Universal reference book for medicines
Product name: ONCOTRONE (ONCOTRONE)

Active substance: mitoxantrone

Type: Antitumor preparation

Manufacturer: BAXTER ONCOLOGY (Germany)
Composition, form of production and packaging
Concentrate for the preparation of a solution for IV and intrapleural administration of a
dark blue color.

1 ml

mitoxantrone hydrochloride 2.328 mg,

which corresponds to the content of mitoxantrone 2 mg

Excipients: sodium chloride, sodium acetate, acetic acid, ice, water d / u.

5 ml - bottles of colorless glass (1) - packs of cardboard.

12.5 ml - bottles of colorless glass (1) - packs of cardboard.

15 ml - bottles of colorless glass (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Oncotron is a cytostatic drug, a synthetic derivative of anthracenedione.
The mechanism of the antitumor effect has not been completely clarified, however, preliminary data indicate that the drug, being embedded between the bases of the DNA molecule, blocks the processes of replication and transcription. In addition, mitoxanthra inhibits topoisomerase II, has a nonspecific effect on the cell cycle.
PHARMACOKINETICS

After iv introduction mitoksantron quickly penetrates and is distributed in tissues, whence its gradual release occurs.
It 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. Does not penetrate the BBB.
Binding to plasma proteins - 90%.
Metabolised in the liver. Within 5 days, 13.6-24.8% are excreted from the body with bile and in the urine from 5.2% to 7.9% of the drug. The terminal T 1/2 reaches 9 days.
In patients with impaired liver function, there was a decrease in the rate of elimination of the drug.

INDICATIONS

acute non-lymphoblastic leukemia in adults;

- mammary cancer;

- malignant non-Hodgkin's lymphomas;

- primary hepatocellular carcinoma;

ovarian cancer;

- hormone-resistant prostate cancer with pain syndrome.

DOSING MODE

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

The drug is administered iv slowly, for at least 5 minutes or iv in a drip for 15-30 minutes.
It is preferable to introduce Oncotron into the tube of the infusion system slowly against the background of rapid infusion with 0.9% sodium chloride solution or 5% glucose solution.
Intrathecal, intraarterial, in / m, p / c administration of the drug is prohibited

The maximum total dose of Oncotron is 200 mg / m 2 of the body surface.

In breast cancer, non-Hodgkin's lymphoma, liver cancer and ovarian cancer in monotherapy, Oncotron is used at a dose of 14 mg / m 2 once in 3 weeks.
In patients who previously received chemotherapy, as well as when combined with other antitumour agents, the dose of the drug is reduced to 10-12 mg / m 2 . When repeated courses of Oncotron dose are 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 at previous courses of <1500 and / or platelets of 50,000 cells / μl of blood, the Oncotron dose decreases by 2 mg / m 2 with a decrease in the number of neutrophils <1000 and / or platelets <25,000 cells / μL of blood, subsequent Oncotron doses decrease at 4 mg / m 2 .

In the treatment of acute non-lymphoblastic leukemia in adults, in order to induce remission, the Oncotron is administered at a dose of 10-12 mg / m 2 daily for 5 days to a total dose of 50-60 mg / m 2 .
It is possible to use high doses of Oncotron 14 mg / m 2 and more daily for 3 days.
For the treatment of hormone-resistant prostate cancer, Oncotron is prescribed in a dose of 12-14 mg / m 2 once every 21 days in combination with daily intake of low doses of glucocorticosteroids (prednisolone) 10 mg / day or hydrocortisone 40 mg / day).

With intrapleural installation, with pleural metastases (for breast cancer and non-Hodgkin's lymphomas), the recommended single dose is 20-30 mg.

For intrapleural installation Oncotron is diluted in 50 ml of 0.9% sodium chloride solution.
Before the beginning of therapy evacuate, whenever possible, pleural exudate. Oncotron diluted in 50 ml of a 0.9% solution of sodium chloride, warmed to body temperature and injected slowly for 5-10 minutes, without the use of effort.The delay period of the first dose of the 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 this time (48 h), the pleural cavity is re-drained. If the amount of effusion is less than 200 ml, then the first cycle of treatment is stopped. If the amount of effusion is more than 200 ml, a re-installation of 30 mg of Oncotron is prescribed. Before re-installation of the drug, hematological parameters should be monitored. The 2nd dose of Oncotron may remain in the pleural cavity. The maximum dose for the first cycle of treatment is 60 mg. If the number of neutrophils and platelets is within normal limits, intrapleural installation can be repeated after 4 weeks. For 4 weeks before and 4 weeks after intrapleural administration of Oncotron, systemic cytotoxic therapy should be avoided.
SIDE EFFECT

On the part of the hematopoiesis system: leukopenia (usually on day 6-15, recovery on day 21), neutropenia.
thrombocytopenia, erythrocytopenia; rarely - anemia.
On the part of the digestive system: nausea, vomiting, anorexia, decreased appetite, diarrhea, abdominal pain , constipation, gastrointestinal bleeding, stomatitis;
rarely - increased activity of hepatic transaminases, a violation of liver function.
From the cardiovascular system: changes in the ECG, tachycardia, arrhythmia, myocardial ischemia, lowering the fraction of the left ventricle ejection, congestive heart failure.
Toxic myocardial damage, in particular congestive heart failure, 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 / m 2 .
On the part of the respiratory system: cases of interstitial pneumonitis are described.

