Daunorubicin (Daunorubicinum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Other antineoplastic agents

Included in the formulation
  • 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
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    L.01.D.B   Anthracyclines and related drugs

    L.01.D.B.02   Daunorubicin

    Pharmacodynamics:

    It is an anthracycline glycoside, which is most active in Sphase of the cell cycle, but the effect of the drug is not phase-specific. It has intercalating properties, due to which it inhibits the synthesis of DNA and RNA. It is also possible to disturb the spatial structure of DNA.

    Pharmacokinetics:

    Absorbed quickly and completely, does not penetrate the blood-brain barrier. After intravenous administration, it is quickly distributed in the body, especially in the kidneys, spleen, liver, heart. Metabolized in the liver, half-life of 18.5 hours, and metabolites of the drug - from 27 to 55 hours. Eliminated by the kidneys and gastrointestinal tract. The drug has pronounced cumulative properties.

    Indications:

    Wilms tumor, uterine chorioepithelioma, uterine choriocarcinoma, acute lymphoblastic and non-lymphoblastic (myeloblastic, monoblastous, erythroblast) leukemia, blast crisis of chronic myelogenous leukemia, lymphogranulomatosis, neuroblastoma, Ewing tumor, non-Hodgkin's lymphomas.

    ICD-10

    II.C40-C41.C41   Malignant neoplasm of bones and articular cartilages of other and unspecified sites

    II.C51-C58.C58   Malignant neoplasm of placenta

    II.C64-C68.C64   Malignant neoplasm of kidney, except for renal pelvis

    II.C69-C72.C71   Malignant neoplasm of brain

    II.C81-C96.C81   Hodgkin's disease [lymphogranulomatosis]

    II.C81-C96.C82   Follicular [nodular] non-Hodgkin's lymphoma

    II.C81-C96.C83   Diffuse non-Hodgkin's lymphoma

    II.C81-C96.C85   Other and unspecified types of non-Hodgkin's lymphoma

    II.C81-C96.C91.0   Acute lymphoblastic leukemia

    II.C81-C96.C92.0   Acute myeloid leukemia

    II.C81-C96.C92.1   Chronic myeloid leukemia

    II.C81-C96.C94.7   Other specified leukemia

    Contraindications:

    Age 65 years or older, gout, renal calculi in the anamnesis, hypersensitivity, leukopenia, thrombocytopenia, chronic heart failure, stomach / duodenal ulcer, pregnancy, lactation period.

    Carefully:

    Chronic liver and kidney disease, heart disease, gout, nephrolithiasis, chemotherapy with drugs with pronounced myelotoxic effect, with acute infectious diseases of the virus (including chicken pox, shingles), fungal or bacterial nature, children's age.

    Pregnancy and lactation:

    Category FDA - D. Controlled studies on humans were not conducted. Penetrates through the placental barrier. Possible development of fetal side effects observed in adults. It is recommended to avoid the use of antitumor, especially combined, chemotherapy in pregnancy, especially in the first trimester. In the presence of indications, it is necessary to relate the risk and benefit and take into account the mutagenic, carcinogenic and teratogenic potential of this drug. In view of the potential threat to the fetus (side effects, mutagenicity, carcinogenicity and teratogenicity), it is recommended that women of childbearing age with daunorubicin use contraceptives. There is no information on the penetration into breast milk. Due to the excretion of other anthracyclines in milk and the potential risk of unwanted effects on the baby,during treatment with daunorubicin, breastfeeding should be stopped.

    Dosing and Administration:

    Intravenously. Dosing regimen is set individually by the attending physician depending on the stage, the severity of the disease and the clinical parameters of the patient.

    Adults injected in a daily dose of 30-60 mg / m2 (0.8-1.5 mg / kg) daily for three days or at a dose of 20-40 mg / m2 (0.6-1 mg / kg) for five days. After 7-15 days, the course is repeated. Children - 25 mg / m2 1 time in 5-7 days. If the renal function is impaired, the dose of daunorubicin is reduced depending on the creatinine clearance.

    Side effects:

    From the cardiovascular system and blood: congestive heart failure (arrhythmias, dyspnea, swelling of the feet and ankles), leukopenia, thrombocytopenia (usually asymptomatic), anemia, granulocytopenia; rarely unusual bleeding or hemorrhage.

    From the skin: cellulite, alopecia, tissue necrosis, thrombophlebitis, recurrences of post-radiation erythema, redness along the vein, hyperpigmentation of the nail beds.

    From the side of the urinary tract: hyperuricemia or uric acid nephropathy, an increase in the concentration of uric acid in the blood and urine, redness of the urine, which disappears within 48 hours, cystitis.

    From the gastrointestinal tract: mucositis, diarrhea, ulcerative lesion stomach and duodenum, nausea, vomiting, esophagitis or stomatitis (appear 3-7 days after application of the drug), oropharyngeal candidiasis, anorexia.

    On the part of the reproductive system: gonad suppression.

    Other: hypersensitivity, carcinogenicity.

    Overdose:

    Heart failure, tachycardia, bone marrow depression, gastritis, gastrointestinal bleeding, hyperthermia, mucositis, multiple organ failure.

    Treatment is symptomatic.

    Interaction:

    With simultaneous administration with drugs that have a pronounced myelotoxic effect - increased toxic effects.

    When taken concomitantly with methotrexate - an increased risk of hepatotoxicity.

    At simultaneous admission with cyclophosphamide or doxorubicin - the risk of cardiotoxicity.

    With simultaneous reception with uricosuric drugs - the risk of developing nephropathy.

    Reduces the antifungal efficacy of allopurinol, colchicine and sulfinpyrazone.

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

    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).

    Special instructions:

    During treatment, it is necessary to monitor hemoglobin, hematocrit, and other blood parameters, including hepatic transaminases, creatinine, bilirubin. It is also necessary to monitor chest X-ray, ECG.

    The use of daunorubicin should be performed by qualified medical personnel in compliance with established precautions when preparing and diluting injection solutions (in a sterile box using disposable surgical gloves and masks), destroying needles, syringes, vials, ampoules and the remainder of the unused preparation.

    In case of accidental ingress of powder or solution onto the skin or mucous membranes, they must be thoroughly rinsed with soap and water.

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