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Mitomycin (intravenous and intravesical) (systemic): Drug information

Mitomycin (intravenous and intravesical) (systemic): Drug information
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For additional information see "Mitomycin (intravenous and intravesical) (systemic): Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Experienced physician:

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:

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.

Hemolytic uremic syndrome:

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 greater than or equal to 60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome. The incidence of the syndrome has not been defined.

Brand Names: US
  • Mutamycin
Pharmacologic Category
  • Antineoplastic Agent, Antibiotic
Dosing: Adult

Dosage guidance:

Safety: Do NOT substitute mitomycin injection for mitomycin (ureteral gel) or mitomycin (ophthalmic) or vice versa; the products are different and are NOT interchangeable.

Clinical considerations: Refer to the protocol or institutional guidance for additional details of off-label dosing.

Anal carcinoma

Anal carcinoma (off-label use): IV: 10 mg/m2 on days 1 and 29 (maximum: 20 mg/dose) in combination with fluorouracil and radiation therapy (Ref) or 12 mg/m2 on day 1 only (maximum dose: 20 mg) in combination with fluorouracil and radiation therapy (Ref) or 15 mg/m2 on day 1 only in combination with fluorouracil and radiation therapy (Ref) or 10 mg/m2 on day 1 (maximum dose: 15 mg) in combination with capecitabine and radiation therapy (Ref) or 12 mg/m2 on day 1 (maximum dose: 20 mg) in combination with capecitabine and radiation therapy (Ref) or 15 mg/m2 on day 1 only in combination with capecitabine and radiation therapy (Ref).

Bladder cancer

Bladder cancer (off-label use):

Muscle invasive: IV (mitomycin injection solution): 12 mg/m2 on day 1 (in combination with fluorouracil and radiation) (Ref).

Nonmuscle invasive (off-label route): Intravesicular instillation of mitomycin injection solution:

Low risk of recurrence (uncomplicated): Intravesical ar instillation: 40 mg as a single dose postoperatively; retain in bladder for 1 to 2 hours (Ref).

Increased risk of recurrence: Intravesical ar instillation: 20 mg weekly for 6 weeks, followed by 20 mg monthly for 3 years; retain in bladder for 1 to 2 hours (Ref) or 40 mg weekly for 6 weeks (with urine alkalinization and decreased urine volume to increase drug concentration); retain in bladder for 2 hours (Ref).

Cervical cancer, recurrent or metastatic

Cervical cancer, recurrent or metastatic (off-label use; based on limited data): IV: 6 mg/m2 on day 1 once every 4 weeks (in combination with cisplatin) for a minimum of 2 cycles (preferably 9 cycles) (Ref).

Gastric cancer

Gastric cancer: Note: Although approved for the treatment of disseminated adenocarcinoma of the stomach and as palliative treatment, mitomycin use has been replaced by other/more contemporary treatment modalities.

IV: 20 mg/m2 once every 6 to 8 weeks; discontinue if disease progression continues after 2 courses of therapy.

Off-label dosing: IV: 7 mg/m2 (maximum dose: 14 mg) once every 6 weeks for 4 cycles (in combination with cisplatin and fluorouracil) (Ref).

Hepatocellular cancer, chemoembolization

Hepatocellular cancer, chemoembolization (off-label use): Conventional transcatheter arterial chemoembolization (cTACE): Intra-arterial: 10 mg as a single dose via intra-arterial injection; based on clinical judgement, may repeat at 6 to 8 week intervals (Ref) or 8 mg/m2 as a single dose via intra-arterial injection every 4 weeks for at least 2 doses (Ref). Refer to protocol and institutional policies for additional dosing/administration details.

Pancreatic cancer

Pancreatic cancer: Note: Although approved for the treatment of disseminated adenocarcinoma of the stomach and as palliative treatment, mitomycin use has been replaced by other/more contemporary treatment modalities.

IV: 20 mg/m2 once every 6 to 8 weeks; discontinue if disease progression continues after 2 courses of therapy.

