Rubomycin (Rubomycin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceDaunorubicinDaunorubicin
Similar drugsTo uncover
  • 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: & nbsplyophilizate for the preparation of a solution for intravenous administration
    Composition:

    1 bottle contains:

    active substance: daunorubicin hydrochloride 21.4 mg,

    [in terms of daunorubicin] - 20.0 mg.

    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 Streptomyces coeruleorubidus subsp. rubomycini, with cytostatic action. Acts on Sphase of mitosis. It blocks the matrix function of DNA, disrupting the synthesis of nucleic acids.
    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 of 45 minutes, in the final phase - daunorubicin for 18.5 h, 26.7 h daunorubicinol deduced mainly intestines, kidneys displayed 25%..

    Indications:

    Acute leukemia, blast crisis of chronic myeloid leukemia, non-Hodgkin's lymphoma, neuroblastoma, uterine choriocarcinoma.

    Contraindications:

    Hypersensitivity to daunorubicin or other components of the formulation, expressed as bone marrow depression, expressed by human liver and / or kidney disease, decompensated heart disease, prior anthracycline chemotherapy or other anthracenediones to limit cumulative doses; Hypersensitivity to daunorubicin or other components of the drug as well as other anthracyclines and anthracenediones, pregnancy and breastfeeding.

    Carefully:

    In acute viral infections (including varicella, herpes zoster), fungal or bacterial origin (the risk of severe complications and generalization process); diseases in which there is an increased risk of hyperuricemia (gout or urate nephrolithiasis),patients of advanced age.

    Pregnancy and lactation:

    Contraindicated in pregnancy and during breastfeeding.

    Dosing and Administration:

    Intravenously. Daunorubicin is included in many chemotherapy regimens, and therefore in each individual case should be guided by data from specialized literature.

    Dose regimens:

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

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

    c) 30-60 mg / m2 1 time from 5 to 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).

    Children in the first 5 days, daily 20 mg / m2. With good tolerability, the second cycle of treatment is performed after 7-10 days of interruption: every other day, 20-30 mg / m2. The intervals between the following courses of treatment are 2 to 3 weeks.

    When the liver and kidney function is impaired The dose of daunorubicin is reduced to 3/4 (with a bilirubin level of 20.5-51.3 μmol / L) or 1/2 (with a bilirubin level above 51.3 μmol / L or creatinine above 0.3 mmol / l).

    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 daunorubicin is taken from a vial with solution in 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% solution of dextrose (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:

    Allergic reactions: anaphylactic shock, anaphylactoid reactions.

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

    From the urinary system: nephrotic syndrome, uric acid nephropathy, reddish urine coloration.

    From the digestive system: nausea, vomiting, diarrhea, esophagitis, stomatitis, abdominal pain.

    From the hematopoiesis: anemia, leukopenia, thrombocytopenia, neutropenia. 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.

    From the side of the cardiovascular system: angina pectoris, chronic heart failure (arrhythmia, 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, myocardial infarction.

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

    Other: alopecia, hyperuricemia, hyperpigmentation or reddening of previously irradiated skin areas, development of opportunistic infections, fever, lower back pain or side pain, dehydration, "hot flashes", bleeding, increased bilirubin concentration in blood plasma, increased activity of aspartate aminotransferase and alkaline phosphatase.

    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 of daunorubicin is unknown.

    Treatment: symptomatic.

    Interaction:

    Compatible with vincristine, cyclophosphamide, 6-mercaptopurip, 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, increases the risk of cardiotoxic action. 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,therefore, the preferred drug for preventing or eliminating the hyperuricemia associated with daunorubicin 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 daunorubicin, should be under the supervision of a doctor who has experience in chemotherapy for malignant diseases.

    Before and during each cycle of therapy, a blood test should be performed to count the leukocyte formula and monitor the functions of the cardiovascular system, liver and kidneys.

    When the first signs of extravasation appear (burning or soreness at the injection site or other signs), the injection of daunorubicin should be stopped immediately, the needle should be left in place, after a short aspiration, remove it.The remaining drug should be injected into another vein. On the extravasation area it is recommended to apply ice for 15 minutes 4 times a day for 3 days. Careful observation is recommended for the patient. In the event of the appearance of blisters, ulcers and / or constant pain, it is necessary to discuss with a plastic surgeon the possibility of excision of a large area of ​​skin followed by a split skin flap transplant.

    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 daunorubicin.

    During the treatment with daunorubicin, alcohol and acetylsalicylic acid 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 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.

    With the development of pronounced myelosuppression, daunorubicin therapy, especially when used in combination with other antitumor drugs, should be discontinued before the restoration of bone marrow function. Usually it takes about 3 weeks.

    Nausea and vomiting that occur within the first few hours after taking the drug can be alleviated with antiemetic drugs.

    When using the drug should comply with all instructions adopted for the use of cytotoxic drugs. If they get on the skin or mucous membranes, they should be washed immediately and thoroughly with water, physiological solution.

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

    The drug may cause nausea, vomiting and other side effects, so you should be careful when driving vehicles or other mechanisms. When these undesirable phenomena appear, one should refrain from performing these activities.

    Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration, 20 mg.
    Packaging:

    By 20 mg of active substance in bottles with a capacity of 10 ml of neutral glass grade HC-1 or HC-3 but ISO 8362-1 ukuporennye rubber stoppers on ISO 8362-5, crimped with aluminum caps according to GOST R 51314-99.

    One bottle together with the instruction for use is packed in a pack of cardboard.

    Storage conditions:

    AT protected from light, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003248
    Date of registration:08.10.2015
    Date of cancellation:2020-10-08
    The owner of the registration certificate:OMUTNINSK SCIENTIFIC EXPERIMENTAL-INDUSTRIAL BASE, OJSC OMUTNINSK SCIENTIFIC EXPERIMENTAL-INDUSTRIAL BASE, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.12.2015
    Illustrated instructions
      Instructions
      Up