Mytoksantron: instructions for using the medicine, structure, Contraindications
Mytoksantron – Characteristic
Митоксантрона гидрохлорид — синтетическое производное антрациклина.
Mytoksantron – Pharmacological action
Mytoksantron – Application
Mammary cancer (with regional or distant metastases); liver cancer, ovary, prostate (incl. gormonalnoustoychivy stage IV with pain); non-Hodgkin's lymphoma; acute myelogenous, promyelocytic, monoblastnыy leukemia; erythromyelosis adults (the ineffectiveness of traditional means), rakovyi ascites.
Mytoksantron – Contraindications
Hypersensitivity, intrathecal, pregnancy, lactation.
Mytoksantron – Restrictions apply
Assessment of the risk-benefit ratio in the following cases: leukopenia, pancytopenia, Heavy flows comorbidities, liver dysfunction and / or kidney, gout, enable vetryanaya, herpes zoster, prior cytotoxic or radiation therapy, the elderly or children's age.
Mytoksantron – Pregnancy and breast-feeding
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.
Mytoksantron – Side effects
From the nervous system and sensory organs: headache (10%), convulsions (4%), weakness, fatiguability.
Cardio-vascular system and blood (hematopoiesis, hemostasis): heart failure (5%), arrhythmia (3%), tachycardia, chest pain, transient ECG changes, decrease in left ventricular ejection fraction, myocardial infarction, gipotenziya, phlebitis, bleeding, leukopenia, thrombocytopenia, erythropenia.
From the digestive tract: loss of appetite, nausea and vomiting (72%), diarrhea (47%), stomatitis (29%), gastrointestinal bleeding (16%), abdominal pain (15%), jaundice (3%), ulcers in the mouth and on the lips, abnormal liver function (increased levels of bilirubin, change of AST, GOLD), constipation.
For the skin: alopecia (37%), fungal skin lesions (15%), petechiae / ekhimoznye rashes (7%), rash, hives, itch.
From the respiratory system: flu-like symptoms (78%), breathlessness (18%), cough (13%).
With the genitourinary system: hyperuricemia, renal failure, amenorrhea, azoospermia.
Other: развитие инфекций — 66% (incl. сепсис — 34%, грибковые инфекции — 15%, пневмония — 9%, upper respiratory tract infection- 7%), fever, allergic reactions (anaphylaxis and the like.), conjunctivitis (5%), irritation at the injection site, necrosis of subcutaneous fat (in contact with the skin and into the perivascular space).
Mytoksantron – Cooperation
Toxicity increases and other anti-tumor drugs mielotoksicskie, probenecid, sulfinpirazon, radiation therapy. Daunorubicin, doxorubicin, irradiation of the mediastinum increase the risk of cardiotoxicity. Chance nephropathy increase urikozuricheskih protivopodagricakih drugs (dose adjustment is needed in the treatment of hyperuricemia and gout). NSAIDs potentiate the side effects of blood (the risk of bleeding). Weakens the effectiveness of immunization inactivated vaccines; using vaccines, containing live viruses, enhances viral replication and side effects of vaccination (immunosuppressive effect). Pharmaceutical incompatible with thiamine (causing its destruction), heparin and other drugs in the infusion solution or a syringe.
Mytoksantron – Overdose
Symptoms: severe bone marrow depression (for up to 3 Sun), agranulocytosis, necrotic angina, infections of the digestive tract, diarrhea, bleeding, manifestations of cardiotoxicity.
Treatment: hospitalization, monitoring vital functions; dose reduction or withdrawal of the drug; simptomaticheskaya therapy; if necessary - transfusion of blood components, platelet and leukocyte mass, the appointment of broad-spectrum antibiotics.
