Crystalline Mitomycin-C

Indications

Crystalline Mitomycin-C 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 Dose

Adult: IV Solid tumours Suggested regimen: Initial: 10-20 mg/m2; may repeat 6-8 wkly 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-mthly.

Child Dose

Safety and efficacy not established

Renal Dose

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

Administration

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

Contra Indications

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

Precautions

Repeated haematologic studies are necessary during treatment and for at least 7 wk after discontinuation of the drug. Discontinue use when the leucocyte count decreases to <4000/mm3 or the platelet count decreases to <150,000/mm3 or if a progressive decline in either occurs. Monitor patient for signs of renal or pulmonary toxicity.

Pregnancy-Lactation

Pregnancy Category: D Lactation: Not known if excreted in breast milk, do not nurse

Interactions

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.

Adverse Effects

Side effects of Crystalline Mitomycin-C : >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.

Mechanism of Action

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.