Vero Vincristine (Vero-Vincristine)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVincristineVincristine
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    • Dosage form: & nbspsolution for intravenous administration
    Composition:

    In 1 ml of solution contains:

    Active substance: vincristine sulfate 0.0005 g;

    Excipients: mannitol, nipagin, nipazol, acetic acid, sodium acetate, water for injection.

    Description:Transparent or with light opalescence, colorless or slightly colored liquid.
    Pharmacotherapeutic group:Antitumor agent - alkaloid
    ATX: & nbsp

    L.01.C.A.02   Vincristine

    Pharmacodynamics:

    Vincristine - alkaloid vinca pink, refers to cytostatic chemotherapeutic agents. Vincristine binds to the protein-tubulin and leads to a violation of the microtubular apparatus of the cells and to the rupture of the mitotic spindle. Suppresses mitosis in metaphase. It also prevents the metabolism of glutamate and the possible synthesis of nucleic acid, has an immunosuppressive effect.

    Pharmacokinetics:

    After intravenous administration vincristine quickly distributed in the tissues of the body.About 90% of the drug binds to plasma proteins. Vincristine metabolized in the liver and excreted mainly with bile; 70-80% of the drug is found in feces in the unchanged state and in the form of metabolites, from 10 to 20% of the drug is detected in the urine, the connection with the shaped elements of the blood is 15%. The initial, middle and final half-life is 5 minutes, 2.3 hours and 85 hours, respectively. The terminal elimination half-life can range from 19 to 155 hours. Vincristine poorly penetrates the blood-brain barrier.

    Indications:

    Use strictly according to the doctor's prescription!

    In combination with other antitumor drugs, Vero-vincristine is used in acute leukemia, Hodgkin's disease and other lymphomas, Wilms tumor, rhabdomyosarcoma, neuroblastoma, myeloma, Kaposi's sarcoma, sarcomas of bones and soft tissues, small cell lung cancer, chorio carcinoma of the uterus, brain tumors. It is also used for idiopathic thrombocytopenic purpura (with resistance to corticosteroids and ineffectiveness of splenectomy).

    Contraindications:

    - Acute infectious diseases of viral, fungal or bacterial nature (including chicken pox, shingles);

    - depression of bone marrow function (leukopenia - below 40,000 / μL, granulocytopenia - less than 750 / μL, thrombocytopenia - platelet count below 120,000 / μL);

    hypersensitivity to vincoalkaloids;

    - pregnancy and lactation;

    - neurodystrophic diseases (in particular, the dimielinized form of the Charcot-Marie-Toot syndrome).

    Carefully:

    With hyperbilirubinemia, mechanical jaundice, oppression of bone marrow hematopoiesis (including on the background of concomitant radiation or chemotherapy, bone marrow infiltration by tumor cells), previous radiation therapy (hepatobiliary region and spinal cord region), hyperuricemia (especially manifested by gout or urate nephrolithiasis) , liver failure, old age (neurotoxic reactions may be more pronounced).

    Dosing and Administration:

    Intrathecal injection of vincristine can lead to death!

    Vero-vincristine is administered strictly intravenously at intervals of 1 week. The duration of the injection should be approximately 1 minute.

    When administering, care must be taken to avoid extravasation.

    The dose is selected individually.

    The average dose is:

    - for adults: 1.4 mg / m2 body surface, single dose should not exceed 2 mg;

    - for children: 2 mg / m2 surface of the body. For children weighing up to 10 kg the initial dose should be 0.05 mg / kg per week.

    In patients with impaired hepatic function and bilirubin concentration in the blood plasma above 51.3 μmol / l, a dose reduction of 50%

    Side effects:

    From the side of the central nervous system and peripheral nervous system: seizures with increased blood pressure, paresthesia, neurotic pain, decreased muscle strength, loss of tendon reflexes, ataxia, headache, depression, hallucinations, sleep disorders, diplopia, ptosis, transient blindness and optic atrophy.

    Neurotoxicity is a dose limiting factor.

    From the gastrointestinal tract: nausea, vomiting, stomatitis, constipation, paralytic ileus (especially common in children), abdominal pain, necrosis of the small intestine and / or perforation, diarrhea.

