mitomycin [IV]

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

Indications ⬆ ⬇

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

Contraindications ⬆ ⬇

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

Black Box Warnings ⬆ ⬇

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

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment (Based on serum creatinine)

>1.7 mg/dl: Contraindicated

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

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/Breast Feeding ⬆ ⬇

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.

Adverse Reactions ⬆ ⬇

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

Clinical Pharmacology ⬆ ⬇

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

Brands and Availability ⬆ ⬇

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