Active substanceVinblastineVinblastine
Similar drugsTo uncover
  • Vinblastine-LENS®
    lyophilizate in / in 
    LENS-PHARM, LLC     Russia
  • Vinblastine Richter
    lyophilizate in / in 
    GEDEON RICHTER, OJSC     Hungary
  • Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
    Composition:

    Active substance: vinblastine sulfate 5 mg.

    Excipients: no.

    Solvent composition: sodium chloride, water for injection.

    Description:

    Lyophilizate: porous mass of white or yellowish white color.

    Solvent: transparent clear solution without mechanical impurities.

    Pharmacotherapeutic group:Antitumor agent - alkaloid
    ATX: & nbsp

    L.01.C.A.01   Vinblastine

    L.01.C.A   Vinca alkaloids and its analogues

    Pharmacodynamics:

    Vinblastine is an alkaloid isolated from a plant of the genus Vinca Periwinkle. Vinblastine blocks mitotic division of cells in the metaphase of the cell cycle. The action exerts, by contacting microtubules, by inhibiting the formation of mitotic spindles. In tumor cells, the synthesis of DNA and RNA selectively inhibits the inhibition of DNA-dependent RNA polymerase.

    Pharmacokinetics:After intravenous administration, it is quickly distributed in the tissues. Does not penetrate the blood-brain barrier. Connection with proteins - 80%. Metabolised in the liver.It is excreted from the body in three phases with half-lives of duration (average values) of 3.7 minutes, 1.6 hours and 24.8 hours, mainly with bile,, respectively. A small amount of vinblastine in unchanged form and in the form of metabolites is determined in urine.
    Indications:
    - Hodgkin's disease;

    - non-Hodgkin's lymphomas;

    - chronic lymphocytic leukemia;

    - germinogenous tumors of testis and ovaries;

    - cancer of the bladder;

    - Kaposi's sarcoma;

    - the Letterer-Sieve disease (histiocytosis X);

    - mushroom mycosis (generalized stages).

    Contraindications:

    - Hypersensitivity to vinca alkaloids or to any other component of the drug;

    - marked suppression of bone marrow function;

    - bacterial and viral infections;

    - pregnancy and lactation.

    Carefully:

    A recent or simultaneous myelosuppressive chemotherapy or radiotherapy, leukopenia, thrombocytopenia, liver dysfunction, hyperuricemia, elderly age.

    Dosing and Administration:

    Exclusively for intravenous administration (extravasation should be avoided). It is forbidden to enter intrathecally!

    The dose is selected taking into account the individual characteristics of the patient and thechemotherapy regimens, guided by data from specialized literature.

    The usual dose is:

    - for adults: 5.5-7.4 mg / m2 body surface;

    - for children: from 3.75 to 5 mg / m2 surface of the body.

    The drug is administered once a week or once every 2 weeks.

    Modes of a gradual increase in weekly doses can also be used:

    - for adults: the first dose is 3.7 mg / m2, each subsequent weekly dose, with a leukocyte count of at least 4000 / μL blood, is increased by 1.8-1.9 mg / m2 body surface until the maximum single dose of 18.5 mg / m2;

    - for children: weekly increase in doses by 1.25 mg / m2 carried out on the same principle as in adults, starting with an initial dose of 2.5 mg / m2 body surface and up to a maximum dose of 12.5 mg / m2.

    Doses are increased until the number of white blood cells decreases to 3000 / μl, or the size of the tumor decreases, or the maximum single dose is not reached, and then passes to maintenance doses that are less than the final value of the last adult dose for 1,8- 1.9 mg / m2 and for children at 1.25 mg / m2 The surface of the body is injected once every 7-14 days.

    At a level of bilirubin in the serum above 3 mg / 100 ml (50 μmol / l), a dose reduction of 50% is recommended.

    Apply a freshly prepared solution, for which the contents of the vial with lyophilized powder are dissolved in the applied solvent. Immediately before the introduction of the drug, if necessary, it can be diluted with 0.9% sodium chloride solution (other solutions not recommended) to a concentration of 1 mg / 1 ml.

    Side effects:

    On the part of the hematopoiesis system: most often leukopenia, granulocytopenia (the lowest level is observed 5-10 days after the last administration, the complete recovery usually occurs within the next 7-14 days); less often - thrombocytopenia, anemia.

    On the part of the digestive system: stomatitis, pharyngitis, decreased appetite, nausea, vomiting, constipation, diarrhea, abdominal pain, paralytic intestinal obstruction, hemorrhagic enterocolitis, bleeding from previously diagnosed gastrointestinal ulcers.

    From the nervous system: paresthesia, decrease or loss of deep tendon reflexes, peripheral neuritis, depression, headache, convulsions, dizziness, diplopia, weakness, pain in the jaw region, neuritis of the VIII pair of cranial nerves (partial or total deafness, dizziness, nystagmus).

    From the cardiovascular system: increased blood pressure; myocardial ischemia, including angina pectoris or myocardial infarction (usually with simultaneous use with bleomycin and cisplatin); microangiopathy (Raynaud's syndrome with concomitant use of bleomycin);

    From the respiratory system: bronchospasm (usually, with simultaneous use with mitomycin) with acute respiratory failure, cyanosis, dyspnea and often with the formation of pulmonary infiltrates and pneumonitis.

