Mitomycin
When ATH:
L01DC03
Characteristic.
Antibiotic, produced by the fungal culture Streptomyces caespitosus. Substance thermostable, It has a high melting point, readily soluble in organic solvents. Molecular weight 334,33.
Pharmacological action.
Antitumor.
Application.
Disseminated adenocarcinoma of the stomach and pancreas (in combination with other anticancer drugs, preferably with fluorouracil and doxorubicin), cancer vulyvы, cervix, endometrial, Breast, mesothelioma, esophageal carcinoma, bowel (incl. colorectal), liver, light, Bladder, prostate, Head and Neck (monotherapy or palliative treatment after failure of prior therapy), chronic lymphatic- and myeloid leukemia.
Contraindications.
Hypersensitivity, incl. the phenomenon of intolerance or hypertensive reaction in response to the introduction of mitomycin history, thrombocytopenia, coagulopathy, incl. a tendency to bleeding, pregnancy, lactation.
Restrictions apply.
Violations of the bone marrow, liver, kidney (creatinine level in serum more 0,15 mmol / l), infectious diseases, osobenno enable vetryanaya, incl. recently transferred (possible serious complications with subsequent fatal), herpes zoster (the risk of severe generalized disease), previous treatment with cytotoxic drugs or radiation therapy, childhood.
Pregnancy and breast-feeding.
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.
Side effects.
Cardio-vascular system and blood (hematopoiesis, hemostasis): most often, thrombotic- leukopenia, or with the possible development of septicemia (occur in the first 8 weeks of treatment), Cumulative myelosuppression, congestive heart failure.
From the respiratory system: rarely is pulmonary toxicity (breathlessness, dry non-productive cough, pulmonary infiltrates), interstitial pneumonia, acute respiratory distress syndrome (in combination with other chemotherapeutic agents, particularly those containing vinca alkaloids, or by inhalation of a mixture of, containing a 50% oxygen, during premedication).
From the digestive tract: nausea, vomiting (during the first 1-2 h after the introduction), diarrhea, anorexia, stomatitis, abnormal liver function.
With the genitourinary system: increased creatinine, proteinuria, hematuria, swelling, cystitis, atrophy of the bladder (when intravesical), nephrotoxicity in the form of hemolytic-uremic syndrome (mikroangiopatičeskaâ hemolytic anemia-hematocrit not more 25%, irreversible kidney failure, тромбоцитопения — число тромбоцитов менее 100·109/l, less often — pulmonary hypertension, neurological disorders and hypertension).
For the skin: reversible hair loss, skin rash (rarely), эritema, purple stripes on the nails (occur with repeated doses).
Other: headache, fever, cellulitis, thrombophlebitis at the injection site, necrosis, extravasates.
Cooperation.
Preparations, causing depression of bone marrow function, and radiotherapy additive depress bone marrow function. Preparations, possessing nephrotoxic effect, increase toxic effects on the kidneys. Doxorubicin, incl. Assigns previous, increases cardiotoxicity (possible development of congestive heart failure). Interactions (or simultaneously) with the introduction of vinca alkaloids, and inhalation mixture before surgery, containing a 50% oxygen, patients, treated with mitomycin, It may be accompanied by the development of acute respiratory distress syndrome. Reduces the effect of inactivated viral vaccines, may increase side effects in live virus vaccines.
Dosing and Administration.
B /, intravesically. The dose and duration of treatment is determined individually, depending on the severity of the disease, condition and age of the patient. B / drip: When alone — in a single dose 20 mg / m2 at intervals of 4-6 weeks or 2 mg / m2 1 once a day 5 days per week for 2 Sun (from 1 by 5 and 8 by 12 days course), or 8-10 mg/m2 in 1 and 8 4-5 days kazhdыe Sun. First (20 mg / m2) вводят полностью при числе лейкоцитов не менее 3·109/l, 50% дозы — при уровне ниже 2·109/l; possible re-introduction, если число лейкоцитов не менее 4·109/л и тромбоцитов не менее 100·109/l.
When bladder cancer - Intravesically, for 20-60 mg (divorced in 20-40 ml of sterile water or saline solution) 1 once a week for 6-8 weeks.
Solution prepared immediately before use, the rate of 2 mg active substance for 5 mL of solvent.
Precautions.
Therapy should be under a doctor's supervision, having experience of anticancer drugs. Patients are advised to warn about the possible grave consequences of the treatment. Long-term treatment requires careful monitoring (tk. may develop severe and long-lasting side effects, incl. infectious, inflammatory diseases and bleeding). During treatment and for 7-8 weeks after the end of a regular monitoring of peripheral blood cell, functional parameters of the liver and kidneys; In case of any abnormality during therapy dose reducyruut. It should be taken into account, that the picture of the blood through the normal 10 weeks after cessation of therapy, however, approximately 25% cases, there is no normalization). Occurs after the introduction of the vomiting usually stops after 3-4 h, and nausea can last for 2-3 days.
Frequency of haemolytic uraemic syndrome higher dose Mitomycin 60 mg, and more. It should be taken into account, that the development of this syndrome in 50% cases occurred death.
In / injected only slowly, with great care, avoiding extravasation.
After the initial treatment dose corrected for hematologic response and the individual characteristics of the patient.
If the 2 courses of mitomycin clinical response was observed, the therapeutic effect is unlikely.
The occurrence of thrombocytopenia necessitates extreme caution when performing invasive procedures and dental procedures, regular inspection of places on / in the, skin and mucous membranes (for signs of bleeding), limit frequency troublesome and the rejection of the / m injection, Control of blood in the urine, vomit, Kale. The patients must be carefully shave, manicure, brush your teeth, dentists use threads and toothpicks, to carry out prevention of constipation, avoid falls and other injuries, as well as the intake of alcohol and aspirin, increase the risk of gastrointestinal bleeding.
Patients who develop leukopenia may require antibiotics (in connection with a possible risk of infectious diseases). Neutropenic patients at elevated body temperature until the results of bacteriological tests empirically prescribed broad-spectrum antibiotics.
It is necessary to postpone the vaccination schedule and the patient living with him family members (conduct after 3-12 months after the last cycle of chemotherapy), should abandon immunization oral polio vaccine. It is recommended to avoid contact with infectious patients, or use non-event for the prevention of infection (face mask, etc.). During treatment should use appropriate contraceptive measures.
When the chill, fever, cough or hoarseness, pain in the lower back or side, painful or difficult urination, bleeding or hemorrhage, black stool, blood in the urine or feces should immediately consult a doctor.
If extra care is possible to use in children (increased risk of adverse reactions, and adverse impact on the function of the gonads). To use caution in the elderly (more likely to age renal dysfunction).
Care must be taken in combination therapy (each product must be taken in due time).
Avoid contact of mitomycin under the skin or soft tissue (causing local tissue necrosis). On education infiltration (local tissue damage and scarring), redness, pain or swelling at the injection site you must inform the doctor. In the formation of extravasates (burning or sharp pain at the injection site) administration should be discontinued immediately and restart in another vein.
It should strictly observe the specified interval between infusions (development of bone marrow function is slow in nature and related to the cumulation of mitomycin).
Cautions.
Observe safety measures and rules for preparation and dilution of mitomycin (in a sterile box with the use of disposable surgical gloves and masks) and disposal of needles, syringes, bottles, ampoules and unused residues of the drug.
Mitomycin may be used in combination with other cytotoxic drugs, such as fluorouracil, or doxorubicin.