    From the urinary system: polyuria, dysuria, urinary retention due to atony of the bladder, edema.

    From the cardiovascular system: increase or decrease in blood pressure.In patients with previously irradiated mediastinum with the use of polychemotherapy with the inclusion of Vero-vincristine, angina and myocardial infarction may occur.

    From the respiratory system: acute dyspnoea and severe bronchospasm (observed with vincristine with mitomycin C).

    From the endocrine system: rarely there is a syndrome caused by a violation of the secretion of antidiuretic hormone (ADH), which is characterized by a large release of sodium in the urine and causes hyponatremia. In this case, there are no signs of damage to the kidneys and adrenal glands, dehydration, azotemia and swelling.

    On the part of the hematopoiesis system: rarely can there be moderate leukopenia, thrombocytopenia and anemia.

    Local Reactions: if the product gets under the skin, phlegmon, phlebitis, necrosis may develop.

    Other: alopecia, rash, amenorrhea, azoospermia.

    Overdose:

    In case of an accidental overdose, one should expect an increase in the side effects of Vero-vincristine. The specific antidote is not known.

    Treatment - symptomatic: restriction of fluid intake, the appointment of diuretics (for the prevention of ADH secretion syndrome),the use of phenobarbital (to prevent seizures), the use of enemas and laxatives (prevention of intestinal obstruction). It is also necessary to monitor the activity of the cardiovascular system and carry out hematological control.

    Hemodialysis is ineffective.

    In addition to the above, leucovorin can be given at a dose of 100 mg intravenously every 3 hours for 24 hours and then every 6 hours for at least 48 hours.

    Interaction:

    Vero-vincristine can reduce the anticonvulsant effect of phenytoin.

    When used simultaneously with neurotoxic drugs (isoniazid, itraconazole, nifedipine) there is an increase in side effects from the nervous system.

    With simultaneous application, Vero-vincristine weakens the effect of anti-gouty drugs.

    When used simultaneously with uricosuric agents, the risk of nephropathy increases.

    When administered in combination with mitomycin C, Vero-vincristine can cause severe bronchospasm.

    If it is necessary to use the drug in combination with LAsparaginase Vero-vincristine should be administered 12 to 24 hours before application. L-asparhinase.Assigning asparaginase before the introduction of Vero-vincristine can disrupt its excretion from the liver.

    Simultaneous use of Vero-vincristine with other mielodepressive drugs and prednisolone may increase oppression of bone marrow hematopoiesis.

    Special instructions:

    - Intrathecal injection of Vero-vincristine can lead to death.

    - During treatment should be carried out regular hematological control. In case of detection of leukopenia with the introduction of repeated doses, special care should be taken. With an increase in the concentration of uric acid, alkalinization of urine and the administration of inhibitors of xanthine oxidase (allopurinol). When the activity of hepatic samples is increased, the dose of Vero-vincristine should be reduced. Periodically, the concentration of sodium ions in serum should be determined. For the correction of hyponatremia, the administration of appropriate solutions is recommended.

    Special control is given to patients who have a history of neuropathy.

    - Any complaint of pain in the eyes or a decrease in vision requires a careful ophthalmological examination.

    - Avoid contact with Vero-Vincristine solution in the eyes.If this happens, it is necessary to rinse abundantly and thoroughly wash eyes with plenty of liquid.

    - With an extravasal injection, the injection should be stopped immediately, and the remainder should be injected into another vein. The feeling of local discomfort can be minimized by local administration of hyaluronidase and the use of mild cold or cold compresses.

    - When consuming large amounts of fluid, care must be taken because of the possible risk of developing a syndrome of inappropriate ADH secretion, which is eliminated when fluid intake is restricted.

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

    Neurotoxicity Vero-vincristine can adversely affect the ability to drive a vehicle, therefore during the period of treatment it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Solution for intravenous administration, 0.5 mg / ml.
    Packaging:

    0.5 mg in 1 ml; 2 ml in vials of colorless or dark glass.

    For 1, 5 or 10 bottles in a pack of cardboard with instructions for medical use.

    Storage conditions:

    At a temperature of 2 to 8 ° C, in a dark place out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiration date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002383 / 01
    Date of registration:02.04.2008 / 29.07.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp30.01.2017
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