Clinical and pharmacological group: & nbsp

Antineoplastic agents

Included in the formulation
  • Velbin
    concentrate d / infusion 
    AKTAVIS GROUP, AO     Iceland
  • Vinelbin
    concentrate d / infusion 
  • Winkater
    concentrate d / infusion 
  • Vinorelbine
    concentrate d / infusion 
    FARM STANDART, OJSC     Russia
  • Vinorelbine
    concentrate d / infusion 
    BELMEDPREPARATY, RUP     Republic of Belarus
  • Vinorelbine medak
    concentrate d / infusion 
    medac GmbH     Germany
  • Vinorelbine-Teva
    concentrate d / infusion 
  • Marex
    concentrate d / infusion 
    LENS-PHARM, LLC     Russia
  • Navelbin
    capsules inwards 
  • Navelbin
    concentrate d / infusion 
  • Cituvin®
    concentrate d / infusion 
    BIOCAD, CJSC     Russia
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    L.01.C.A.04   Vinorelbine

    Pharmacodynamics:

    An antitumor agent from the group of cytostatics is a semisynthetic derivative of one of the alkaloids of the vinca rosea - vinblastine. Like vinblastine, vinorelbine blocks the mitosis of cells at the stage of metaphase due to binding to the protein tubulin.

    Pharmacokinetics:

    After intravenous administration vinorelbine widely distributed in tissues, the volume of distribution is more than 40 l / kg.Binding to plasma proteins is moderate - 13.5%, with platelets - high - 78%.

    The kinetics of vinorelbine in plasma is three-phase. The average half-life of the active substance in the final phase is 40 hours. The system clearance is 1.3 l / h / kg. It is excreted mainly with bile.

    Indications:

    Breast cancer, lung cancer (except for small cell).

    II.C50.C50   Malignant neoplasm of breast

    II.C30-C39.C34   Malignant neoplasm of bronchi and lungs

    Contraindications:

    Pronounced violations of the liver, severe granulocytopenia and thrombocytopenia, pregnancy, lactation.

    Carefully:

    Use with caution vinorelbine in patients with impaired liver function, in this case, the dose is reduced. Against the background of the use of vinorelbine, x-ray therapy is not prescribed for the liver region.

    Pregnancy and lactation:

    Action category for the fetus by Food and Drug Administration (US Food and Drug Administration) - D.

    Contraindicated in pregnancy.

    For the duration of treatment, breastfeeding should be discontinued.

    Dosing and Administration:

    Intravenously (within 5-10 minutes), previously diluted with 0.9% solution of sodium chloride or 5% solution of dextrose. Dose with monotherapy - 25-30 mg / m2 1 time a week.With polychemotherapy, the dose and frequency of vinorelbine administration depend on the specific program of antitumor therapy.

    Side effects:

    On the part of the hematopoiesis system: granulocytopenia, anemia.

    From the side of the peripheral nervous system: it is possible to reduce (down to full extinction) osteosusillary reflexes; rarely paresthesia; with prolonged use - increased fatigue of the muscles of the lower extremities.

    From the digestive system: nausea, less often - vomiting; due to the action of the drug on vegetative innervation of the intestine - constipation; in some cases - paresis of the intestine; rarely - paralytic intestinal obstruction.

    Allergic reactions: difficulty breathing, bronchospasm; in isolated cases - skin reactions.

    Other: alopecia, pain in the jaw.

    Local reactions: phlebitis.

    Overdose:

    Symptoms: acute granulocytopenia with a risk of developing infectious complications, peripheral neurotoxicity.

    Treatment: hospitalization of the patient, transfusion of the canned granulocyte mixture, the introduction of colony-stimulating factors for the improvement of granulocytopoiesis, antibacterial therapy of infection. The specific antidote is unknown.

    Interaction:

    With simultaneous use with mitomycin C, the risk of respiratory depression, bronchospasm, especially in predisposed patients, increases; with cisplatin - an increase in the frequency of development of toxic reactions.

    Special instructions:

    Treatment vinorelbine should be carried out only in a specialized hospital by personnel who have experience of treatment with chemotherapeutic agents. Before the beginning of treatment, and also before each next application of vinorelbine, control of the peripheral blood composition is necessary. If the number of granulocytes is less than 2000 / mkl, another injection is not performed, postponing it until a safe level of granulocytes is reached.

    Use with caution vinorelbine in patients with impaired liver function, in this case, the dose is reduced.

    Against the background of the use of vinorelbine, x-ray therapy is not prescribed for the liver region.

    When intravenous infusion do not allow extravasation. The entry of vinorelbine into the veins surrounding the vein leads to the appearance of pain, inflammation, in severe cases - necrosis.

    Avoid contact with vinorelbine solution in the eyes.

    Instructions
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