MYTOKSANTRON

Active material: Mytoksantron
When ATH: L01DB07
CCF: Anticancer drug
When CSF: 22.04.04
Manufacturer: PHARMACEUTICAL WORKS JELFA S.A. (Poland)

Pharmaceutical form, composition and packaging

Solution Injectable1 ml1 fl.
mytoksantron2 mg20 mg

10 ml – vials of dark glass (1) – packs cardboard.

 

Pharmacological action

The antitumor agent, antimetaʙolit (from the group synthetic anthracyclines). The mechanism of action is associated with inhibition of the synthesis of RNA and DNA, inhibition of mitosis (It acts as proliferating, and in non-proliferating cells). The most active in the later stage of the S-phase, but is not a drug fazospetsifichnym. It shows no cross-resistance to most cytotoxic drugs. In addition to the monotherapy, It can be used in combination with other. cytostatics. In vitro inhibits proliferation of T- and B-lymphocytes, macrophages, violates the process of antigen presentation, as well as the secretion of interferon gamma, TNF-alpha, interleykina2. Myelosuppressive effects as much as possible is manifested through 10 days after administration, Regeneration occurs in approximately 21 day.

 

Testimony

Mammary cancer (local and / or distant metastases), nehodzhkinskaya lymphoma, Acute leukemia myeloblastnыy, Acute leukemia promyelotsytarnыy, Acute leukemia эrytroydnыy, liver cancer, hormone-refractory prostate cancer, rakovyi ascites, multiple sclerosis (secondary-progressive, remittiruyusche-progressive, remitting rapidly deteriorating).

 

Contraindications

Hypersensitivity, pregnancy, lactation. The acute phase of myocardial infarction, decompensated chronic heart failure, tachysystolic form of arrhythmia, severe angina; acute infectious viral disease, fungal or bacterial origin (incl. enable vetryanaya, shingles); hepatic failure, CRF, hyperuricemia (gout especially manifested or urate nefrourolitiazom); suppression of bone marrow hematopoiesis (leukopenia, pancytopenia, incl. with concurrent radiation or chemotherapy).

 

Side effects

From the side of hematopoiesis: inhibition of hematopoiesis – leukopenia, neutropenia, thrombocytopenia, rarely – anemia, erythropenia. From the digestive system: nausea, vomiting, decreased appetite, diarrhea, abdominal pain, constipation, bleeding from the gastrointestinal tract, stomatitis, rarely – activity increase “Hepatic” transaminases, abnormal liver function. From the CCC: ECG changes, tachycardia, Arrhythmia, myocardial ischemia, decrease CRM, development or exacerbation of heart failure. Allergic reactions: itching, rash, hives, decrease in blood pressure, breathlessness, anaphylactic reactions (incl. anaphylactic shock). Other: interstitial pneumonitis (edenichnыe cases), hair loss, fatigue, weakness, nonspecific neurological symptoms, backache, headache, hyperthermia, breathlessness, increasing concentrations of urea, giperkreatininemiя, menstrual disorders, amenorrhea, rarely – blue coloring of the skin and nails, rarely – nail dystrophy and reversible blue coloring of the sclera, secondary infections, hyperuricemia. Local reactions: erythematous rash, edema, pain, burning of the skin, skin necrosis (when extravasation), blue skin at the injection site, flebit.Peredozirovka. Symptoms: It is seen rapid development and greater severity of side effects. Treatment: symptomatic, Hemodialysis and peritoneal dialysis are ineffective.

 

Dosing and Administration

In / jet, slowly (during 10 m) or drip (during 30 m). For intraperitoneal administration of diluted 2 l water. To prepare the solution for the on / in the dissolved in 50-100 ml 0.9% NaCl solution, or 5% dextrose. The dosage and intervals between injections are determined depending on the degree of myelosuppression. Summary course dose should not exceed 200 mg / square meter of body surface. Monotherapy with advanced breast cancer and non-Hodgkin's lymphoma – / drip, dose 14 mg / square meter of body surface, during 30-40 m, 1 once every 3-4 Sun. If repeated courses dose is adjusted depending on the severity of myelosuppression: at least neutropenia 1.5 th. / l and / or thrombocytopenia less 50 th. / ml dose in previous courses is reduced by 2 mg / m; at least neutropenia 1 th. / l and / or thrombocytopenia less 25 thous. / l lower for subsequent doses 4 mg / m. In the combination therapy of breast cancer and non-Hodgkin's lymphoma is used for the initial dose 2-4 mg / m less than the, which is recommended as monotherapy. Subsequent dosage will depend on the degree and duration of myelosuppression. In the treatment of acute leukemia, for the induction of remission and consolidation therapy – 10-12 mg / m daily for 2-3 days in combination with cytarabine. Possible to use a dose of 14 mg / m or more. Hormone-refractory prostate cancer – 12-14 mg / m 1 once every 21 day in combination with glucocorticosteroids. Multiple sclerosis: 12 mg / m in / jet slowly, once every 3 Months.

 

Cautions

It is unacceptable n / a, / m and intrathecal. After contact with the skin or mucous membranes should be thoroughly rinsed with warm water. Women and men of reproductive age should use reliable methods of contraception during treatment and during 6 months after the end. In applying the drug may stain urine blue-green color (through 1-2 days after injection). During treatment it is necessary to control the clinical condition of patients, hematological (before each administration) and biochemical parameters of liver function, control of the CAS (ECG, Echocardiogram with the definition of LV ejection fraction). The risk of cardiotoxicity increases with total dose exceeds 140 mg / m, however, it may develop at lower total doses. Leiko- and neutropenia during treatment is usually seen on 6-15 day after administration, and typically recover at 21 d. Mytoksantron, As immunosuppressive, may reduce the immune response to vaccination, if it is carried out simultaneously with the therapy mitoxantrone. Need rejection of immunization in the range of 3 to 12 months after dosing (if it is not recommended by a doctor); others. family members of the patient, residing with him, should abandon immunization oral polio vaccine (Avoid contact with people, receiving the polio vaccine, or wear a protective mask, covering the nose and mouth). Multiple sclerosis patients is recommended to determine the left ventricular ejection fraction (LVEF) before the first drug administration, and before each next administration after a total dose 100 mg / m or more, or with symptoms of heart failure. If the value is less than LVEF 50%, or clinically significant reduction in LVEF, or received a total dose 140 mg / m or more drug treatment is not recommended. In the event of hyperuricemia can assign urikozuricheskih drugs. If extravasation must stop administering the drug and if necessary to continue infusion, etc.. vein.

 

Cooperation

Dr.. anticancer drugs or radiation therapy may increase toxicity (especially with regard to bone marrow and heart). Daunorubicin, doxorubicin or radiation of the mediastinum increase the risk of cardiotoxicity. Co-administration of drugs, block tubular secretion (incl. urikozuricheskih arthrifuge drugs – sulfinpirazon), may increase the risk of developing nephropathy. Pharmaceutical incompatible with heparin, and thiamine.

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