Mitomitsin-S Kiova

Mitomitsin-S Kiova – an antineoplastic antibiotic.

Form of release and structure

Dosage form – crystal powder (or crystals) for preparation of solution for injections, blue-violet color (on 2, 10 and 20 mg in bottles from colourless transparent glass; in a cardboard box with cells of 10 bottles (on 2 mg); in a cardboard box of 5 bottles packed into individual cardboard boxes (on 10 and 20 mg)).

Active ingredient: митомицин, in 1 bottle – 2, 10 or 20 mg.

Auxiliary component is sodium chloride.

Indications to use

• Gullet cancer;
• Carcinoma of the stomach;
• Colon cancer and rectum;
• Bile duct carcinoma;
• Liver cancer;
• Pancreatic cancer;
• Cancer of a neck of uterus;
• Vulva cancer;
• Endometrial cancer;
• Breast cancer;
• Mesothelioma;
• Bladder cancer;
• Cancer of a renal pelvis and ureters;
• Prostate cancer;
• Not small-celled cancer of a lung;
• Malignant tumors of a neck and head.

Contraindications

Absolute:

• Heavy renal failures;
• The expressed oppression of function of marrow;
• The raised bleeding or disturbance of coagulability of blood;
• Pregnancy;
• Lactation;
• Hypersensitivity to a mitomitsin.

Relative (it is necessary to observe extra care because of risk of development of complications):

• Children's age;
• Acute infectious diseases of a bacterial, fungal or virus origin.

Route of administration and dosage

Mitomitsin-S Kiov is entered struyno slowly intravenously or vnutripuzyrno (at treatment of tumors of a bladder), if necessary – intraperitoneally, vnutriplevralno or vnutriarterialno. Before introduction powder is dissolved water for injections to concentration of 0,4 mg/ml.

Doses are established by the doctor individually depending on indications, the general condition of the patient and the optimum scheme of antineoplastic therapy.

Usually drug is appointed in the following doses:

• 20 ^mg/sq.m intravenously 1 time each 4-6 weeks;
• 2 ^mg/sq.m intravenously 1 time in 1-5 and 8-12 days each 4-6 weeks;
• 10 ^mg/sq.m intravenously (in combination with other cytostatics) 1 time each 6-8 weeks;
• 30-40 mg, divorced 30-60 ml of sterile aqueous solution (concentration no more than 1 mg/ml), vnutripuzyrno once a week within 6-8 weeks, then – once a month within 6 months.

Due to the probability of a cumulative miyelosupressiya which causes митомицин at the subsequent intravenous administrations the dose of drug is adjusted depending on a condition of function of marrow.

The recommended doses depending on the minimum indicators of blood after use of the first dose (in 1 ml):

• Leukocytes of more than 3000 and/or thrombocytes more than 75 000 – the dose similar to the first;
• Leukocytes 2000-2999 and/or thrombocytes more than 25 000-74 999 – 70% of the previous dose;
• Leukocytes of less than 2000 and/or thrombocytes less than 25 000 - 50% of the previous dose.

If before the following course of therapy indicators of blood were recovered (i.e. leukocytes reached ^{level 4000/mm3} and thrombocytes – ^{100 000/mm3} blood), Mitomitsin-S Kiov can be entered in the doses corrected according to the table.

In case of purpose of drug in a combination with other myelosuppressive means the dose of a mitomitsin should be corrected as appropriate.

Side effects

• System of a hemopoiesis: thrombocytopenia, leukopenia, anemia;
• Respiratory system: dry cough, an asthma, infiltrates in lungs;
• Urinary system: increase in concentration of creatinine in blood, development of the hemolitic uraemic syndrome which is followed by mikroangiopatichesky hemolitic anemia with fragmentation of erythrocytes and an anuretic form of an acute renal failure, and also thrombocytopenia; seldom – a fluid lungs, increase in arterial pressure, neuropathy, syncopal states, hemolitic anemia (at the patients receiving митомицин intravenously as monodrug or in combination with other cytostatics in doses more than 60 mg);
• Alimentary system: stomatitis, abnormal liver function, esophagitis, diarrhea, anorexia, nausea, vomiting;
• Cardiovascular system: development or aggravation of heart failure (at the patients who were earlier receiving doxorubicine), reduction of contractility of a myocardium;
• Skin and its appendages: crimson strips on nails, skin rash or ulcerations, a reversible alopecia;
• Others: the increased weakness or fatigue, feeling of a pricking or numbness in fingers of hands and legs, fervescence;
• Local reactions: thrombophlebitis, rash and an itch in genitals and on hands; in case of hit of solution under skin – pain, reddening, an inflammation of a hypodermic fatty tissue and a necrosis; at intravesical introduction – the increased urination frequency, night enuresis, cystitis, dysuric frustration, irritation of urinogenital ways, a bladder atrophy, a hamaturia and other symptoms of local irritation.

Special instructions

Mitomitsinom-S Kiov's treatment has to be carried out under observation of the medical specialist having experience with antineoplastic medicines.

Intravenous administration has to be carried out slowly, with extra care not to allow hit of drug in ekstravazalny space.

All course of treatment and within 8 weeks after its termination it is necessary to control indicators of peripheral blood (amount of hemoglobin, thrombocytes, leukocytes and neutrophils), and also concentration of urea and creatinine in blood serum.

Within 3 months after the termination of a course of antineoplastic therapy all patients (both women, and men) should use reliable methods of contraception.

Medicinal interaction

The patients who were earlier receiving doxorubicine during treatment mitomitsiny have a probability of development of congestive heart failure.

Strengthening of toxicity of a mitomitsin is possible at simultaneous performing radiation therapy or use of the drugs having nephrotoxic and myelotoxic effect.

In case of preliminary or simultaneous with mitomitsiny introductions of vinkaalkaloid development respiratory a distress syndrome is possible. This syndrome was also noted at the patients receiving an oxygenotherapy (inhalation of the mix containing more than 50% of oxygen) during use of a mitomitsin.

Terms and storage conditions

To store at a temperature up to 30 °C in the place, unavailable to children.

Period of validity – 4 years.