Daunorubicin-LENS® (Daunorubicin-LANS®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDaunorubicinDaunorubicin
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  • Daunorubicin-LENS®
    lyophilizate in / in 
    VEROPHARM SA     Russia
  • Daunorubicin-LENS®
    solution in / in 
    VEROPHARM SA     Russia
  • Rubomycin
    lyophilizate in / in 
    OMUTNINSK SCIENTIFIC EXPERIMENTAL-INDUSTRIAL BASE, OJSC     Russia
  • Rubomycin
    lyophilizate in / in 
    SPbNIIVS FMBA, FSUE     Russia
    • Dosage form: & nbspsolution for intravenous administration
    Composition:

    Per 1 bottle

    active substance: daunorubicin hydrochloride (rubomycin hydrochloride) - 21.36 mg, - 42.73 mg in terms of 100% daunorubicin base - 20 mg, - 40 mg.

    Excipients: Mannitol (mannitol) - 80.0 mg, - 160.0 mg.

    Description:

    Transparent liquid of red or orange-red color.

    Pharmacotherapeutic group:Antitumor agent - antibiotic
    ATX: & nbsp

    L.01.D.B   Anthracyclines and related drugs

    L.01.D.B.02   Daunorubicin

    Pharmacodynamics:Antitumor antibiotic anthracycline, produced Streptomyces coeruleorubidis, with cytostatic action. Acts on Sphase of mitosis. It blocks the matrix function of DNA, disrupting the synthesis of nucleic acids and protein.
    Pharmacokinetics:

    After intravenous administration, it circulates in the blood for several minutes. 30 minutes after the injection, the highest concentrations are recorded in the spleen, lungs, heart muscle and kidneys. Does not penetrate the blood-brain barrier.Metabolised in the liver with the formation of an active metabolite daunorubicinol. The half-life in the initial phase is 45 minutes; in the final phase - for daunorubicin 18.5 h, for daunorubicinol 26.7 h. It is excreted mainly with bile. 25% is excreted by the kidneys.

    Indications:

    - Acute lymphoblastic and non-lymphoblastic (myeloblastic, monoblast, erythroblast) leukemia;

    - blast crisis of chronic myelogenous leukemia;

    - non-Hodgkin's lymphomas;

    - neuroblastoma;

    - choriocarcinoma of the uterus.

    Contraindications:

    - Hypersensitivity to daunorubicin or other constituents of the drug, as well as to other anthracyclines or anthracenedions;

    - marked bone marrow suppression;

    - severe violations of the liver and / or kidney function;

    - decompensated heart disease;

    - previous chemotherapy with other anthracyclines or anthracenedions in the limiting total doses;

    - Pregnancy and the period of breastfeeding.
    Carefully:

    When oppression of bone marrow hematopoiesis (including against the background of concomitant radiation or chemotherapy, bone marrow infiltration by tumor cells); in acute infectious diseases of the viral (incl.chicken pox, shingles), fungal or bacterial nature (risk of severe complications and generalization of the process); diseases in which there is an increased risk of hyperuricemia (gout or urate nephrolithiasis); When patients are elderly and children.

    Dosing and Administration:

    Daunorubicin-LENS® is administered strictly intravenously.

    When choosing the dose and the mode of administration of the drug in each individual case, one should use the data of the specialized literature.

    Usually the drug is administered at a dose of 30-60 mg / m2 daily for 3 days or 20-40 mg / m2 daily for 5 days every 3-4 weeks to a total dose of 300 mg / m2. The maximum total dose is 600 mg / m2.

    For patients who had previously received radiotherapy for the thoracic region, the maximum total dose is 450 mg / m2.

    For patients who have previously received doxorubicin, the total combined dose of doxorubicin and daunorubicin should not exceed 550 mg / m2.

    Rules for the preparation of a solution for intravenous administration

    The required dose of daunorubicin-LENS is diluted with 0.9% sodium chloride solution or water for injection to a concentration of 1-2 mg / ml.The drug is injected within 2-3 minutes into the tube of the system through which a rapid intravenous infusion of 5% dextrose (glucose) solution or 0.9% sodium chloride solution for injection is administered. Introduction by intravenous infusion is not recommended because of the irritating effect on the veins and the risk of developing thrombophlebitis.

    Patients with impaired renal function dose reduced - at a concentration of creatinine in the serum above 0.3 mmol / l it is recommended to use half the usual dose.

