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  • Mitomycin C
    / Dexcel


    Active Ingredient
    Mitomycin C 10 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    5 X 10 mg

    partial basket chart 28004 13387

    Dosage

    Intermittent administration: Usually for adults, 4 to 6 mg (potency)/day of this drug is administered intravenously once or twice a week.
    Administration on consecutive days: Usually for adults, 2mg (potency)/day of this drug is administered intravenously every day.
    Intermittent massive administration: Usually for adults, 10 to 30 mg (potency)/day of this drug is administered intravenously every 1 to 3 weeks or at longer intervals.
    Concurrent use with other antineoplastic agents: Usually for adults, 2 to 4 mg (potency)/day of this drug is administered once or twice a week in combination with other anti-neoplastic agents. This drug may be administered, if necessary, intraarterially, intrathecally, intrapleurally or intraperitoneally at a usual dose of 2 to 10 mg (potency)/day of this drug in adults. The dosage may be adjusted depending on the age and symptoms of the patient.
    Use in patients with bladder tumor: For prophylactic use against recurrence, 4 to 10 mg (potency) of this drug is usually administered intravesically once every day or every other day. For therapeutic use, 10 to 40 mg (potency)/day of this drug is administered intravesically once a day. The dosage may be adjusted depending on the age and symptoms of the patient.
    For full details please see prescribing information.


    Indications

    Remission of subjective and objective symptoms associated with the following diseases: Chronic lymphocytic leukemia, chronic myelocytic leukemia, gastric cancer, colorectal cancer, lung cancer, pancreatic cancer, liver cancer, cervix cancer, cancer of endometrium, breast cancer, head and neck tumor and bladder tumor.


    Contra-Indications

    Patients with a history of serious hypersensitivity or idiosyncratic reaction to any of the components of the product. Thrombocytopenia, coagulation disorders and increased bleeding tendency.


    Special Precautions

    This drug should be administered under the supervision of a physician experienced in cytotoxic cancer chemotherapy. Local ulceration and cellulitis may be caused by tissue extravasation during intravenous injection and utmost care should be taken in administration. If extravasation occurs, it is recommended that the area is immediately infiltrated with sodium bicarbonate 8.4% solution, followed by an injection of 4 mg dexamethasone. A systemic injection of 200 mg of vitamin B6 may be of some value in promoting the regrowth of tissues that have been damaged. This drug should not be allowed to come into contact with the skin. If it does, it should be washed several times with 8.4% sodium bicarbonate solution, followed by soap and water. Hand creams and emollients should not be used as they may assist the penetration of the drug into the epidermal tissue.
    In the event of contact with eye, it should be rinsed several times with 8.4 % sodium bicarbonate solution. It should then be observed for several days for evidence of corneal damage. If necessary, appropriate treatment should be instituted.
    Careful Administration (Mitomycin C should be administered with care in the following patients.): Patients with hepatic or renal dysfunction [Adverse reactions may be enhanced.], Patients with bone marrow depression and bleeding tendency as these may be exacerbated. Patients complicated with infection [Administration of this product may aggravate infection due to bone marrow depression.] Patients with varicella [Fatal systemic disorders may occur.]
    Important Precautions: Patients should be carefully monitored with frequent laboratory testing (hematological test, liver function test, renal function test, etc.) because serious adverse reactions such as bone marrow depression may occur. If any abnormality is observed, appropriate measures such as reduction of the dose and suspension of administration should be taken. Additionally, Mitomycin C should be administered with care because long-term use of the product may cause enhanced adverse reactions, which may be protracted. Severe renal toxicity has occasionally been reported after treatment and renal function should be monitored before starting treatment and again after each course. Special cautions are required to the possible manifestation or aggravation of infectious disease and bleeding tendency. Precautions should be paid to possible occurrence of acute leukemia (In some cases following preleukaemic phase) or myelodysplastic syndrome (MDS) in patients treated with Mitomycin C in combination with other antineoplastic agents. Mitomycin C Injection should be administered with care in children, paying special attention to the manifestation of adverse reactions. In case administration of this drug is required in children or patients with reproductive possibility, potential effects on gonad should be considered.
    Precautions during administration:  Since intravenous administration may cause vascular pain, phlebitis, thrombus, injection site induration, necrosis, Mitomycin C should be injected as slowly as possible, paying careful attention to the site and method of administration.  Since extravascular leakage of the drug solution may cause induration or necrosis at the injection site, this drug should be injected cautiously to avoid extravascular leakage of the drug solution. Intraarterial administration may cause skin disorders such as ulcer, induration pain, redness, erythema, blisters and erosion in the region involved, which may lead to skin/muscle necrosis. Administration should be discontinued and appropriate measures should be taken, if any of such symptoms develops. In particular, parenchymatous liver disorder, biloma, cholangitis (also sclerosing), and bile duct necrosis may occur after hepatic arterial administration of the drug. Since the influx of the drug solution into other sites than the targeted site in the administration to the hepatic artery may cause gastroduodenal ulcer, haemorrhage, perforation, etc., the location of the end of catheter and drug distribution area should be confirmed photographically or by other means, paying attention to possible deviation or shift of the catheter and infusion rate. Administration should be discontinued and appropriate measures should be taken, if any of such symptoms develops. Since calcinosis, contracted bladder and cystitis associated with dysuria and pollakiuria, bladder perforation, bladder necrosis, penile necrosis may occur in patients receiving intravesical Mitomycin C Injection; the drug should be carefully injected.
    Pediatric Use: The safety of Mitomycin C in small for dates babies, neonates, infants and children has not been established.
    Use in the Elderly: Because elderly patients often have reduced physiological function, bone marrow depression, which may be protracted, and renal disorder are likely to occur. Mitomycin C should, therefore, be administered cautiously in elderly patients while closely monitoring patient’s condition and paying special attention to the dose and dosing interval.
    Precaution for preparation: Since the potency of Mitomycin C may be reduced when a low pH solution is used for reconstitution, it is recommended to use the solution soon after reconstitution. In addition it is recommended to avoid mixture with other low pH injectable solution.
    Other Precautions: Genesis of various types of tumors has been reported in animal experiments with mice by subcutaneous administration and with rats by intraperitoneal or intravenous administration.
    For full details please see prescribing information.


