Mitomycin-S Kiowa is a drug used to treat malignant tumors.
Release form and composition
Mitomycin-S Kiov is produced in the form of a powder for preparing an injection solution: blue-violet crystals or crystalline powder (in 2, 10 or 20 mg vials, 10 vials each, 2 mg per carton; 1 bottle of 10 or 20 mg each in a carton box).
The composition of 1 bottle includes:
- Active ingredient: mitomycin - 2, 10 or 20 mg;
- Auxiliary component: sodium chloride.
Indications for use
Mitomycin-C Kiov is used to treat such malignant neoplasms as: cancer of the stomach, pancreas, liver, bile ducts, colon and rectum, esophagus, breast, cervix, endometrium, vulva, bladder, prostate, ureters and kidney pelvis, malignant head and neck tumors, non-small cell lung cancer, mesothelioma.
- Severe renal impairment;
- Marked inhibition of bone marrow function;
- Increased bleeding, bleeding disorders;
- Pregnancy and lactation;
- Hypersensitivity to the drug.
Mitomycin-S Kiova is used with caution in childhood, with acute infectious diseases of bacterial, viral or fungal etiology.
Dosing and Administration
The solution prepared from Mitomycin-S Kiowa is injected intravesically (bladder tumors) or intravenously in a stream. Allowed the introduction of the drug intraperitoneally, intrapleural, intraarterial (if necessary).
To prepare the solution, the powder is dissolved with water for injection to a concentration of 0.4 mg per 1 ml.
The dosage of the drug is determined by the doctor individually. It is determined by the indications used by the scheme of antitumor treatment, the patient's condition.
Recommended dosing regimen:
- 20 mg per 1 m 2 intravenously 1 time in 28-42 days;
- At 2 mg per 1 m 2 intravenously at 1-5 and 8-12 days every 28-42 days;
- At 10 mg per 1 m 2 intravenously at 1 day every 42-56 days in combination with other cytostatics;
- At 30-40 mg in 30-60 ml (at a concentration of not more than 1 mg per 1 ml) of a sterile aqueous solution intravesically weekly, for 42-56 days and then monthly for 6 months.
Due to the fact that mitomycin may cause cumulative myelosuppression, the dose of the drug in subsequent administrations is recommended to be adjusted depending on the severity of bone marrow function.
Depending on the minimum blood parameters after the introduction of the previous dose of Mitomycin-C Kiov is recommended to use as follows:
- 100% of the dose: with the value of leukocytes> 3000, platelets> 75000;
- 70% of the dose: with the value of leukocytes in the range of 2000-2999, platelets - 25000-74999;
- 50% of the dose: with the value of leukocytes <2000, platelets <25000.
In the case when the recovery of blood parameters (leukocytes up to 4000 / mm 3 and platelets up to 100000 / mm 3 of blood) is observed before the start of the planned next course of therapy, the drug can be administered in an adjusted dose. When using Mitomycin-C Kiov in combination with other myelosuppressive drugs, its dose is recommended to be adjusted.
During the use of Mitomycin-C Kiov, disturbances can occur on the part of some body systems:
- Hematopoietic system: anemia, thrombocytopenia, leukopenia, cumulative myelosuppression;
- Respiratory system: infiltrates in the lungs, dry cough, shortness of breath;
- Urinary system: hemolytic uremic syndrome, accompanied mainly by anuric form of acute renal failure, microangiopathic hemolytic anemia with erythrocyte fragmentation, thrombocytopenia (less often - increased blood pressure, neuropathy, syncopal states, pulmonary edema, increased serum creatinine;
- Digestive system: abnormal liver function, diarrhea, anorexia, nausea, vomiting, esophagitis or stomatitis;
- Skin and skin appendages: purple stripes on the nails, sometimes skin rash or ulceration, reversible alopecia;
- Cardiovascular system: development or aggravation of the course of heart failure (in patients previously treated with doxorubicin), reduction of myocardial contractility;
- Local reactions: thrombophlebitis, if the solution gets under the skin - pain, redness, inflammation of the subcutaneous fatty tissue, necrosis;
- Others: fatigue, weakness, fever, tingling or numbness in the fingers and toes;
- For intravesical administration: rash and itching on the hands and in the genital area, atrophy of the bladder, hematuria and other symptoms of local irritation, cystitis, increased frequency of urination, nocturnal enuresis, dysuric disorders, irritation of the urinary tract.
Mitomycin-C Kiova is recommended to be used under the supervision of a physician with experience in working with anticancer drugs.
For intravenous use, the solution is injected only slowly, preventing it from entering extravasal space.
During the course of therapy and for 56 days after its termination, the indicators of peripheral blood and serum creatinine and urea concentrations should be monitored.
During treatment and for 3 months after its termination, men and women should use reliable methods of contraception.
When using mitomycin in combination with radiation therapy or drugs that have a nephrotoxic and myelotoxic effect, toxicity may increase.
In case of preliminary or simultaneous administration of the drug to patients receiving vinca alkaloids or oxygen therapy (inhalation mixture with an oxygen content of more than 50%), respiratory distress syndrome may develop.
Patients who have previously received doxorubicin therapy may develop congestive heart failure with the use of mitomycin.
Terms and conditions of storage
Keep out of reach of children at temperature up to 30 ° С.
Shelf life - 4 years.