    When a violation of liver function and the concentration of bilirubin in the blood serum 20.5-51.3 μmol / l should be used 3/4 of the usual dose, and at a bilirubin concentration higher than 51.3 μmol / l - half the usual dose of the drug.

    Side effects:

    On the part of the hematopoiesis system: anemia, leukopenia, neutropenia, thrombocytopenia. Leukopenia is observed in almost all patients. The lowest level of leukocytes is observed 10-14 days after the administration of the drug. Recovery usually occurs within 21 days after administration.

    On the part of the digestive system: nausea, vomiting, anorexia, diarrhea; ulcerative esophagitis and stomatitis.

    From the side of the cardiovascular system: congestive heart failure (arrhythmias, dyspnea, swelling of the feet and ankles) usually develops at a total dose of more than 550 mg / m2 (450 mg / m2 in patients who were previously exposed to the thorax, in elderly people and in patients with heart disease). Rarely - myocarditis, pericarditis.

    On the part of the reproductive system: amenorrhea, azoospermia.

    From the urinary system: hyperuricaemia (painful or difficulty urinating, cystitis), reddish urine staining.

    Local reactions: phlebitis; when extravasation - pain at the injection site, inflammation of subcutaneous fat, necrosis of surrounding tissues.

    Other: alopecia, allergic reactions, hyperpigmentation or redness earlier irradiated skin areas, the development of secondary infections, headache, fever, pain in the lower back and side.

    Overdose:

    In case of an overdose, the above adverse reactions should be expected to increase. The antidote is unknown. Treatment is symptomatic.

    Interaction:

    Compatible with vincristine, cyclophosphamide, 6-mercaptopurine, prednisolone, Lasparaginase, methotrexate.

    When used simultaneously with other myelotoxic drugs or radiotherapy, additive inhibition of bone marrow function is possible.

    Hepatotoxic drugs (incl. methotrexate) increase the risk of impaired liver function.

    With the simultaneous use of cyclophosphamide or irradiation of the mediastinal region, cardiotoxic action may be enhanced.

    The use of daunorubicin in patients who had previously received doxorubicin, the risk of cardiotoxicity increases.

    Urikozuric antidotal drugs increase the risk of developing nephropathy.

    Pharmaceutically incompatible with heparin and dexamethasone (precipitation); strongly alkaline solutions (pH more than 8) (formation of a weak glycosidic bond); preparations containing benzyl alcohol (premature release of the active substance).

    With the introduction of live viral vaccines, replication of the vaccine virus and the increase in side effects, inactivated vaccines, may result in reduced production of antiviral antibodies.

    Special instructions:

    Treatment should be conducted under the supervision of a specialist who has experience of antitumor chemotherapy.

    Before and during the treatment it is necessary to control the picture of peripheral blood, the functional state of the kidneys, liver, cardiovascular system (echocardiogram, ECG). Violation of myocardial contractility, symptoms of chronic heart failure, etc. cardiotoxic effects may appear in a few months or years after the end of treatment (especially in children), so the control of the condition of the cardiovascular system should be carried out for a long time.

    When the first signs of extravasation appear (burning or soreness at the injection site), the drug should be discontinued immediately. The remaining drug should be injected into another vein.

    A rush of blood to the face or the appearance of erythematous bands on the skin along the vein indicates the too rapid introduction of Daunorubicin-LENS®.

    During treatment with Daunorubicin-LENS®, alcohol and aspirin should be avoided because of the risk of gastrointestinal bleeding.

    In connection with the possible development of hyperuricemia related to tumor lysis syndrome, it is recommended that patients during the therapy determine the level of uric acid and creatinine in serum.To prevent hyperuricemia, a generous drink is recommended, if necessary - allopurinol and alkalinization of urine. Hyperuricemia may cause a decrease in the effectiveness of tubular secretion blockers.

    It is recommended to use reliable methods of contraception during the treatment of any of the sexual partners.

    During the period of treatment, vaccination with viral vaccines is not recommended.

    Form release / dosage:Solution for intravenous administration, 5 mg / ml.
    Packaging:

    For 20 mg / 4 ml or 40 mg / 8 ml in bottles of light-protective glass.

    1 bottle with instructions for use in a pack of cardboard.

    For 5 or 10 bottles together with instructions for use in a pack with cardboard partitions.

    For 25, 30, 50, 85 or 100 bottles with application instructions, at the rate of one per 10 bottles, in a box of cardboard (for hospitals).

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001889/07
    Date of registration:02.08.2007 / 29.07.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.03.2017
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