Vulvar cancer, advanced

Vulvar cancer, advanced (off-label use; based on limited data): IV: 15 mg/m2 on day 1 every 14 days for 2 cycles (in combination with concomitant radiation and fluorouracil) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The manufacturer’s labeling states to avoid use in patients with serum creatinine >1.7 mg/dL, although no other dosage modifications are provided. The following adjustments have been recommended:

Krens 2019:

GFR ≥30 mL/minute: No need for dose adjustment is expected.

GFR <30 mL/minute: Use is not recommended.

Hemodialysis: Use is not recommended.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, the following adjustments have been recommended:

Mild or moderate impairment: No need for dose adjustment is expected (Ref).

Severe impairment: Consider reducing dose to 50% of the original dose (Ref).

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 : Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref). Note: Some protocols may have maximum recommended doses.

Dosing: Adjustment for Toxicity: Adult

Note: Other concomitant anticancer medications may also require dosage adjustment.

Mitomycin Recommended Dosage Modifications for Adverse Reactionsa

Adverse reaction

Severity

Mitomycin dosage modification

a Manufacturer’s labeling.

Hematologic toxicity (based on nadir at prior dose)

Leukopenia

Leukocytes 3,000 to <4,000/mm3

Withhold mitomycin until leukocytes ≥4,000/mm3, then may resume at 100% of prior dose in subsequent cycles.

Leukocytes 2,000 to <3,000/mm3

Withhold mitomycin until leukocytes ≥4,000/mm3; for subsequent cycles, reduce mitomycin dose to 70% of prior dose.

Leukocytes <2,000/mm3

Withhold mitomycin until leukocytes ≥4,000/mm3; for subsequent cycles, reduce mitomycin dose to 50% of prior dose.

Thrombocytopenia

Platelets 75,000 to <100,000/mm3

Withhold mitomycin until platelets ≥100,000/mm3, then may resume 100% of prior dose in subsequent cycles.

Platelets 25,000 to <75,000/mm3

Withhold mitomycin until platelets ≥100,000/mm3; for subsequent cycles, reduce mitomycin dose to 70% of prior dose.

Platelets <25,000/mm3

Withhold mitomycin until platelets ≥100,000/mm3; for subsequent cycles, reduce mitomycin dose to 50% of prior dose.

Nonhematologic toxicity

Pulmonary toxicity

Any

Discontinue mitomycin if pulmonary toxicity occurs and other potential etiologies have been ruled out.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Anorexia (≤14%), nausea (≤14%), vomiting (≤14%)

Hematologic & oncologic: Bone marrow depression (64%; including leukopenia, thrombocytopenia)

Miscellaneous: Fever (≤14%)

1% to 10%:

Dermatologic: Dermatologic disorder (4%; including alopecia, cellulitis at injection site, dermal ulcer, erythema of skin, skin rash, stomatitis)

Renal: Increased serum creatinine (2%)

Postmarketing:

Cardiovascular: Heart failure

Hematologic & oncologic: Thrombotic microangiopathy (including hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura) (Blake-Haskins 2011, Khaja 2022, Nishiyama 2001)

Nervous system: Asthenia, malaise

Respiratory: Pulmonary toxicity (including dry cough, dyspnea, interstitial pneumonitis pulmonary infiltrates, pulmonary veno-occlusive disease) (Kunadu 2021; Saif 2010)

Contraindications

Hypersensitivity to mitomycin or any component of the formulation; thrombocytopenia; coagulation disorders, or other increased bleeding tendency.

Warnings/Precautions

Concerns related to adverse effects:

• Bladder fibrosis/contraction: Bladder fibrosis/contraction has been reported with intravesical administration (unlabeled administration route).

• Bone marrow suppression: Bone marrow suppression (thrombocytopenia and leukopenia) is common and may be severe and/or contribute to infections. WBC and platelet nadir usually occurs at 4 weeks, although may occur at up to 8 weeks; recovery occurs within 10 weeks. Fatalities due to sepsis have been reported. Myelosuppression is dose-limiting, delayed in onset, and cumulative.

