Active substanceMitoxantroneMitoxantrone
Similar drugsTo uncover
  • Mitoxantrone
    concentrate in / in c / cavity 
    VALEANT, LLC     Russia
  • MITOXANTRON
    concentrate in / in 
    FARM STANDART, OJSC     Russia
  • Mitoxantrone-LENS®
    concentrate d / infusion 
    VEROPHARM SA     Russia
  • Oncotron
    concentrate in / in c / cavity 
  • Dosage form: & nbsptooncentrate for solution for infusion
    Composition:

    1 ml of concentrate contains:

    active substance: mitoxantrone hydrochloride in terms of mitoxantrone 2.00 mg;

    Excipients: acetic acid 0.46 mg, sodium acetate 0.05 mg, sodium chloride 8.00 mg, water for injection up to 1 ml.

    Description:

    The liquid is dark blue.

    Pharmacotherapeutic group:Antitumor agent - antimetabolite
    ATX: & nbsp

    L.01.D.B.07   Mitoxantrone

    L.01.D.B   Anthracyclines and related drugs

    Pharmacodynamics:

    Mitoxantrone is a synthetic derivative of anthracenedione. The mechanism of the antitumor effect is not fully understood. The drug is inserted between the bases of the DNA molecule, blocking the processes of replication and transcription, in addition mitoxantrone inhibits topoisomerase II. Has a nonspecific effect on the cell cycle.

    Pharmacokinetics:

    The drug quickly penetrates into tissues after intravenous administration.78% of mitoxantrone binds to plasma proteins. Mitoxantrone is found in high concentrations in the liver, lungs and in descending order in the bone marrow, heart, thyroid gland, spleen, pancreas, adrenal gland and kidney.

    Biotransformatsya in the liver. It is excreted with bile (about 25%) and kidneys (6-11%, of which 65% unchanged). Most of the dose is actively captured and bound in tissues, from which it is gradually released. The half-life period averages 75 hours (from 23 to 215 hours).

    Does not penetrate the blood-brain barrier.

    Indications:

    - Acute non-lymphoblastic leukemia in adults.

    - Common breast cancer.

    - Malignant lymphomas.

    - Primary hepatocellular carcinoma.

    - Hormonal-resistant prostate cancer with pain syndrome.

    - Ovarian cancer.
    Contraindications:

    - Hypersensitivity to mitoxantrone or any other compound parts of the drug.

    - The neutrophil count is less than 1500 / μl (excluding treatment non-lymphoblastic leukemia).

    - Pregnancy and lactation.

    Carefully:With cautionMitoxantrone-LENS® is used in patients with heart disease, with previous mediastinal radiation, with oppression of hematopoiesis,expressed violations of the liver or kidney function, with bronchial asthma.

    Dosing and Administration:

    Intravenously slowly for 3-5 minutes or intravenously drip for 15-30 minutes.

    Intrathecal administration of the drug is prohibited!

    Mitoxantrone is a part of many chemotherapy regimens, therefore, when choosing the regimen and doses in each individual case, one should be guided by the literature data.

    With monotherapy for breast cancer, non-Hodgkin's lymphomas and liver cancer the recommended dose is 14 mg / m2 body surface 1 every 3 weeks. In patients who previously received chemotherapy, as well as when combined with other chemotherapeutic agents, the dose is reduced to 10-12 mg / m2. With repeated courses, the dose of mitoxantrone is selected taking into account the degree of severity and duration of oppression of bone marrow hematopoiesis. In the case of a decrease in the number of neutrophils <1500 / μl and / or platelets <50000 / μl in previous courses, the dose of mitoxantrone is reduced by 2 mg / m2, with a decrease in the number of neutrophils <1000 / μL and / or platelets <25,000 / μL of blood, subsequent doses are reduced by 4 mg / m2.

    When treating acute non-lymphoblastic leukemia in adults for induction of remission mitoxantrone prescribe in a dose of 10-12 mg / m2 daily for 2-3 days in combination with cytarabine. A detailed description of the regimens of combined chemotherapy is presented in the literature. It is possible to use high doses of mitoxantrone 14 mg / m2 and more daily for 3 days.

    For treatment of hormone-resistant prostate cancer mitoxantrone prescribe in a dose of 12-14 mg / m2 1 every 21 days in combination with daily intake of low doses of glucocorticosteroids (prednisolone 10 mg / day or hydrocortisone 40 mg / day).

    The maximum total dose Mitoxantrone-LENS® with intravenous administration - 200 mg / m2.

    With metastatic pleural lesions mitoxantrone can be administered intrapleural, with the recommended dose being 20-30 mg. Before beginning instillation should, if possible, pleural exudate. The time of finding the drug in the pleural cavity is 48 hours, during which the patient should move as much as possible to ensure optimal intrapleural distribution of the drug. After 48 hours, the pleural cavity is re-drained, in order to remove the possible effusion. If the amount of effusion is less than 200 ml, the first treatment cycle is stopped.With an effusion volume exceeding 200 ml, a repeated instillation of 30 mg of Mitoxantrone-LENS® is prescribed. Before carrying out the repeated instillation of the drug, hematological parameters should be monitored. After carrying out the repeated instillation, it is necessary to remove mitoxantrone from a pleural cavity is not present. The maximum dose for one treatment cycle is 60 mg of Mitoxantrone-LENS®. With normal leukocyte and platelet counts, intrapleural instillation of mitoxantrone (2nd cycle) can be repeated after 4 weeks.

    For 4 weeks before and 4 weeks after intrapleural administration of Mitoxantrone-LENS®, systemic therapy with cytostatic agents should be avoided.

    Instructions for preparing a solution for intravenous and intrapleural administration

    Before use, the Mitoxantrone-LENS® vial should be visually assessed for sediment and discoloration.