Mytoksantron – Dosing and Administration
B /, B / A, vnutrybryushynno. The batch is individually. Adults in leukemia to induce remission — в/в инфузионно в дозе 12 mg / m2/day with 1 by 3 день в комбинации с цитарабином — 100 mg / m2/day in the form of continuous 24-hour infusion 1 by 7 day. With little effect may conduct re-induction course: mitoxantrone administered in 1 and 2 day with cytarabine 1 by 5 day the same dose. Для поддержания ремиссии — 12 mg / m2/sut 1 and 2 день в комбинации 100 mg / m2 cytarabine per day, вводимого в/в в течение 24 ч с 1 by 5 Day after about 6 weeks after the induction course (second supporting course is conducted through 4 weeks after the first). When prostate cancer — 12–14 мг/м2 1 once every 3 Sun (in combination with corticosteroids). When breast cancer, liver and non-Hodgkin lymphoma - 14 mg / m2/every day 3 Sun. При комбинированной терапии начальную дозу понижают на 2–4 мг/м2 compared to the monotherapy dose.
Mytoksantron – Precautions
Use only under medical supervision, with experience chemotherapy. Prior to and during treatment (at short intervals) requires constant monitoring of peripheral blood cell, determination of hemoglobin or hematocrit, the number of leukocytes (overall, differential), Platelet, determining the concentration of uric acid, conduct functional studies of the heart, light, liver, kidney. Severe leukopenia observed during 10 days (the number of leukocytes recovered for 3 Sun), mucositis appears within 1 weeks after treatment. If the following symptoms: pancytopenia, chills, fever, cough or hoarseness, pain in the lower back or side, painful or difficult urination, bleeding or hemorrhage, black stools, blood in the urine or feces should immediately consult a doctor. The development of neutropenia necessitates careful monitoring for timely detection of signs of infection. Should defer vaccination schedule (possible not earlier than 3 month and up 1 years after completion of the last cycle of chemotherapy), avoid contact with infectious patients, or use non-event for the prevention of (face mask, etc.). Other family members, staying with the patient, should abandon immunization oral polio vaccine. In the event of thrombocytopenia advised extreme caution when performing invasive procedures, Regular inspection of places on / in the, skin and mucous membranes (for signs of bleeding), control of blood in the urine, vomit, Kale. The patients must be carefully shave, manicure, brush your teeth, dentists use threads and toothpicks, avoid falls and other injuries, drinking alcohol and acetylsalicylic acid, increase the risk of gastrointestinal bleeding. Additional treatment is possible after disappearance gematotoksichnosti effects. При кумулятивных дозах выше 140 mg / m2 or 100 mg / m2 in patients with risk factors (mediastinal irradiation, a history of heart disease, previous treatment with anthracyclines) increased risk of cardiotoxicity. The development of nephropathy, due to increased production of uric acid, It can be prevented by adequate fluid intake, the use of allopurinol or urine alkalinization. Safety and effectiveness in children have not been established, therefore it is necessary to refrain from appointment as a child. During treatment it is necessary to use adequate contraceptive measures. It should warn patients of the potential hazard to the fetus, If during treatment arises pregnancy. In case of contact with skin or mucous membranes must be thorough washing with water (mucosa) or soap and water (skin). If you have extravasates during I / injection or infusion administration should stop and resume in another vein.
Mytoksantron – Cautions
After 1-2 days maybe blue-green coloration of urine, в редких случаях — обратимое голубое окрашивание склер, veins and tissues paravenoznyh, polish (probable detachment of the nail plate). For / in the mitoxantrone hydrochloride concentrate should be pre-diluted 0,9% solution of sodium chloride or 5% dextrose. Dissolution, dilution and administration of the preparation is carried out by trained medical staff with the protection (gloves, masks, clothing and other.).
Mytoksantron – Взаимодействие с другими лекарствами
|Active substance||Description of interaction|
|Allopurinol||FMR. Against the background of mitoxantrone (can increase the concentration of uric acid in the blood, the risk of developing nephropathy) It requires an increased dose.|
|Busulfan||FMR. Strengthens (mutually) toxic manifestations (especially in the lungs).|
|Daunorubicin||FMR. Increases (mutually) the risk of cardiotoxic manifestations.|
|Doxorubicin||FMR. Increases (mutually) the likelihood of side effects, incl. cardiac (heart failure, arrhythmia, infarction and the like.).|
|Thiamin||FV. Pharmaceutical incompatibility.|