• Extravasation: Mitomycin is a potent vesicant; ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation. May cause necrosis and tissue sloughing; delayed erythema and/or ulceration have been reported.

• Heart failure: In a scientific statement from the American Heart Association, mitomycin has been determined to be an agent that may either cause reversible direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: moderate) (AHA [Page 2016]).

• Hemolytic-uremic syndrome: Hemolytic-uremic syndrome (HUS) has been reported (incidence not defined); condition usually involves microangiopathic hemolytic anemia (hematocrit ≤25%), thrombocytopenia (≤100,000/mm3), and irreversible renal failure (serum creatinine ≥1.6 mg/dL). HUS may occur at any time (either with single agent or combination therapy), is generally associated with single doses ≥60 mg, and HUS symptoms may be exacerbated by blood transfusion. Other less common effects may include pulmonary edema, neurologic abnormalities, and hypertension. A high mortality from HUS has been reported.

• Pulmonary toxicity: Cases of acute respiratory distress syndrome (ARDS) have been reported in patients receiving mitomycin in combination with other chemotherapy who were maintained at FIO2 concentrations >50% perioperatively; use caution to provide only enough oxygen to maintain adequate arterial saturation and avoid overhydration. Pulmonary toxicity has also been reported as dyspnea with nonproductive cough and appearance of pulmonary infiltrates on radiograph.

Concurrent drug therapy issues:

• Vinca alkaloids: Shortness of breath and bronchospasm have been reported in patients receiving vinca alkaloids in combination with mitomycin or who received mitomycin previously; this acute respiratory distress has occurred within minutes to hours following the vinca alkaloid; may be managed with bronchodilators, steroids and/or oxygen.

Other warnings/precautions:

• Product selection: Mitomycin is available as mitomycin for injection, mitomycin (ophthalmic), and mitomycin (ureteral gel); the products are different and are NOT interchangeable. Verify product label prior to reconstitution and administration to prevent medication errors.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Intravenous:

Mutamycin: 5 mg (1 ea); 20 mg (1 ea [DSC]); 40 mg (1 ea)

Generic: 5 mg (1 ea); 20 mg (1 ea); 40 mg (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Generic: 5 mg (1 ea); 20 mg (1 ea); 40 mg (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (reconstituted) (mitoMYcin Intravenous)

5 mg (per each): $110.63 - $291.92

20 mg (per each): $132.00 - $758.40

40 mg (per each): $264.00 - $1,516.80

Solution (reconstituted) (Mutamycin Intravenous)

5 mg (per each): $423.87

40 mg (per each): $2,202.35

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection:

Generic: 20 mg (1 ea)

Solution Reconstituted, Intravenous:

Generic: 20 mg (1 ea)

Administration: Adult

IV: Administer by slow IV push/bolus via a freely-running saline infusion. Consider using a central venous catheter.

Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Initiate dimethyl sulfate (DMSO) antidote. Apply dry cold compress for 20 minutes 4 times/day for 1 to 2 days (Ref).

DMSO: Apply topically to a region covering twice the affected area every 8 hours for 7 days; begin within 10 minutes of extravasation; do not cover with a dressing (Ref).

Intravesicular administration of mitomycin injection solution (off-label use/route): Instill into bladder and retain for 1 to 2 hours (Ref); rotate patient every 15 to 30 minutes.

Intra-arterial: Transcatheter arterial chemoembolization (TACE; off-label use): For conventional TACE, mitomycin was administered with lipiodol and contrast media followed by particle embolization with an embolic agent (Ref) or followed by starch microspheres for vessel occlusion (Ref). IV antibiotics were administered prior to the procedure and embolic material was injected through the catheter until hemostasis was achieved (Ref). Refer to protocol and institutional policies for additional administration details.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Use: Labeled Indications

Gastric cancer: Treatment of disseminated adenocarcinoma of the stomach (in combination with other chemotherapy agents) and as palliative treatment when other modalities have failed.

Note: Although approved for the treatment of disseminated adenocarcinoma of the stomach and as palliative treatment, mitomycin use in the management of gastric cancer has been replaced by other/more contemporary treatment modalities.

