Mitomycin is a potent antineoplastic antibiotic derived from *Streptomyces caespitosus*. It functions as a bioreductive alkylating agent, requiring intracellular enzymatic activation to form cytotoxic DNA cross-links. The 40mg vial is a high-strength formulation used in specific, intensive chemotherapy regimens, primarily for advanced solid tumors. It is a vesicant and must be administered with extreme care to avoid extravasation.
Adult: VARIES WIDELY BY PROTOCOL. Common systemic dose: 10-20 mg/m² IV as a single dose, repeated every 6-8 weeks. For some regimens (e.g., FAM): 10 mg/m² IV on day 1 every 8 weeks. The 40mg vial allows for dosing in patients with higher Body Surface Area (BSA >2.0 m²) or for specific intensive protocols. Dose is ALWAYS calculated based on Body Surface Area (BSA).
Note: FOR INTRAVENOUS USE ONLY. Reconstitute 40mg vial with 20-40 mL of Sterile Water for Injection to yield a concentration of 1-2 mg/mL. Further dilute in 100-200 mL of 0.9% Sodium Chloride Injection. Administer as a slow IV infusion over 15-30 minutes. MUST be given through a free-flowing IV line, preferably a central line, with careful monitoring to avoid extravasation (causes severe tissue necrosis). Pre-medication with antiemetics is standard.
Mitomycin is a prodrug that undergoes enzymatic bioreduction (primarily in hypoxic tumor cells) of its quinone moiety. This generates reactive intermediates (hydroquinone, semiquinone) that undergo rearrangement to form bifunctional (or trifunctional) alkylating species. These active compounds form covalent cross-links between complementary strands of DNA, primarily at the N6 position of adenine and the O6 and N2 positions of guanine, inhibiting DNA synthesis and transcription.
Pregnancy: FDA Pregnancy Category D. There is positive evidence of human fetal risk based on its mechanism. Can cause fetal harm. Contraindicated. Women of childbearing potential must use effective contraception during and for at least 6 months after therapy.
Driving: May cause fatigue, malaise, dizziness, or blurred vision. Patients should be cautioned against driving or operating machinery if they experience these effects.
| Other Myelosuppressive Agents (e.g., Cisplatin, Gemcitabine, Radiotherapy) | Additive or synergistic bone marrow toxicity. Risk of severe pancytopenia. | Major |
| Live Vaccines (e.g., MMR, Varicella, Yellow Fever) | Risk of disseminated vaccine-induced infection due to immunosuppression. | Major |
| Cimetidine | May inhibit the hepatic microsomal enzyme system, potentially increasing mitomycin toxicity. Avoid concurrent use. | Moderate |
| Vitamin K Antagonists (Warfarin) | Mitomycin may alter prothrombin time; increased risk of bleeding or thrombosis. Monitor INR closely. | Moderate |
| Doxorubicin/Other Anthracyclines | Increased risk of cardiotoxicity, especially with prior anthracycline exposure. | Moderate |
Same composition (Mitomycin (40mg)), different brands: