Crystalline Mitomycin-C

Crystalline Mitomycin-C 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 is also active against gram-positive bacteria and some viruses, but its antineoplastic activity precludes its use as an antibiotic. It is used for diabetic foot infections, chronic lymphatic leukaemia, chronic myelogenous leukaemia, gastric, colorectal, lung, pancreatic, cervical, endometrial, breast, bladder, and head & neck carcinoma.

• 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

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 is also active against gram-positive bacteria and some viruses, but its antineoplastic activity precludes its use as an antibiotic.

Mitomycin is an antineoplastic antibiotic which is enzymatically reduced to its active metabolite within susceptible cells. The active metabolite causes cross-linking of DNA (primarily with guanine and cytosine pairs), which disrupts DNA replication and transcription, leading to cell death.

Adult Dose (IV - Solid Tumours): Initial: 10-20 mg/m²; may repeat 6-8 weekly depending on blood count. Do not repeat if leucocyte and platelet counts are below acceptable levels. Do not re-administer if nadir of leucocyte count is <2,000 cells/mm³.

Adult Dose (Intravesical - Superficial Bladder Tumours): Instill 10-40 mg 1-3 times/week for a total of 20 doses.

Prevention of Recurrent Bladder Tumours: Instill 20 mg every 2 weeks or 40 mg every 1-3 months.

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

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

Intravesical Administration: Instill into the bladder.

If you miss a dose of Crystalline Mitomycin-C, please consult your doctor.

Common Side Effects (>10%):

• Hemolytic uremic syndrome (<15%)
• Myelosuppression (64%)
• Nausea/vomiting (14%)
• Fever (14%)

Less Common Side Effects (1-10%):

• Stomatitis (4%)
• Increased serum creatinine (2%)
• Mucous membrane toxicity (4%)

Other Side Effects: Fatigue, Pulmonary toxicity, Dyspnea, Cystitis, Interstitial fibrosis, Nephrotoxicity, Amenorrhea, Alopecia.

Potentially Fatal: Myelosuppression, haemolytic-uraemic syndrome.

• Repeated haematologic studies are necessary during treatment and for at least 7 weeks 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.
• Caution in thrombocytopenia, coagulation disorders, increased bleeding tendency, renal impairment, and potentially severe infections.

• Thrombocytopenia
• Coagulation disorders
• Increased bleeding tendency due to other causes
• Renal impairment
• Potentially severe infections
• Pregnancy and lactation

Increased incidence of cardiotoxicity with doxorubicin. Increased risk of intravascular haemolysis and renal failure with fluorouracil. Increased risk of haemolytic uraemic syndrome with tamoxifen. Acute pulmonary toxicity with vinca alkaloids (e.g., vinblastine, vinorelbine). Increased bone marrow depressant effects of aclarubicin.

No food interactions have been found or established.

Pregnancy Category D. May cause fetal harm during pregnancy. Contraindicated during pregnancy and lactation.

It is not known whether mitomycin is excreted in human breast milk; do not nurse.

The safety and effectiveness of Crystalline Mitomycin-C in pediatric patients have not been established.

Limited information is available regarding dose adjustment for elderly patients.

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

Limited information is available regarding use in hepatic impairment.

Crystalline Mitomycin-C overdose symptoms include severe myelosuppression, nausea, vomiting, and mucositis. In case of overdose, symptomatic and supportive treatment should be given.

Keep out of reach of children. Store in a cool and dry place.

Mitomycin-C