pharmacopeia
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/api/v1/drug/mitomycin

Boxed warning

Mitomycin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin (see WARNINGS and ADVERSE REACTIONS sections). Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs, however, most cases occur at doses ≥60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome. The incidence of the syndrome has not been defined.

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Alkylating Activity; Nucleic Acid Synthesis Inhibitors.

Nucleic Acid Synthesis

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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 mitomycin 40 mg and mannitol 80 mg. To administer, add Sterile Water for Injection, 80 mL. Shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until solution is obtained. After full hematological recovery (see guide to dosage adjustment) from any previous chemotherapy, the following dosage schedule may be used at 6 to 8 week intervals: 20 mg/m 2 intravenously as a single dose via a functioning intravenous catheter. Because of cumulative myelosuppression, patients should be fully re-evaluated after each course of mitomycin, and the dose reduced if the patient has experienced any toxicities. Doses greater than 20 mg/m 2 have not been shown to be more effective, and are more toxic than lower doses. The following schedule is suggested as a guide to dosage adjustment: Nadir After Prior Dose Leukocytes /mm 3 Platelets / mm 3 Percentage of Prior Dose to be given >4000 >100,000 100% 3000 - 3999 75,000 - 99,999 100% 2000 - 2999 25,000 - 74,999 70% <2000 <25,000 50% No repeat dosage should be given until leukocyte count has returned to 4000/mm 3 and a platelet count to 100,000/mm 3 .

Warnings & precautions

Sourced from openFDA

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. The occurrence of a platelet count below 100,000/mm 3 or a WBC below 4,000/mm 3 or a progressive decline in either is an indication to withhold further therapy until blood counts have recovered above these levels. Patients should be advised of the potential toxicity of this drug, particularly bone marrow suppression. Deaths have been reported due to septicemia as a result of leukopenia due to the drug. Patients receiving mitomycin should be observed for evidence of renal toxicity. Mitomycin should not be given to patients with a serum creatinine greater than 1.7 mg percent. 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.

Adverse reactions

Sourced from openFDA

Bone Marrow Toxicity This was the most common and most serious toxicity, occurring in 605 of 937 patients (64.4%). Thrombocytopenia and/or leukopenia may occur anytime within 8 weeks after onset of therapy with an average time of 4 weeks. Recovery after cessation of therapy was within 10 weeks. About 25% of the leukopenic or thrombocytopenic episodes did not recover. Mitomycin produces cumulative myelosuppression. Integument and Mucous Membrane Toxicity This has occurred in approximately 4% of patients treated with mitomycin. Cellulitis at the injection site has been reported and is occasionally severe. Stomatitis and alopecia also occur frequently. Rashes are rarely reported. The most important dermatological problem with this drug, however, is the necrosis and consequent sloughing of tissue which results if the drug is extravasated during injection. Extravasation may occur with or without an accompanying stinging or burning sensation and even if there is adequate blood return when the injection needle is aspirated. There have been reports of delayed erythema and/or ulceration occurring either at or distant from the injection site, weeks to months after mitomycin, even when no obvious evidence of extravasation was observed during administration. Skin grafting has been required in some of the cases. Elderly patients may be more susceptible than younger patients to injection site reactions (see PRECAUTIONS: Geriatric Use ). Renal Toxicity 2% of 1,281 patients demonstrated a statistically significant rise in creatinine.

Use in specific populations

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Apr 19, 1995ANDAANDA064117Hikma
  • Apr 30, 1998ANDAANDA064144Accord Hlthcare
  • Feb 7, 2012NDANDA022572Glaukos
  • Oct 13, 2017ANDAANDA203386Rk Pharma
  • Oct 13, 2017ANDAANDA202670Rk Pharma
  • Apr 15, 2020NDANDA211728Urogen Pharma
  • Oct 20, 2021ANDAANDA215687Gland
  • Jun 12, 2025NDANDA215793Urogen Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,204 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use37512%
  2. 2Nausea1635.1%
  3. 3Diarrhoea1504.7%
  4. 4Fatigue1183.7%
  5. 5Drug Ineffective1103.4%
  6. 6Thrombocytopenia1103.4%
  7. 7Neutropenia1073.3%
  8. 8Rash1073.3%
  9. 9Vomiting1063.3%
  10. 10Pancytopenia1013.2%
  11. 11Pyrexia993.1%
  12. 12Disease Progression983.1%
  13. 13Death872.7%
  14. 14Pain812.5%
  15. 15Leukopenia762.4%

Literature

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Recent PubMed references pinned to Mitomycin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 408 ClinicalTrials.gov registrations naming Mitomycin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Mitomycin work?
Mechanism-of-action classes: Alkylating Activity; Nucleic Acid Synthesis Inhibitors.
What is Mitomycin used for?
According to FDA labeling, Mitomycin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Mitomycin?
Mitomycin is classified as Other cytotoxic antibiotics, Alkylating Drug, Alkylating Activity, Nucleic Acid Synthesis Inhibitors, Decreased DNA Integrity, Decreased RNA Integrity.
What are the brand names for Mitomycin?
Mitomycin is marketed under brand names including Jelmyto, Mitosol, Mutamycin, Zusduri.
What are the contraindications for Mitomycin?
Mitomycin labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for mitomycin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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