    Side Effects

    (At the end of reevaluation) The main adverse reactions collected from literature at the time of reevaluation were leucopenia in 130 (40.2%) of 323 patients, thrombocytopenia in 75 (24.7%) of 304 patients, anorexia in 58 (21.8%) of 266 patients, nausea/vomiting in 41 (15.4%) of 266 patients, malaise in 15 (5.6%) of 266 patients, weight loss in 18 (5.5%) of 329 patients, bleeding tendency in 12 (3.6%) of 329 patients and anaemia in 10 (3.0%) of 329 patients. Patients should be monitored closely during each course of treatment, paying particular attention to peripheral blood count including platelet count. No repeat dose should be given unless the leukocyte count is above 3.0*109/L or more and the platelet count is 90*109/L or more. The nadir is usually around four weeks after treatment and toxicity is usually cumulative, with increasing risk after each course of treatment. If disease progression continues after two courses of treatment, the drug should be stopped since the chances of response are minimal.
    Clinically significant adverse reactions: Marrow depression such as pancytopenia, leucopenia, neutropenia, thrombocytopenia, haemorrhage and anaemia may occur. Patients should be carefully observed with periodical testing, and, if any signs of abnormality are noted, appropriate measures such as reducing the dose and suspending administration should be taken. Haemolytic-uraemic syndrome and microangiopathic haemolytic anaemia may occur. Patients should be carefully observed with periodical testing, and, if symptoms such as anaemia with fragmented red blood cells, thrombocytopenia and renal dysfunction are observed, appropriate measures such as discontinuing treatment should be taken. Nausea and vomiting are sometimes experienced immediately after treatment, but these are usually mild and of short duration.
    Renal and urinary disorders: Serious renal disorder such as acute renal failure may occur. Patients should be carefully observed, and, if any abnormal change is noted in BUN, creatinine, creatinine clearance, etc., appropriate measures such as discontinuing treatment should be taken.
    Immune system disorders: Shock or anaphylactoid reaction may occur, patients should be carefully observed. If symptoms such as itching, rash, flushing, sweating, dyspnoea and decreased blood pressure occur, treatment should be immediately discontinued and appropriate measures should be taken.
    Respiratory, thoracic and mediastinal disorders: Pulmonary toxicities such as pulmonary oedema, interstitial pneumonia, pulmonary fibrosis (accompanied by fever, coughing, dyspnoea, abnormal findings on chest X-ray and eosinophilia), etc. may occur. Treatment should be discontinued and appropriate measures such as administration of adrenal cortex hormone should be taken, if any of these signs is observed.
    Hepatobiliary disorders: Administration to the hepatic artery may cause liver and biliary tract disorders (cholecystitis, cholangitis (also sclerosing), biloma, bile duct necrosis, parenchymatous liver disorder, etc.). Drug distribution area should be confirmed photographically or by other means, and treatment should be discontinued and appropriate measures should be taken if any of abnormal signs is noted.
    Skin disorders: Skin toxicity may occur in a small proportion of patients, with side effects such as alopecia (although this is less frequent and less severe than with certain other cytotoxic agents). Bleeding, rashes and mouth ulcers have been reported. The following administration related adverse reactions have also been reported: muscular pain, phlebitis, thrombus, induration or necrosis at the injection site, pain, redness erythema, blisters, erosion and ulceration which may lead to skin/muscle necrosis.
    Other adverse reactions: Such adverse reactions as listed below may occur. Patients should be carefully observed, and, if any abnormality occurs, appropriate measures such as reducing the dose and suspending administration should be taken.
    Very common: Anorexia, Nausea and Vomiting, Cystitis, Haematuria, Malaise.
    For full details please see prescribing information.


    Drug interactions

    Mitomycin C should be administered with care when coadministered with the following drugs:
    Other antineoplastic agents, Irradiation: Adverse reactions such as bone marrow depression may be enhanced. Adverse reactions of each other drugs are enhanced.
    Vinca alkaloid antineoplastic agents, Vincristine sulfate Vinblastine sulfate Vindesine sulfate etc.:  Breath shortness and bronchospasm may occur. Mechanism of action is not known.


    Pregnancy and Lactation

    Pregnancy: Administration of this drug is not recommended in pregnant women or women who may possibly be pregnant. [Animal studies with mice have shown teratogenicity of this drug manifested as developmental inhibition, cleft palate, hypoplastic tail, hypoplastic jaws, ectrodactyly, etc.]
    Lactation: Nursing mothers should discontinue breast feeding during treatment. [The safety of this drug in nursing mothers has not been established.]


    Overdose

     Some cases of overdose have been reported to the manufacturer. An increase in the more common side effects should be expected, such as fever, nausea, vomiting and myelosupression. Strict monitoring of the patient and appropriate treatment should be performed.


    Manufacturer
    Kyowa Hakko Kirin Co. Ltd. Japan
    Licence holder
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