Mitomycin
Other Cytotoxic Antibiotics
- Drug class
- Other Cytotoxic Antibiotics
- Availability
- Prescription only
- Routes
- Intravesicular, Intravesical, Intravenous
- Markets covered
- 3
- Products on record
- 13
- FDA reports (12 mo)
- 374
Overview
Mitomycin is an active pharmaceutical ingredient in the Other Cytotoxic Antibiotics group (L01DC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 7 | May 1, 2026 |
| CA Canada | Health Canada | 4 | May 26, 2025 |
| US United States | FDA | 2 | May 24, 2023 |
GBUnited Kingdom· MHRA
7 products
Uses
Mitomycin is used in palliative tumour therapy. Mitomycin is administered intravenously as monochemotherapy or in combined cytostatic chemotherapy in adults with: • advanced metastatic gastric carcinoma • advanced and/or metastatic breast cancer Furthermore mitomycin is administered intravenously in combined chemotherapy in adults with: • non-small cell bronchial carcinoma • advanced pancreatic carcinoma Intravesical administration for relapse prevention in adults with superficial urinary bladder carcinoma after transurethral resection.
How to take
CACanada· Health Canada
4 products
Uses
AND CLINICAL USE
Mitomycin for Injection is indicated in the palliative treatment as an adjunct to surgery, radiation or chemotherapy for adenocarcinoma of the stomach and colon. Mitomycin for Injection as a single agent is indicated as topical therapy for superficial (no invasion beyond the lamina propria) transitional cell carcinoma of the urinary bladder.
Efficacy has been demonstrated both in patients who have had no prior intravesical chemotherapy and in those who have failed such therapy with Thiotepa or other antineoplastic agents. CONTRAINDICATIONS Mitomycin for Injection is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.
Mitomycin for Injection is contraindicated in patients with thrombocytopenia, leukopenia, coagulation disorder, or an increased bleeding tendency due to other causes. Mitomycin for Injection is contraindicated for intravesical administration in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past.
USUnited States· FDA
2 products
Uses
INDICATIONS AND USAGE
Mitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed.
Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.
How to take
Drug interactions
Known interactions involving Mitomycin. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL200750389 · revised May 1, 2026
- [2]Health Canada (DPD) · 02557762 · revised May 26, 2025
- [3]FDA DailyMed · 0171a1c8-c474-4e… · revised May 24, 2023 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.