Mitomycine Substipharm (Mitomycin)

Mitomycin is employed in chemotherapy regimens targeting malignant solid tumours.

• Bladder cancer: used to eradicate residual tumour cells after transurethral resection, improving local control.
• Gastric cancer: administered as part of combination therapy to reduce tumour burden and enhance surgical outcomes.
• Pancreatic cancer: incorporated in multi‑drug protocols to inhibit tumour growth and prolong survival.
• Colorectal cancer: used in adjuvant settings to prevent disease recurrence following resection.
• Head and neck cancers: applied in combination regimens to increase response rates and facilitate organ preservation.

• Mitomycin acts as a DNA cross‑linking alkylating agent. After intracellular activation, it forms covalent bonds between adjacent DNA strands, preventing strand separation during replication. This inhibition of DNA synthesis leads to cell cycle arrest and apoptosis, particularly in rapidly proliferating cancer cells. The drug preferentially accumulates in hypoxic tumour regions, where enzymatic reduction enhances its cytotoxic potential, and its effects are not readily reversible.

Mitomycin may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

• Nausea and vomiting: gastrointestinal upset commonly reported during treatment.
• Myelosuppression: reduced white blood cells, red cells, and platelets leading to anemia or infection risk.
• Fatigue: persistent tiredness affecting daily activities.
• Alopecia: temporary hair loss observed in many patients.
• Mucositis: inflammation of the mouth and gastrointestinal lining.
• Diarrhea: loose stools that may require supportive care.

Serious or Rare Side Effects

• Bone marrow failure: severe pancytopenia requiring transfusion or growth factor support.
• Pulmonary toxicity: interstitial pneumonitis or fibrosis presenting with cough and dyspnea.
• Hemolytic‑uremic syndrome: acute kidney injury with hemolysis and low platelets.
• Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
• Renal toxicity: acute renal failure especially with high cumulative doses.
• Thrombotic microangiopathy: rare clotting disorder affecting small vessels.

When using Mitomycin, clinicians should observe several safety measures to minimise risks.

• Monitor blood counts: perform regular complete blood count tests to detect myelosuppression early.
• Assess renal function: evaluate serum creatinine and urine output before and during therapy.
• Evaluate pulmonary status: obtain baseline lung function and watch for respiratory symptoms.
• Avoid in hypersensitivity: discontinue if allergic reactions such as rash or anaphylaxis occur.
• Use contraception: advise patients of reproductive potential to employ effective birth control during treatment and for a defined period after.
• Store below 25°C: keep in the original container, protect from moisture and light.

Mitomycin can interact with other medicines, altering its efficacy or toxicity.

Major Interactions (Avoid)

• Concurrent alkylating agents: combined use markedly increases risk of severe myelosuppression.
• High‑dose radiation therapy: may potentiate tissue damage and enhance pulmonary toxicity.
• Certain antibiotics (e.g., aminoglycosides): can exacerbate nephrotoxicity when given together.

Moderate Interactions (Monitor Closely)

• NSAIDs: may increase risk of gastrointestinal bleeding and renal impairment.
• Diuretics: can affect fluid balance and kidney function, requiring dose adjustments.
• CYP450 modulators: although limited metabolism, strong inducers or inhibitors may slightly modify drug clearance.