Pancreatic cancer: Treatment of disseminated adenocarcinoma of the pancreas (in combination with other chemotherapy agents) and as palliative treatment when other modalities have failed.

Note: Although approved for the treatment of disseminated adenocarcinoma of the pancreas and as palliative treatment, mitomycin use in the management of pancreatic cancer has been replaced by other/more contemporary treatment modalities.

Limitations of use: Not recommended for single-agent primary therapy or to replace appropriate surgery and/or radiotherapy in the treatment of these conditions.

Use: Off-Label: Adult

Anal cancer; Bladder cancer; Cervical cancer, recurrent or metastatic; Hepatocellular carcinoma (chemoembolization); Vulvar cancer, advanced

Medication Safety Issues
Sound-alike/look-alike issues:

MitoMYcin (Systemic) may be confused with MitoMYcin (Ophthalmic), MitoMYcin (ureteral gel), mitotane, mitoXANTRONE

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Other safety concerns:

MitoMYcin is available as mitoMYcin for injection, mitoMycin (ophthalmic), and mitoMYcin (ureteral gel); the products are different and are NOT interchangeable. Verify product label prior to reconstitution and administration to prevent medication errors.

Metabolism/Transport Effects

Substrate of P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Antineoplastic Agents (Vinca Alkaloids): May increase adverse/toxic effects of MitoMYcin (Systemic). Specifically, the risk of pulmonary toxicity may be increased. Risk C: Monitor

Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of BCG Products. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Lenograstim: Antineoplastic Agents may decrease therapeutic effects of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Lipegfilgrastim: Antineoplastic Agents may decrease therapeutic effects of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Palifermin: May increase adverse/toxic effects of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider Therapy Modification

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Mitomycin is expected to have a low risk of treatment-related azoospermia and male infertility (ESMO [Lambertini 2020]).

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies.

Breastfeeding Considerations

It is not known if mitomycin is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.

Monitoring Parameters

Monitor CBC with differential (repeatedly during therapy and for ≥8 weeks following therapy); serum creatinine; pulmonary function tests. Monitor for signs/symptoms of HUS, pulmonary toxicity, and infection. Monitor infusion site.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Mitomycin alkylates DNA to produce DNA cross-linking (primarily with guanine and cytosine pairs) and inhibits DNA and RNA synthesis. Mitomycin is not cell cycle specific but has its maximum effect against cells in late G and early S phases (Perry 2012).

Pharmacokinetics (Adult Data Unless Noted)

Metabolism: Primarily hepatic

Half-life elimination: 17 minutes (30 mg dose)

