Adult Dosing

Adenocarcinoma of stomach or pancreas

• 20 mg/m² IV q6-8 wks
• Reevaluate patient for myelosuppression, after each course of mitomycin

Note:

• Adjust dose if used in combination with other myelosuppressive agents, if disease progress drug should be stopped since chances of response are minimal
• Refer package insert for toxicity-related dose adjustments

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Palliative treatment of disseminated adenocarcinoma of stomach or pancreas in combination with other approved chemotherapeutic agents

• Hypersensitivity to any of the ingredients of the product
• History of idiosyncratic reaction
• Thrombocytopenia
• Coagulation disorder
• Serum creatinine >1.7 mg

• Mitomycin should be administered only under supervision of physician experienced in cancer chemotherapy in adequate medical facility where adequate diagnostic and treatment facilities are readily available
• Bone marrow suppression, thrombocytopenia and leukopenia, are most frequently occurring toxic effects of mitomycin
• Patients receiving systemic mitomycin have reported hemolytic uremic syndrome (HUS), this syndrome may occur during mitomycin monotherapy or in combination with other cytotoxic drugs
• This may occur at anytime during therapy. Most cases occur at dosages greater than 60 mg.
• Blood product transfusion may worsen symptoms associated with hemolytic uremic syndrome (HUS). Incidence of this syndrome has not been defined

Renal Dose Adjustment (Based on serum creatinine)

• >1.7 mg/dl: Contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Monitor patients treated with mitomycin carefully and frequently during and after therapy
• Bone marrow suppression, thrombocytopenia and leukopenia, are most frequently occurring toxic effects of mitomycin. Therefore examine platelet count, WBC count, differential, and hemoglobin during therapy and for at least 8 weeks following therapy
• If platelet count <100,000/mm³ or a WBC <4,000/mm³ is evaluated, patient should withhold further therapy until blood counts is recovered
• Advise patient about potential toxicity of this drug, particularly bone marrow suppression
• Incidences of death have been occurred due to drug as a result of leukopenia
• Administration of vinca alkaloids in patients who are receiving mitomycin have reported acute shortness of breath and severe bronchospasm; however acute respiratory distress has occurred within minutes to hours after the vinca alkaloid injection and when taken in combination with other chemotherapy

Pregnancy Category:D

Breastfeeding: Avoid use. It is unknown whether if mitomycin is excreted in human milk. Manufacturer advises that women receiving mitomycin should not breastfeed because of the potential for serious adverse reactions from mitomycin in nursing infants.

• CV: CHF, hypertension
• NEURO: Neurologic abnormalities
• GI: Stomatitis, anorexia, nausea, vomiting, ulceration
• GU: Renal failure
• HEMA: Thrombocytopenia, leukopenia, hemolytic uremic syndrome, sepsis, anemia
• METABOLIC: Elevated Cr
• DERM: Extravasation necrosis, alopecia, erythema
• RESP: Interstitial pneumonitis, ARDS, dyspnea, pulmonary edema
• MISC: Fever, hepatic dysfunction
• LOCAL: Cellulitis injection site

• Antibiotic; inhibits DNA synthesis and function; by causing cross-linking, and also suppress RNA and protein synthesis
• Metabolized by liver; CYP450: Unknown
• Excreted in urine (10% unchanged)
• Half-life: 8-48 minutes

US Trade Name(s)

• Only generic available

US Availability

mitomycin (generic)

• PWDR for INJ: 5 mg/vial
• PWDR for INJ: 20 mg/vial
• PWDR for INJ: 40 mg/vial

Canadian Trade Name(s)

• Only generic available

Canadian Availability

mitomycin (generic)

• PWDR for INJ: 5 mg/vial
• PWDR for INJ: 20 mg/vial

UK Trade Name(s)

• Mitomycin-C Kyowa

UK Availability

Mitomycin-C Kyowa

• PWDR for INJ: 2 mg/vial
• PWDR for INJ: 10 mg/vial
• PWDR for INJ: 20 mg/vial
• PWDR for INJ: 40 mg/vial

Australian Trade Name(s)

• Mitomycin-C Kyowa

Australian Availability

Mitomycin-C Kyowa

• PWDR for INJ: 2 mg/vial
• PWDR for INJ: 10 mg/vial
• PWDR for INJ: 20 mg/vial

[Outline]

Hematology/Oncology

Antineoplastics

Antibiotics/Antineoplastics