameters (<2000/mm3 ⁾: low hemoglobin, leukocyte and platelet levels, etc.), then the administration of the drug must be suspended until the hematological parameters are normalized.
3. If patients are diagnosed with liver dysfunction, the dosage of the drug Navelik is reduced.
4. Since clinical studies of the effect of Navelik on patients with renal dysfunction and/or heart disease associated with insufficient blood supply have not been conducted, it should be used with caution. Such patients should be under constant supervision of an oncologist.
5. The combined use of the drug in question and radiation therapy directed at the liver area is strictly prohibited.

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Use Navelic during pregnancy

The period when a woman is expecting a child is characterized by special caution in the use of any medications. And due to the peculiarities of the pharmacodynamics of the drug, the use of Navelik during pregnancy is strictly contraindicated. If there is a need for therapy with Navelik, breastfeeding of the newborn with breast milk should be stopped for the duration of treatment.

There is currently no information on the results of treatment and the safety of the drug for children.

Contraindications

Any pharmacological drug is a complex of chemical compounds capable of affecting the human body, both in a positive and negative field. Contraindications for the use of Navelik:

• The period of gestation.
• Time to breastfeed a newborn.
• Severe liver dysfunction.
• Concomitant use of Navelik and phenytoin.
• Complex administration with live attenuated vaccines.
• Combinations with yellow fever vaccine.
• Co-administration of Navelika with itraconazole.

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Side effects Navelic

Due to the pharmacological focus of the drug, taking the drug may cause unwanted side effects of Navelik.

• The peripheral nervous system is capable of acting:
  • Reduction of the stereotypical reaction of tendons to irritants.
  • Quite rarely, signs of paresthesia – numbness of the limbs – may appear.
  • In case of long-term therapy, increased muscle fatigue of the lower extremities may occur.
• The cardiovascular system reacts quite rarely (only a few recorded cases can be counted), but it can still manifest itself:
  • Myocardial infarction.
  • Transient changes in electrocardiogram (ECG) parameters.
  • The appearance of chest pain (angina pectoris).
• The respiratory system is capable of reacting:
  • Bronchial spasms.
  • Shortness of breath.

Such symptoms may appear either immediately after the administration of the drug or several hours later – 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 there is a partial or complete disappearance of neutrophils from the peripheral blood.
  • Granulocyte thrombocytopenia is a decreased content of granulocytes in the peripheral blood.
  • Anemia.
• The gastrointestinal tract can react:
  • Nausea.
  • Relatively rarely, but intense intoxication of the body can provoke vomiting.
  • Intestinal paresis – a decrease in its functional activity.
  • Constipation.
  • Very rarely, in exceptional cases, paralytic intestinal obstruction can be observed.
• In isolated cases, alopecia – pathological hair loss – may occur.
• Pain in the jaw area.
• During the administration of Navelik, a skin reaction, including tissue necrosis, may occur at the injection site.

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Overdose

You need to be quite careful with the drug Navelix. If you take an increased dose of the drug, you get an overdose and the patient's body can react with pathological symptoms. This may be:

• Agranulocytosis.
• The risk of repeated infection of the human body with various genesis increases sharply, if the treatment of the primary infection is not yet complete (superinfection). Such a turn of the therapeutic picture of the disease can pose a threat to the patient's life.

Severe form of granulocytic thrombocytopenia.

Interactions with other drugs

The drug in question behaves in many ways like all cytotoxic drugs. Since it is used in the treatment of oncological diseases, it is necessary to study the interactions of Navelik with other drugs with special attention. Since the likelihood of thrombosis increases during therapy, the oncologist must prescribe anticoagulants to the patient. Given the high individual profile of amplitude indicators of blood coagulability in the case of cancer pathology, as well as based on the possibilities of increased interaction of antitumor drugs with oral anticoagulants, it is necessary to constantly monitor their percentage ratio in the patient's blood, as well as periodically check the level of coagulability.

The combined use of Navelik and phenytoin is strictly contraindicated. Such a tandem can cause convulsions in the body, since there is a decrease in the level of absorption of phenytoin in the mucous membrane of the digestive tract. The same reaction can be expected from the patient's body in the case of interaction of Navelik with such drugs as: doxorubicin, cisplatin, bleomycin, daunorubicin, vincristine, carboplatin, methotrexate, vinblastine and carmustine.
When interacting with the vaccine used to treat yellow fever, a secondary generalized infection can be obtained, which can lead to a fatal outcome for the patient.

Live attenuated vaccines should not be administered together with antitumor drugs. This combination increases the risk of fatal damage to the patient's body by a generalized disease. This probability especially increases against the background of antitumor therapy in the event of a decrease in the body's defenses. In this situation, other activated vaccines (for example, against poliomyelitis) should be used.

Use the combination of Navelik and cyclosporine (similarly with etoposide, tacrolimus and doxorubicin) with particular caution. Such a combination can have a particularly strong effect on the decrease in immunity, which entails the development of lymphoproliferation.
Navelik provokes an increase in the neurotoxicity of itraconazole - such a reaction occurs due to a decrease in the activity of metabolism in the liver. The same reaction is given by the combined use of the drug in question and mitomycin C.

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Storage conditions

All medicines must be stored in a place inaccessible to children. Also, the storage conditions of Navelik are quite strict to the climate regime. The temperature in the room where the drug is located must meet the requirement - from +2 °C to +8 °C. It is necessary to exclude exposure to direct sunlight and freezing of the drug.

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Shelf life

The concentrate of the solution for infusions Navelik has a shelf life of two years. After this period, the use of the drug is strictly prohibited. The physical and chemical stability of the drug after its dilution in 0.9% sodium chloride or 5% glucose is observed for 24 hours. During 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 use after dilution.

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