Excretion: Feces (primarily [Perry 2012]); Urine

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Asomutan | Crisofimina | Maximitom | Mitokebir | Mitomicina | Mitomicina C | Mitomicina Gobbi | Mitomicina martian | Mitomicina microsules | Mitomicina-c filaxis | Mitomycin c bristol | Mitotie | Ronzine | Vetio;
  • (AT) Austria: Mitomycin c kyowa | Mitomycin medac;
  • (AU) Australia: Mitocin | Mitomycin omegapharm;
  • (BE) Belgium: Mitomycin c kyowa;
  • (BG) Bulgaria: Mitomycin C;
  • (BR) Brazil: Mitocin;
  • (CH) Switzerland: Mitem;
  • (CL) Chile: Fatrix | Metomit | Mitomicina;
  • (CN) China: Mitomycin-c;
  • (CO) Colombia: Al phamycina | Mitolem | Mitomicina | Mixandex | Mutamycin | Riptan;
  • (CZ) Czech Republic: Mitomycin accord | Mitomycin C | Mitomycin medac;
  • (DE) Germany: Ametycine | Mitem | Mito | Mito Medac | Mitomycin accord | Mitomycin AKO | Mitomycin hexal | Mitomycin Teva | Urocin;
  • (EC) Ecuador: Maximitom | Mitomicina | Mitomicina kemex | Mitotie;
  • (EE) Estonia: Mito | Mitomycin accord | Mitomycin medac | Mitomycin-c kyowa | Mutamycin;
  • (EG) Egypt: Mutamycin;
  • (ES) Spain: Mitomicina accord | Mitomicina medac | Mitomycin C;
  • (FI) Finland: Mitomycin accord | Mitomycin medac | Mitomycin Substipharm | Mitostat | Mutamycin;
  • (FR) France: Ametycine | Mitomycin medac | Mitomycine accord | Mitomycine Dci | Mitomycine substipharm;
  • (GB) United Kingdom: Mitocin | Mitomycin c kyowa | Mitomycin medac;
  • (HK) Hong Kong: Mitomycin c kyowa;
  • (HU) Hungary: Mitomycin c kyowa | Mitomycin medac;
  • (ID) Indonesia: Mitomycin-c;
  • (IE) Ireland: Mitomycin c kyowa;
  • (IL) Israel: Mitomycin C;
  • (IN) India: Almito | Lyomit | Mito | Mitomycin c kyowa | Mitonco;
  • (IT) Italy: Mitomicina medac | Mitomycin C | Miturox;
  • (KR) Korea, Republic of: Mitomycin C | Mitomycin C koreaunited | Mitomycin c kyowa | Mitomycin-c;
  • (LB) Lebanon: Mitomycin C;
  • (LT) Lithuania: Mitomycin C | Mitomycin medac | Mutamycin;
  • (LV) Latvia: Mito | Mitomycin C | Mitomycin medac;
  • (MX) Mexico: Kenomix | Mitolem | Mitomicina | Mitotie | Mixandex;
  • (MY) Malaysia: Mito | Mitomycin c kyowa;
  • (NL) Netherlands: Mitomycin c kyowa | Mitomycin-c kyowa | Mitomycine accord | Mitomycine medac;
  • (NO) Norway: Mito | Mitocin | Mitomycin C | Mitomycin medac | Mutamycin;
  • (NZ) New Zealand: Arrow Mitomycin C | Mitomycin c kyowa;
  • (PE) Peru: Mitomicina | Mitomycin C;
  • (PH) Philippines: Mitomycin C | Mitomycin-c kyowa;
  • (PK) Pakistan: Mitocin;
  • (PL) Poland: Lyomit | Misintu | Mito | Mito Medac | Mitomycin accord | Mitomycin C;
  • (PR) Puerto Rico: Jelmyto | Mitosol | Mutamycin;
  • (PT) Portugal: Mitomicina | Mitomicina C Kyowa | Mitomicina medac;
  • (PY) Paraguay: Maximiton | Mitokebir | Mitomicina c filaxis | Mitomicina c microsules | Mitomicina c tuteur | Mitomicina fapasa | Mitomicina farmaco uruguayo | Mitomicina martian | Mitomicina sidus | Mitotie;
  • (QA) Qatar: Misintu | Mitomycin-C Kyowa;
  • (RU) Russian Federation: Mitomycin C | Mitomycin deco | Mutamycin | Vero mitomycin;
  • (SA) Saudi Arabia: Mitomycin medac;
  • (SE) Sweden: Mitomycin medac | Mitomycin Substipharm;
  • (SG) Singapore: Mitomycin C;
  • (SI) Slovenia: Mitem | Mitomicin medac | Mitomycin c aesica | Mitomycin c inbsa | Mitomycin c kyowa | Mutamycin;
  • (SK) Slovakia: Mitomycin C | Mitomycin medac;
  • (TH) Thailand: Mitomycin-c kyowa | Mitonco | Vesimycin;
  • (TN) Tunisia: Ametycine;
  • (TR) Turkey: Misintu | Mitomycin C;
  • (TW) Taiwan: Mitomycin-c | Mitonco | Vesimycin;
  • (UA) Ukraine: Mitolem | Mitomycin c kyowa | Mitomycin Mili;
  • (UY) Uruguay: Mitomicina C | Mitomicina c filaxis | Mitomicina delta Farma | Mutamycin;
  • (ZA) South Africa: Mitomycin C
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