Rubomycin (Rubomycin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDaunorubicinDaunorubicin
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  • Rubomycin
    lyophilizate in / in 
    SPbNIIVS FMBA, FSUE     Russia
    • Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
    Composition:

    One bottle contains:

    active substance: daunorubicin hydrochloride 20 mg [in terms of daunorubicin];

    Excipients: no.

    Description:A porous mass of red color. It is hygroscopic.
    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 Actinomyces coeruleorubidus, with cytostatic action. It acts on the S phase of mitosis. It blocks the matrix function of DNA, disrupting the synthesis of nucleic acids and protein.

    Pharmacokinetics:

    It has pronounced cumulative properties. After intravenous administration, it is quickly distributed in the body, especially in the kidneys, spleen, liver and heart, in the form of daunorubicin and metabolites. 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 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; marked bone marrow suppression; severe violations of the liver and / or kidney function; decompensated heart disease; pregnancy and the period of breastfeeding.

    Carefully:

    In acute infectious diseases of the viral (including chicken pox, shingles), fungal or bacterial nature (risk of serious complications and generalization of the process); diseases in which there is an increased risk of hyperuricemia (gout or urate nephrolithiasis).

    Dosing and Administration:

    Rubomycin is part of many chemotherapy regimens, and therefore in each individual case should be guided by data from specialized literature.

    Rubomycin is administered only intravenously.

    Dose regimens:

    a) 50-100 mg / m2 1 time in 3 weeks;

    b) 30-60 mg / m2 daily 3-5 days. Intervals between cycles of 7-15 days;

    c) 30-60 mg / m2 1 time in 5-7 days. Course dose of 500 mg and above;

    d) 10 mg / m2 daily up to a total dose of 500 mg;

    e) 180 mg / m2 1 time per month (high dose regimen).

    Rules for the preparation of a solution for intravenous administration

    The contents of the vial are dissolved in 4 ml of sterile 0.9% sodium chloride solution or sterile water for injection. The required dose of Rubomycin is taken from the vial with the prepared solution into a syringe containing 10-15 ml of a 0.9% solution of sodium chloride for injection and then injected for 2-3 minutes into the tube of the system through which a rapid intravenous infusion of 5% dextrose solution (glucose) or 0.9% solution of sodium chloride for injection. Introduction by intravenous infusion is not recommended because of the irritating effect on the veins and the risk of developing thrombophlebitis.

    Side effects:

    On the part of the hematopoiesis system: anemia, leukopenia, thrombocytopenia. Leukopenia is observed in almost all patients. The lowest number 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, diarrhea, esophagitis, stomatitis.

    From the cardiovascular system: chronic heart failure (arrhythmias, dyspnea, edema 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). Rare-myocarditis, pericarditis.

    From the side of the reproductive system: amenorrhea, azoospermia.

    Local Reactions: phlebitis; when extravasation - pain at the injection site, cellulite or necrosis of surrounding tissues.

    Other: alopecia, allergic reactions, hyperuricemia, reddish urine staining, hyperpigmentation or reddening of previously irradiated skin areas, development of opportunistic infections, fever, lower back pain or side pain.

    Overdose:

    Symptoms: manifestations of cardiotoxicity (pain in the heart, tachycardia, ECG changes, lowering of blood pressure, myocarditis), severe myelosuppression (granulocytopenia), weakness, nausea, vomiting, headache, loss of appetite.

    Antidote for use in case of an overdose Rubomycin is unknown. Treatment is symptomatic.

    Interaction:

    Compatible with vincristine, cyclophosphamide, 6-mercaptopurine, prednisolone, asparaginase, 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 increased, while the total dose of daunorubicin should not exceed 400 mg / m2.

    The use of daunorubicin in patients who had previously received doxorubicin, the risk of cardiotoxicity increases. The total cumulative dose of doxorubicin and daunorubicin should not exceed 550 mg / m2.

    With the use of daunorubicin, the concentration of uric acid in the blood can increase, so that in the treatment of hyperuricemia and gout, correction of the antipodal agentsallopurinol, probenecid, sulfinpyrazone); the use of uricosuric antidotal drugs may increase the risk of nephropathy, so the preferred drug for preventing or eliminating the associated with the use of daunorubicin hyperuricemia may be allopurinol.

    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:

    Patients receiving rubomycin should be supervised by a physician with experience in chemotherapy for malignant diseases.

    - Before and during each cycle of therapy, a blood test should be performed with a count of the leukocyte count.

    - 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 a too rapid introduction of Rubomycin.

    - During treatment with Rubomycin, you should avoid drinking alcohol and taking acetylsalicylic acid 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 concentration of uric acid and creatinine in serum. To prevent hyperuricemia, a generous drink is recommended, if necessary - allopurinol and alkalinization of urine.

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

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

    The drug can affect the ability to drive vehicles and work with other mechanisms, since the drug can cause nausea and other side effects that can affect these abilities.

    Form release / dosage:

    Lyophilizate for the preparation of a solution for intravenous administration, 20 mg.

    Packaging:

    In vials of 20 mg.

    For 10 bottles with the attached instructions for use in a cardboard box.

    Storage conditions:

    In a dry, dark place at a temperature of 12 to 20 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001085
    Date of registration:03.11.2011
    Date of cancellation:2016-11-03
    The owner of the registration certificate:SPbNIIVS FMBA, FSUE SPbNIIVS FMBA, FSUE Russia
    Manufacturer: & nbsp
    Representation: & nbspSPbNIIVS FMBA, FSUESPbNIIVS FMBA, FSUERussia
    Information update date: & nbsp29.12.2015
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