Oncotron injection of 2 mg ml 10 ml N1
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Active ingredients
Mitoxantrone
Release form
Solution
Composition
In one vial, Endoxan 1000 mg contains: active ingredient: cyclophosphamide monohydrate 1069.0 mg equivalent to anhydrous cyclophosphamide 1000.0 mg; excipients: no.
Pharmacological effect
Oncotron is a cytostatic drug, a synthetic derivative of anthracene. The mechanism of the antitumor action is not completely elucidated, however, preliminary data indicate that the drug, embedded between the bases of the DNA molecule, blocks replication and transcription. In addition, mitoxantror inhibits topoisomerase II, has a nonspecific effect on the cell cycle.
Pharmacokinetics
After iv administration, mitoxantrone rapidly penetrates and is distributed in the tissues, from where it is then gradually released. It is found in high concentrations in the liver, lungs and in decreasing order: in the bone marrow, heart, thyroid, spleen, pancreas, adrenal glands and kidneys. Does not penetrate the BBB. Plasma protein binding - 90%. Metabolized in the liver. Within 5 days, 13.6-24.8% is excreted in the bile and in urine from 5.2% to 7.9% of the preparation. Terminal T1 / 2 reaches 9 days. In patients with impaired liver function, a decrease in the rate of elimination of the drug was observed.
Indications
- Acute non-lymphoblastic leukemia in adults; - mammary cancer; - Malignant non-Hodgkin lymphomas; - primary hepatocellular carcinoma; - ovarian cancer; - hormone-resistant prostate cancer with pain syndrome
Contraindications
- Hypersensitivity to mitoxantrone or any other component of the drug; - neutrophil count less than 1500 / μl (except for the treatment of non-lymphoblastic leukemia); - pregnancy and lactation period.
Precautionary measures
Oncotron is used in patients with heart disease, with prior irradiation of the mediastinum, with hematopoietic suppression, with marked impaired liver or kidney function, with bronchial asthma, and acute viral infectious diseases (including chicken pox, shingles), fungal or bacterial nature (the risk of severe complications and generalization of the process), with diseases where there is an increased risk of developing hyperuricemia (gout or urate nephrolithiasis) and in patients who have previously received anthrax cyclins.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Dosage and administration
Mitoxantrone is a part of many chemotherapy regimens, and therefore, when choosing the route of administration, regimen and doses in each individual case, you should be guided by the data of special literature. The drug is administered intravenously slowly for at least 5 minutes or intravenously over 15-30 minutes. It is preferable to introduce Oncotron into the tube of the infusion system slowly against the background of a quick infusion of 0.9% sodium chloride solution or 5% glucose solution. Intrathecal, intraarterial, intramuscular, subcutaneous injection of the drug is prohibited! The maximum total dose of Oncotron is 200 mg / m2 of body surface.
Side effects
From the side of the hemopoietic system: leukopenia (usually for 6-15 days, recovery for 21 days), neutropenia. thrombocytopenia, erythrocytopenia; rarely - anemia. On the part of the digestive system: nausea, vomiting, anorexia, loss of appetite, diarrhea, abdominal pain, constipation, gastrointestinal bleeding, stomatitis; rarely - increased activity of liver transaminases, impaired liver function. Since the cardiovascular system: changes in the ECG, tachycardia, arrhythmias, myocardial ischemia, reduced left ventricular ejection fraction, congestive heart failure. Toxic damage to the myocardium, in particular congestive heart failure, can develop both during treatment with mitoxantrone and after months and years after the end of therapy. The risk of a cardiotoxic effect increases when a total dose of 140 mg / m2 is reached. On the part of the respiratory system: cases of interstitial pneumonitis are described. Allergic reactions: pruritus. rash, urticaria, shortness of breath, decrease in blood pressure, anaphylactic reactions (including anaphylactic shock). Local reactions: phlebitis, with estravation - erythema, swelling, pain, burning, necrosis of surrounding tissues. Cases of intense blue staining of the veins into which the drug was injected and the surrounding tissues were described. Other: alopecia, fatigue, general weakness, fever, non-specific neurological symptoms, back pain, headache, menstrual disorders, amenorrhea; rarely blue staining of skin and nails; very rarely - nail dystrophy and reversible blue sclera staining, secondary infections, hyperuricemia, hypercreatininemia.
Overdose
Symptoms: increased, first of all, myelotoxicity and the side effects listed above. Treatment: the use of dialysis is not effective.In case of overdose, close monitoring of the patient should be established and, if necessary, symptomatic therapy should be carried out. The specific antidote for mitoxantrone is unknown.
Interaction with other drugs
Pharmaceutical interaction Do not mix the drug with other means with a / in the introduction (precipitation may occur); Pharmacodynamic interaction Oncotron potentiates the action of many cytotoxic drugs such as cytarabine, cisplantin, cyclophosphamide, 5-fluorouracil, methotrexate, vincristine, dacarbazine. With the simultaneous use of Oncotron with other antitumor agents or irradiation of the mediastinal area, it is possible to increase its cardio and myelotoxicity. The simultaneous appointment of drugs that block tubular secretion (including uricosuric anti-dandruff drugs - sulfinpyrazon) may increase the risk of developing nephropathy. Pharmacokinetic interaction No dangerous interactions with other drugs were detected.
special instructions
Treatment with mitoxantrone should be carried out under the supervision of a physician with experience in working with anticancer drugs. In the course of treatment, systematic monitoring of the peripheral blood picture is required (before each injection a complete blood count is required, including platelet counts), laboratory parameters of liver function, and heart activity (ECG, EchoCG with determination of left ventricular ejection fraction (LVEF)). After reaching the total dose of 100 mg / m2 mitoxantrone, the determination of LVEF should be carried out before each next injection of the drug. Cardiovascular diseases in the active or inactive phase, radiotherapy to the mediastinum / pericardial region, conducted previously or carried out simultaneously with mitoxantrone treatment, prior treatment with other anthracyclines or anthracendions, as well as concomitant treatment with other cardiotoxic drugs can increase the risk of toxic heart damage. The risk of cardiotoxicity increases when exceeding the total dose of mitoxantrone at 140 mg / m2, however, toxic damage to the heart can develop at lower total doses of the drug. Sincein some patients with acute leukemia, severe stomatitis may develop, it is recommended to carry out preventive measures. In the treatment of leukemia, hyperuricemia may occur as a result of the rapid breakdown of tumor cells. If necessary, you should prescribe hypouricemic drugs. In case of extravasation, it is necessary to stop the administration of the drug and, if necessary, to continue the infusion into another vein. The use of topoisomerase II inhibitors, including mitoxantrone, in combination with other anticancer drugs and / or radiotherapy may lead to the development of acute myeloblastic leukemia or myelodysplastic syndrome. Due to the immunosuppressive effect of the drug and the possibility of developing serious infections, it is not recommended to use live vaccines during chemotherapy. Vaccination should be carried out 3 months after completion of therapy. Women and men during treatment with mitoxantrone, as well as within 6 months after its cancellation, should use reliable methods of contraception. Avoid contact with the skin or mucous membranes, because possible necrosis of tissues. In case of contact with the preparation, the skin should be thoroughly rinsed with warm water. If necessary, the undiluted solution of Oncotron (with aseptic intake of the drug from the vial) can be used in parts for 7 days if it is stored at a temperature not higher than 25 ° C. After dilution, the Oncotron solution should be used for 4 days (aseptic conditions of the intake, storage at 4–25 ° C), after 96 hours, the unused preparation should not be used. Impact on the ability to drive vehicles and control mechanisms During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.