Allergic reactions: itchy skin.
rash, urticaria, dyspnea, decreased blood pressure, anaphylactic reactions (including anaphylactic shock).
Local reactions: phlebitis, with estravization - erythema, edema, 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: alopecia, increased fatigue, general weakness, fever, nonspecific neurological symptoms, back pain, headache, menstrual disorder, amenorrhea;
rarely - blue coloring of the skin and nails; very rarely - nail dystrophy and reversible blue staining of sclera, secondary infections, hyperuricemia, hypercreatininaemia.
CONTRAINDICATIONS

- the neutrophil count is less than 1500 / μl (excluding the treatment of non-lymphoblastic leukemia);

- lactation period;

- Pregnancy;

- hypersensitivity to mitoxantrone or any other constituents of the drug.

With caution use Oncotron in patients with heart disease, with prior exposure to the mediastinum, with oppression of hematopoiesis, with marked impaired liver or kidney function, with bronchial asthma, with acute viral infectious diseases (including chicken pox, shingles), fungal or bacterial nature (the risk of severe complications and generalization of the process), with diseases in which there is an increased risk of hyperuricemia (gout or urate nephrolithiasis) and in patients previously
oluchavshih anthracyclines.
PREGNANCY AND LACTATION

Contraindicated in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Caution is used oncotron in patients with severe renal dysfunction.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With care use Oncotron in patients with severe violations of the liver.

SPECIAL INSTRUCTIONS

Treatment with mitoxantrone should be performed under the supervision of a doctor who has experience with antitumor drugs.

In the course of treatment, a systematic control of the peripheral blood pattern is necessary (before each introduction, a complete blood count including platelet counting is mandatory), laboratory parameters of liver function, and heart activity (ECG, Echocardiography with determination of the left ventricular ejection fraction (LVEF)).
After achieving a total dose of mitoxantrone of 100 mg / m 2, the determination of LVEF values ​​should be made before each next injection of the drug.
Cardiovascular diseases in the active or inactive phase, mediastinal / pericardial radiation therapy, previous or concomitant with mitoxantrone treatment, previous treatment with other anthracyclines or anthracenedions, and concomitant treatment with other cardiotoxic drugs may increase the risk of toxic cardiac damage.
The risk of cardiotoxicity rises when the total dose of mitoxantrone exceeds 140 mg / m 2 , however, toxic heart damage can develop at lower total doses of the drug.
Because
in some patients with acute leukemia can develop severe stomatitis, 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, hypouricemic drugs should be prescribed.
In the case of extravasation, it is necessary to stop the administration of the drug and, if necessary, continue the infusion into another vein.

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 or myelodysplastic syndrome.

Due to the immunosuppressive effect of the drug and the possibility of developing severe infections, it is not recommended to apply live vaccines during chemotherapy.
Vaccination should be carried out 3 months after the completion of therapy.
Women and men during treatment with mitoxantrone, and also within 6 months after withdrawal, should use reliable methods of contraception.

Avoid contact with the skin or mucous membranes;
possibly the emergence of tissue necrosis. The skin, in case of contact with the drug, must be thoroughly rinsed with warm water.
If necessary, the undiluted Oncotron solution (with aseptic fetal removal from the vial) can be used in parts for 7 days if stored at a temperature of no higher than 25 ° C.

After dilution, Oncotron solution should be used within 4 days (aseptic conditions of sampling, storage at 4-25 ° C), after 96 hours unused preparation should not be used.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: Increased, in the first place, myelotoxicity and the above-mentioned side effects.

Treatment: 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 unknown.
DRUG INTERACTION

Pharmaceutical interaction

Do not mix the drug with other agents with iv introduction (precipitation may occur);

Pharmacodynamic interaction

Oncotron potentiates the action of many cytotoxic drugs, such as cytarabine, cisplatin, cyclophosphamide, 5-fluorouracil, methotrexate, vincristine, dacarbazine.

With the simultaneous use of Oncotron with other antitumour agents or irradiation of the mediastinum region, it is possible to increase its cardio- and myelotoxicity.

Simultaneous administration of drugs that block tubular secretion (including uricosuric anti-hyperglycemic drugs - sulfinpyrazone), may increase the risk of developing nephropathy.

Pharmacokinetic interaction

There were no dangerous interactions with other drugs.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List A. The drug should be stored out of the reach of children at a temperature of no higher than 25 ° C.
Do not freeze. Shelf life - 3 years.
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