    Immediately before intravenous administration, the required amount of concentrate is diluted in at least 50 ml of a 0.9% solution of sodium chloride or a 5% solution of dextrose. For intrapleural administration, the mitoxantrone concentrate is diluted in a 0.9% solution of sodium chloride untilconcentration of 2 mg / 1 ml.

    Diluted solution should be used immediately after preparation.

    Side effects:

    On the part of the hematopoiesis system: leukopenia, neutropenia, thrombocytopenia, rarely anemia.

    From the digestive system: nausea, vomiting, diarrhea, stomatitis, abdominal pain, constipation, anorexia; in some cases - transient liver dysfunction.

    From the side of the cardiovascular system: rhythm disturbances, chest pain, myocardial ischemia, lowering of left ventricular ejection fraction, congestive cardiovascular failure. Toxic myocardial damage, in particular congestive heart failure (CHF), can develop both during treatment with mitoxantrone, and in months and years after the end of therapy. The risk of a cardiotoxic effect increases when the total dose is 140 mg / m2.

    On the part of the respiratory system: cases of interstitial pneumonitis are described.

    Allergic reactions: there are rare reports of arterial hypotension, urticaria, dyspnea and rash, anaphylactic reactions, including anaphylactic shock.

    Local Reactions: phlebitis; when extravasation - erythema, swelling, pain, burning, necrosis of surrounding tissues. Cases of intense blue staining of veins, into which the preparation was administered and surrounding tissues, are described.

    Other: disorders of the menstrual cycle, amenorrhea, transient alopecia, fever, increased fatigue, general weakness, fever, nonspecific neurological symptoms; in some cases - a violation of kidney function. Against the background of the use of mitoxantrone in the first 2 days, transient blue-greenish staining of the urine, sometimes a sclera, as well as nails and their separation from the nail bed, is possible. In connection with the immunosuppressive effect of the drug, the development of secondary infections is possible.

    Overdose:

    In case of overdose, it is possible to intensify primarily myelotoxicity and the above-mentioned side effects. The use of dialysis is not effective. In case of overdose, careful monitoring of the patient should be made and, if necessary, symptomatic therapy should be performed. The specific antidote for mitoxantrone is not known.

    Interaction:

    With the simultaneous use of Mitoxantrone-LENS® with other antitumour agents, it is possible to increase its cardio- and myelotoxicity.

    The drug should not be mixed with other drugs in one syringe or vial, as this can cause precipitation.

    It is not recommended simultaneous administration of drugs from the group of non-steroidal anti-inflammatory drugs.

    Special instructions:

    Treatment with mitoxantrone should be performed under the supervision of a physician with experience in the use of cytotoxic agents.

    In the process of treatment, a systematic control of the peripheral blood picture is necessary (before each introduction, a complete blood test, including platelet counting), laboratory parameters of liver function, and heart activity (ECG, EchoCG with determination of left ventricular ejection fraction (LVEF). dose of mitoxantrone in 100 mg / m2 determination of LVEF values ​​should be made before each next injection. Cardiovascular diseases in the active or inactive phase, radiotherapy in the mediastinal region / pericardial region, previously performed or conducted simultaneously with the treatment of mitoxantrone, previous treatment with other anthracyclines or anthracenedions,as well as concomitant treatment with other cardiotoxic drugs may increase the risk of toxic cardiac damage.

    The risk of cardiotoxicity increases when the total dose of mitoxantrone exceeds 140 mg / m2, however, toxic heart damage can develop at lower total doses of the drug.

    Since some patients with acute leukemia can develop severe stomatitis, it is recommended to take preventive measures.

    In the treatment of leukemia, hyperuricemia may occur as a result of rapid disintegration of tumor cells. If necessary, hypouricemic drugs should be prescribed.

    The use of topoisomerase II inhibitors, including mitoxantrone, in combination with other antitumor drugs and / or X-ray therapy, can lead to the development of acute myeloblastic leukemia (AML) or myelodysplastic syndrome (MDS).

    In connection with the immunosuppressive effect of the drug and the possibility of developing a serious infection, it is not recommended to use live vaccines during chemotherapy. Vaccination should be carried out 3 months after the completion of therapy.

    Do not recommend applying mitoxantrone in patients with chickenpox (incl.recently transferred or after contact with the diseased), herpes zoster and other acute infectious diseases.

    In the case of extravasation, it is necessary to stop the administration of the drug and, if necessary, continue the infusion into another vein.

    Women and men during treatment with mitoxantrone, and also within 3 months after its withdrawal should use reliable methods of contraception.

    Avoid contact with the skin or mucous membranes; possibly the emergence of tissue necrosis. Skin and mucous membranes, in case of accidental contact with the drug, should be thoroughly washed with warm water.
    Form release / dosage:

    Concentrate for the preparation of a solution for infusion, 2 mg / ml (10 mg / 5 ml, 20 mg / 10 ml, 25 mg / 12.5 ml or 30 mg / 15 ml).

    Packaging:

    For 5 ml, 10 ml, 12.5 ml or 15 ml in vials of colorless or lightproof glass, hermetically sealed with stoppers rubber bromobutyl or Chlorobutyl with a capping of caps by aluminum or aluminum-plastic.

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

    For 35, 50, 85 bottles with an equal number of instructions for use in a box of cardboard (for hospitals).

    Storage conditions:

    In the dark place at a temperature of 10 to 20 ° 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:P N000458 / 01
    Date of registration:14.03.2012 / 04.08.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Representation: & nbspVEROPHARM, AO VEROPHARM, AO Russia
    Information update date: & nbsp09.06.2018
    Illustrated instructions
      Instructions
      Up