Mitomycin Injection

Mitomycin Injection is used for: Diabetic foot infections, Chronic lymphatic leukaemia, Chronic myelogenous leukaemia, Gastric carcinoma, Colorectal carcinoma, Lung carcinoma, Pancreatic carcinoma, Carcinoma Cervix, Endometrium carcinoma, Carcinoma Breast, Bladder carcinoma, Head & neck carcinoma.

Adult: IV Solid tumours Suggested regimen: Initial: 10-20 mg/m2; may repeat 6-8 weeks depending on blood count. Do not repeat if leucocyte and platelet counts are below acceptable levels. Do not re-administer if the nadir of the leucocyte count is <2,000 cells/mm3. Intravesical Superficial bladder tumours Instill 10-40 mg 1-3 times/wk for a total of 20 doses. Prevention of recurrent bladder tumours Instill 20 mg 2 wkly or 40 mg 1-3-monthly.

Safety and efficacy not established

Renal Impairment Serum creatinine >1.7 mg/dL: Avoid use CrCl <10 mL/min: Decrease dose by 25% CAPD: Decrease dose by 25%

IV Preparation Reconstitute with SWI to a concentration of 0.5 mg/mL IV Administration Administer slow IV push by central line only Flush with 5-10 mL of IV solution before & after drug administration

Thrombocytopenia, coagulation disorders, increase in bleeding tendency due to other causes. Renal impairment, potentially severe infections. Pregnancy and lactation.

The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to manage complications Bone marrow suppression, notably thrombocytopenia and leucopenia, may contribute to overwhelming infections in an already compromised patient Hemolytic uremic syndrome may occur with monotherapy or combination therapy and usually occurs with doses >60 mg. Blood product transfusion may exacerbate symptoms Increased prevalence of Heart Failure observed when used in conjunction with anthracyclines Patients receiving therapy must be observed carefully and frequently during and after therapy Patients receiving mitomycin should be observed for evidence of renal toxicity; mitomycin should not be given to patients with serum creatinine greater than 1.7 mg percent Ureteric Obstruction: Ureteric obstruction may occur. Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and to use effective contraception. Mitomycin is a known mutagen and clastogen; this drug has been shown to be positive in the Ames bacterial mutation assay, chromosomal aberrations assay in mice, Chinese hamsters and human lymphocytes, unscheduled DNA synthesis assay in human lymphocytes, micronucleus test in mice and human lymphocytes and somatic mutation and recombination assays in Drosophila melanogaster Bone marrow depression Therapy results in high incidence of bone marrow suppression,particularly thrombocytopenia, and leukopenia; therefore, the following studies should be obtained repeatedly during therapy and for at least eight weeks following therapy; these include platelet count, white blood cell count, differential, and hemoglobin Bladder toxicity Bladder fibrosis/contraction reported with intravesical administration of mitomycin (not an approved route of administration), which in rare cases has required cystectomy Pulmonary Acute shortness of breath and severe bronchospasm reported following administration of vinca alkaloids in patients who had previously or simultaneously received mitomycin The onset of this acute respiratory distress occurred within minutes to hours after vinca alkaloid injection; the total number of doses for each drug has varied considerably Renal toxicity Patients receiving therapy should be observed for evidence of renal toxicity; this drug should not be given to patients with serum creatinine >1.7 mg percent. Nephrotoxicity, including irreversible renal necrosis, was observed in rodents and non-rodents following parenteral administration of HPβCD, the excipient contained in this drug MONITORING PARAMETERS Monitor CBC, LFTs, renal function Do not repeat dose until WBC >4000/mm³ and Plts >100,000/mm³ Monitor patient for signs of renal or pulmonary toxicity.

Pregnancy Based on findings in animals and mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; there are no available data on use in pregnant women to inform the drug-associated risk; in animal reproduction studies, administration of mitomycin resulted in teratogenicity; advise pregnant women of the potential risk to a fetus Verify pregnancy status in females of reproductive potential prior to initiating therapy Contraception Females: Advise females of reproductive potential to use effective contraception during treatment with and for 6 months following the last dose Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with and for 3 months following the last dose Animal data Teratological changes have been noted with mitomycin in animal studies Lactation There are no data on the presence of mitomycin in human milk, the effects on breastfed children, or on milk production; because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 1 week following the last dose

Increased incidence of cardiotoxicity w/ doxorubicin. Potentially Fatal: Increased risk of intravascular haemolysis and renal failure w/ fluorouracil. Increased risk of haemolytic uraemic syndrome w/ tamoxifen. Acute pulmonary toxicity w/ vinca alkaloids (e.g. vinblastine, vinorelbine). Increased bone marrow depressant effects of aclarubicin. Contraindicated (0) Serious (9) bacitracin deferiprone erdafitinib etrasimod lasmiditan palifermin ropeginterferon alfa 2b sotorasib tepotinib

Side effects of Mitomycin C (Crystalline) : >10% Hemolytic uremic syndrome (<15%),Myelosuppression (64%),Nausea/vomiting (14%),Fever (14%) 1-10% Stomatitis (4%),Increased serum creatinine (2%),Mucous membrane toxicity (4%) Frequency Not Defined Fatigue,Pulmonary toxicity,Dyspnea,Cystitis,Interstitial fibrosis,Nephrotoxicity,Amenorrhea,Alopecia Potentially Fatal: Myelosuppression, haemolytic-uraemic syndrome.

Mitomycin is an antineoplastic antibiotic which is enzymatically reduced to its active metabolite within susceptible cells. The active metabolite appears to cause cross-linking of DNA (primarily with guanine and cytosine pairs). It also active against gram-positive bacteria and some viruses, but its antineoplastic activity precludes its use as an antibiotic.

Mitomycin 2mg Injection manufactured by Kyowa Hakko Kogyo Co., Ltd.,Japan. Its generic name is Mitomycin C (Crystalline). Mitomycin is availble in Bangladesh. Farmaco BD drug index information on Mitomycin Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.