Mitomycine Substipharm (Mitomycin)

Mitomycin is used as an antineoplastic agent that interferes with DNA synthesis in malignant cells.

• Bladder cancer: helps control tumour growth and may be used after surgery or as part of combination therapy.
• Gastric cancer: contributes to tumour regression when administered systemically.
• Pancreatic cancer: used in advanced disease to slow progression.
• Breast cancer: employed in certain regimens to enhance cytotoxic effect on tumour cells.

• Mitomycin acts as an alkylating agent that undergoes enzymatic reduction within cells to generate reactive intermediates. These intermediates form covalent cross‑links between DNA strands, preventing DNA replication and transcription, ultimately leading to apoptosis of rapidly dividing cancer cells.

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

Common Side Effects

• Nausea: mild to moderate gastrointestinal upset.
• Myelosuppression: reduced white blood cells, platelets, and red cells.
• Alopecia: temporary hair loss.
• Fatigue: generalized tiredness.
• Diarrhoea: loose stools, sometimes requiring supportive care.
• Vomiting: occasional emesis.

Serious or Rare Side Effects

• Severe bone‑marrow suppression: risk of infection and bleeding.
• Pulmonary toxicity: interstitial pneumonitis or fibrosis.
• Hemolytic‑uremic syndrome: acute kidney injury with haemolysis.
• Severe allergic reactions: anaphylaxis or serum sickness.
• Renal toxicity: impaired kidney function.
• Cardiotoxicity: rare myocardial injury.

Before initiating therapy with Mitomycin, several safety measures should be considered.

• Monitor blood counts: perform regular CBC to detect myelosuppression early.
• Assess renal function: check serum creatinine and eGFR prior to each dose.
• Evaluate hepatic function: liver enzymes should be within acceptable limits.
• Avoid in known hypersensitivity: discontinue if allergic reactions occur.
• Use caution in pregnancy: potential fetal risk, discuss with specialist.
• Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Mitomycin can interact with other medicines, influencing efficacy or toxicity.

Major Interactions (Avoid)

• Concurrent high‑dose radiation therapy: increased tissue damage.
• Other myelosuppressive agents (e.g., cyclophosphamide): heightened bone‑marrow suppression.
• Nephrotoxic drugs (e.g., cisplatin): amplified renal toxicity.

Moderate Interactions (Monitor Closely)

• NSAIDs: may worsen gastrointestinal irritation.
• Anticoagulants: increased bleeding risk due to thrombocytopenia.
• Diuretics: potential electrolyte disturbances.
• Strong CYP inducers: may reduce plasma levels, though effect is limited.