Mitomycin (2mg)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Mitomycin is a potent antineoplastic antibiotic derived from *Streptomyces caespitosus*. It functions as a bioreductive alkylating agent, requiring intracellular enzymatic activation to form cross-links in DNA, leading to inhibition of DNA synthesis and cell death. It is a key component in the management of various solid tumors and is uniquely used in ophthalmology for glaucoma surgery.

OnsetDurationBioavailability
Cytotoxic effects begin within hours of administration, but clinical tumor response may take several weeks to become evident.The cytotoxic effect is prolonged due to its DNA cross-linking, which is not easily repaired. Hemotoxicity (myelosuppression) is delayed and cumulative, with nadir typically occurring 4-8 weeks after a dose.Not applicable for intravenous use (100% bioavailable). For intravesical use in bladder cancer, systemic absorption is minimal (<10%) with intact bladder mucosa.

2. Mechanism of Action

Mitomycin is a prodrug that requires enzymatic bioreduction (via NADPH-cytochrome c reductase, DT-diaphorase) in hypoxic tumor cells to generate reactive intermediates. These intermediates act as bifunctional or trifunctional alkylating agents, forming covalent cross-links primarily between the N-2 positions of adjacent guanine residues on complementary strands of DNA. This inhibits DNA synthesis and transcription, leading to single-strand breaks and cell cycle arrest, predominantly in the late G1 and S phases.

3. Indications & Uses

  • Adenocarcinoma of stomach or pancreas (as part of combination therapy)
  • Superficial Transitional Cell Carcinoma (TCC) of the Urinary Bladder (intravesical instillation)
  • Anal Cancer (in combination with 5-Fluorouracil and radiotherapy)
  • Prevention of fibrosis/scarring in Glaucoma Filtration Surgery (Mitomycin C-soaked sponges applied intraoperatively)

4. Dosage & Administration

Adult Dosage: **IV:** 10-20 mg/m² as a single dose every 6-8 weeks. Commonly 10 mg/m². Dose is part of a combination regimen. **Intravesical:** 20-40 mg in 20-40 mL sterile water instilled into the bladder weekly for 8 weeks, then monthly for up to 1 year. **Ophthalmic (Surgery):** 0.2-0.4 mg/mL solution applied via soaked sponge for 2-5 minutes, followed by copious irrigation.

Administration: **IV Route:** Reconstitute with Sterile Water for Injection. Administer as a slow IV push or short infusion (5-10 minutes) through a **freely flowing IV line**. **EXTRAVASATION HAZARD:** Must be administered by personnel trained in handling vesicants. **Intravesical:** Patient should restrict fluids prior, instil drug, retain for 1-2 hours, reposition every 15 minutes, then void.

5. Side Effects

Common side effects may include:

  • Myelosuppression (Leukopenia, Thrombocytopenia - delayed and cumulative)
  • Nausea and vomiting (moderate)
  • Anorexia
  • Malaise/fatigue
  • Alopecia (mild to moderate)
  • Local tissue damage/necrosis on extravasation

6. Drug Interactions

DrugEffectSeverity
Other Myelosuppressive Agents (e.g., Doxorubicin, Cyclophosphamide)Additive bone marrow toxicity. Increased risk of severe leukopenia/thrombocytopenia.Major
Live Vaccines (e.g., MMR, Varicella, Yellow Fever)Risk of disseminated infection due to immunosuppression. Vaccination contraindicated.Major
CimetidineMay inhibit hepatic microsomal enzymes, potentially increasing Mitomycin toxicity.Moderate
Vitamin K Antagonists (Warfarin)Increased risk of bleeding due to thrombocytopenia and possible interference with coagulation.Moderate
RadiotherapyEnhanced toxicity in irradiated fields (recall phenomenon). Increased risk of pulmonary toxicity.Major

7. Patient Counselling

  • Do report any signs of infection (fever, chills, sore throat) immediately.
  • Do maintain good oral hygiene to reduce risk of stomatitis.
  • Do use effective contraception during and for at least 6 months after treatment.
  • Do not receive any live vaccinations without consulting your oncologist.
  • Do not conceive or father a child during treatment.
  • For intravesical therapy: Void completely after the prescribed retention time and wash genital area to prevent skin irritation.

8. Toxicology & Storage

Overdose: Exacerbation of all major toxicities: Severe, prolonged myelosuppression (pancytopenia), renal failure, HUS, pulmonary edema/interstitial pneumonitis, myocardial damage, and septic shock.

Storage: Store unopened vials at 2°C to 8°C (refrigerated). Protect from light. Reconstituted solution with Sterile Water for Injection is stable for 14 days under refrigeration (2-8°C) or 7 days at room temperature (15-25°C) if protected from light. Solutions for intravesical use should be used immediately after preparation. Do not freeze.