    From the skin and skin appendages: alopecia, urticaria.

    Local reactions: pain or redness at the injection site, phlebitis; when the product gets under the skin - inflammation of the subcutaneous fat, and, possibly, necrosis.

    Other: hyperuricemia, uric acid nephropathy; weakness, increased fatigue, myalgia, ossalgia, pain in the area of ​​tumor nodes; azoospermia and amenorrhea (sometimes irreversible). When appointing doses above recommended, the syndrome of inadequate secretion of antidiuretic hormone is noted.

    Overdose:

    Symptoms: the development of side effects in a more pronounced form.

    Treatment: there is no antidote, symptomatic and maintenance therapy.The following measures are recommended: with the development of the syndrome of inadequate secretion of antidiuretic hormone - restriction of fluid intake and the appointment of diuretics; the appointment of anticonvulsants; control of cardiovascular function; careful monitoring of the blood picture, if necessary - blood transfusion; the use of enemas and laxatives (prevention of intestinal obstruction).

    Hemodialysis is ineffective in case of an overdose of Vinblastine.

    Interaction:
    It is prohibited to use neurotoxic drugs concomitantly (isoniazid, L-asparaginase).

    Care should be taken when ototoxic drugs are used concomitantly.

    With simultaneous use with mitomycin, care should be taken because of the possible development of acute bronchospasm.

    With simultaneous admission with vinblastine plasma concentration of phenytoin decreases, which can lead to a decrease in its anticonvulsant activity.

    With concomitant use with bleomycin, the development of Raynaud's syndrome is possible. When vinblastine was used in combination with bleomycin and cisplatin, cases of myocardial infarction and cerebral circulation disorders were noted.

    When used in combination with preparations containing platinum, the risk of damage to the VIII pair of CHMN increases.

    Anti-gouty drugs (allopurinol, colchicine, probenicide, sulfinpyrazone) can cause an increase in the level of uric acid in the blood; may need to adjust their doses in order to prevent the development of hyperuricemia; for the prevention and treatment of hyperuricemia caused by vinblastine, it is preferable to use allopurinol in order to avoid the development of acute urinary nephropathy as a result of the use of uricosuric antidotal drugs.

    Thrombocytopenic and leukopenic effects of vinblastine intensify drugs, which in turn are also capable of such actions if their application is performed simultaneously with vinblastine or precedes it; it may be necessary to adjust the dose of vinblastine to reflect the pattern of blood.

    The interval between stopping vinblastine treatment and vaccination with an attenuated or live virus vaccine depends on the type and degree of drug immunosuppression, the underlying disease and other factors, and lasts 3-12 months.

    Special instructions:

    Treatment with Vinblastine can be done only under the supervision of a doctor who has experience in the use of antitumor chemotherapy

    Before starting the injection, make sure that the needle is in the vein. When vinblastine is extravaginated, the drug should be discontinued immediately; The remaining solution with the drug must be injected into another vein. It is recommended to introduce hyaluronidase into the affected area.

    During treatment, regular monitoring of the number of leukocytes, platelets and hemoglobin level is necessary.

    With a decrease in the number of white blood cells to 3000 / μl treatment should be discontinued.

    In the process of treatment, it is also necessary to monitor the activity of hepatic enzymes and serum levels of bilirubin.

    When signs of neurointoxication appear, Vinblastine should be discontinued.

    To avoid acute urinary nephropathy, you should regularly monitor the level of uric acid in the blood serum and ensure sufficient fluid intake for patients. If necessary, it is recommended that allopurinol. Women of childbearing age during treatment with vinblastine should use non-hormonal reliable methods of contraception.

    It is prohibited to carry out vaccination with live viral vaccine of patients undergoing treatment with vinblastine.

    In case of accidental ingestion of vinblastine into the eye, immediately rinse thoroughly with water to prevent severe irritation or possible ulceration of the cornea.

    Effect on the ability to drive transp. cf. and fur:

    Some side effects of the drug (neurotoxicity) can adversely affect the ability to drive and perform potentially dangerous activities that require increased concentration and speed of psychomotor reactions. In this connection, care should be taken when driving vehicles and mechanisms.

    Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration, 5 mg.
    Packaging:

    In brown glass vials of 5 mg with the applied solvent (0.9% solution of sodium chloride) in ampoules of colorless glass of 5 ml.

    1 bottle and 1 ampoule in a plastic pallet.

    10 plastic pallets in a cardboard box with instructions for use.

    Storage conditions:

    At a temperature of 2-8 ° C, in a place protected from light.

    Keep out of the reach of children.
    Shelf life:

    For lyophilizate: 2 years.

    For solvent: 5 years

    The expiration date of the lyophilizate is indicated on the cardboard bundle.

    Do not use the drug with expired shelf life.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013919 / 01
    Date of registration:15.08.2007
    Expiration Date:Unlimited
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp16.02.2017
    Illustrated instructions
      Instructions
      Up