Mitomycin

What it is and how it works

Mechanism class: Alkylating Activity

Indications

INDICATIONS AND USAGE Mitomycin for Injection, USP 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Mitomycin should be given intravenously only, using care to avoid extravasation of the compound. If extravasation occurs, cellulitis, ulceration, and slough may result. Each Single-Dose vial contains either mitomycin 5 mg and mannitol 10 mg or mitomycin 20 mg and mannitol 40 mg. To administer, add Sterile Water for Injection, 10 mL or 40 mL respectively. Shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until solution is obtained.

Contraindications

CONTRAINDICATIONS Mitomycin is contraindicated in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past. Mitomycin is contraindicated in patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.

Warnings and precautions

WARNINGS Patients being treated with mitomycin must be observed carefully and frequently during and after therapy. The use of mitomycin results in a high incidence of bone marrow suppression, particularly thrombocytopenia and leukopenia. Therefore, the following studies should be obtained repeatedly during therapy and for at least eight weeks following therapy: platelet count, white blood cell count, differential, and hemoglobin.

Pregnancy

Usage in Pregnancy Safe use of mitomycin in pregnant women has not been established. Teratological changes have been noted in animal studies. The effect of mitomycin on fertility is unknown.

Storage and supply

Storage Store dry powder at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F). Protect from light. Avoid excessive heat, over 40°C (104°F). Protect reconstituted solution from light. Store solution under refrigeration 2° to 8°C (36° to 46°F), discard after 14 days. If unrefrigerated, discard after 7 days.

Source: Mitomycin (Mitomycin) — US FDA prescribing information, 2023-05-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.