Oncotron® [Mitoxantrone]

Mitoxantrone is 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 IV slowly, for at least 5 minutes or IV drip for 15-30 minutes. It is preferable to introduce Oncotron into the tube of the infusion system with a slow background of a fast infusion of 0.9% sodium chloride solution or 5% glucose solution.

Intrathecal, intraarterial, IM, s / c drug administration is prohibited

The maximum total dose of Onkotron - 200 mg / m² body surfaces.

With breast cancer, non-Hodgkin lymphoma, liver cancer and ovarian cancer Oncotron monotherapy is used at a dose of 14 mg / m² 1 time in 3 weeks. In patients who have previously received chemotherapy, as well as when combined with other anticancer agents, the dose of the drug is reduced to 10-12 mg / m². With repeated courses, the dose of Oncotron is selected taking into account the severity and duration of inhibition of bone marrow hematopoiesis.

In the case of a decrease in the number of neutrophils in previous courses of <1500 and="" or="" platelets="" of="" 50="" 000="" cells="" mcl="" blood="" the="" dose="" oncotron="" is="" reduced="" by="" 2="" mg="" m="" sup="">2 with a decrease in the number of neutrophils <1000 and="" or="" platelets="" 25="" 000="" cells="" l="" of="" blood="" subsequent="" doses="" oncotron="" are="" reduced="" by="" 4="" mg="" m2="" p="">

With treatment of acute non-lymphoblastic leukemia in adults for induction of remission, Oncotron is prescribed in a dose of 10-12 mg / m² daily for 5 days to a total dose of 50-60 mg / m². High doses of Oncotron 14 mg / m are possible.² and more daily for 3 days.

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

With intrapleural installation, with metastases in the pleura (in breast cancer and non-Hodgkin lymphomas) The recommended single dose is 20-30 mg.

For intrapleural installation Oncotron diluted in 50 ml of 0.9% sodium chloride solution. As far as possible, pleural exudate is evacuated before starting therapy. Oncotron, diluted in 50 ml of 0.9% sodium chloride solution, is warmed to body temperature and injected slowly over 5–10 minutes without application of force. The delay period of the first dose of Oncotron in the pleural cavity is 48 hours. During this period, patients should move to ensure optimal intrapleural distribution of the drug. After the end of the specified time (48 hours), the drainage of the pleural cavity is repeated. If the amount of effusion is less than 200 ml, the 1st treatment cycle is terminated. When the amount of effusion exceeding 200 ml, 30 mg of Oncotron is prescribed to be re-installed. Before re-installation of the drug is necessary to control hematological parameters. 2nd dose Oncotron may remain in the pleural cavity. The maximum dose for the 1st treatment cycle is 60 mg. If the number of neutrophils and platelets is within the normal range, the intrapleural installation can be repeated after 4 weeks. For 4 weeks before and 4 weeks after intrapleural administration of Oncotron, systemic treatment with cytostatic drugs should be avoided.

Contraindicated in pregnancy and lactation.

Mitoxantrone treatment 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 pattern 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.

Since in 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 disintegration 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 collection 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 other mechanisms that require high concentration of attention

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.

Symptoms: strengthening, first of all, myelotoxicity and the side effects listed above.

Treatment: 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.