Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 5mg
- 20mg
- 40mg
Stomach Cancer, Pancreas Cancer
Anal Carcinoma (Off-label)
10 mg/m² as IV bolus days 1-29; not to exceed 20 mg/dose
Dosage Modification
for SI units: count in US units x10^6/L
Full dose if
- Leukocytes >3000/mm³
- Platelets >75 x 10^3/mm³
Give 70% if
- Leukocytes: 2000-2999/mm³
- Platelets: 25-74.999 x 10^3/mm³
Give 50% if
- Leukocytes <2000/mm³
- Platelets <25 x 10^3/mm³
Renal Impairment
Serum creatinine >1.7 mg/dL: Avoid use
CrCl <10 mL/min: Decrease dose by 25%
CAPD: Decrease dose by 25%
Monitor
CBC, LFTs, renal function
Do not repeat dose until WBC >4000/mm³ and Plts >100,000/mm³
Dosing Considerations
Always use in combination with other antineoplastics
Discontinue if progression continues after 2 courses
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (9)
- bacitracin
mitomycin and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs
- deferiprone
deferiprone, mitomycin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- erdafitinib
erdafitinib will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.
- lasmiditan
lasmiditan increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of mitomycin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, mitomycin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- sotorasib
sotorasib will decrease the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.
- tepotinib
tepotinib will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.
- voxelotor
mitomycin will decrease the level or effect of voxelotor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor is primarily metabolized by CYP3A4. Avoid coadministration with moderate or strong CYP3A4 inducers. If unable to avoid coadministration, increase voxelotor dose (see Dosage Modifications).
Monitor Closely (33)
- acalabrutinib
acalabrutinib, mitomycin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- berotralstat
berotralstat will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.
- bosutinib
bosutinib increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- cholera vaccine
mitomycin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- crizotinib
crizotinib increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- dengue vaccine
mitomycin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
mitomycin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- elagolix
elagolix will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- eliglustat
eliglustat increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.
- fingolimod
mitomycin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- fostamatinib
fostamatinib will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp substrates. Monitor for toxicities of the P-gp substrate drug that may require dosage reduction when given concurrently with fostamatinib.
- glecaprevir/pibrentasvir
glecaprevir/pibrentasvir will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- hydroxyurea
mitomycin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- istradefylline
istradefylline will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.
- ivacaftor
ivacaftor increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Ivacaftor and its M1 metabolite has the potential to inhibit P-gp; may significantly increase systemic exposure to sensitive P-gp substrates with a narrow therapeutic index.
- lomitapide
lomitapide increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.
- lonafarnib
lonafarnib will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.
- ofatumumab SC
ofatumumab SC, mitomycin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- ponatinib
ponatinib increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- sarecycline
sarecycline will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.
- siponimod
siponimod and mitomycin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
mitomycin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- stiripentol
stiripentol will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.
- tenofovir DF
mitomycin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
mitomycin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - trastuzumab
trastuzumab, mitomycin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, mitomycin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- tucatinib
tucatinib will increase the level or effect of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.
- vemurafenib
vemurafenib increases levels of mitomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- vinblastine
vinblastine increases toxicity of mitomycin by unknown mechanism. Use Caution/Monitor. Acute shortness of breath and severe bronchospasm have occurred following use of vinca alkaloids in patients who had previously or simultaneously received mitomycin. .
- vincristine
vincristine increases toxicity of mitomycin by unknown mechanism. Use Caution/Monitor. Risk of severe bronchospasm and dyspnea. D/C mitomycin 2 wks prior to vinblastine Tx.
- vincristine liposomal
vincristine liposomal increases toxicity of mitomycin by unknown mechanism. Use Caution/Monitor. Risk of severe bronchospasm and dyspnea. D/C mitomycin 2 wks prior to vinblastine Tx.
- vinorelbine
mitomycin, vinorelbine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Acute shortness of breath and severe bronchospasm have occurred following use of vinca alkaloids in patients who had previously or simultaneously received mitomycin. .
- zidovudine
mitomycin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
Minor (0)
Adverse Effects
>10%
Hemolytic uremic syndrome (≤15%)
Myelosuppression (64%)
Nausea/vomiting (14%)
Fever (14%)
1-10%
Stomatitis (4%)
Increased serum creatinine (2%)
Mucous membrane toxicity (4%)
Frequency Not Defined
Fatigue
Pulmonary toxicity
Dyspnea
Cystitis
Interstitial fibrosis
Nephrotoxicity
Amenorrhea
Alopecia
Warnings
Black Box Warnings
The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to manage complications
Bone marrow suppression, notably thrombocytopenia and leucopenia, may contribute to overwhelming infections in an already compromised patient
Hemolytic uremic syndrome may occur with monotherapy or combination therapy and usually occurs with doses >60 mg. Blood product transfusion may exacerbate symptoms
Contraindications
Hypersensitivity
Thrombocytopenia, coagulation disorders, bleeding diathesis
Cautions
Vesicant
Avoid use in renal impairment (SCr >1.7 mg/dL [150.3 umol/L])
Chicken pox, recent
Bladder fibrosis/contraction reported
Herpes zoster
Acute respiratory distress syndrome reported when used in combination with other types of chemotherapy maintained at FIO2 concentrations >50% preoperatively
Avoid pregnancy
Increased prevalence of Heart Failure observed when used in conjunction with anthracyclines
Pregnancy & Lactation
Pregnancy Category: D
Lactation: Not known if excreted in breast milk, do not nurse
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Crosslinks DNA, preventing replication and transcription
Pharmacokinetics
Half-life: 48 min
Vd: 16-56 L/m²
Metabolism: Liver
Clearance: 201-810 mL/min/m²
Excretion: Urine (10%)
Administration
IV Incompatibilities
Solution: D5W
Additive: bleomycin
Y-site: aztreonam, cefepime, etoposide PO4, filgrastim, gemcitabine, piperacillin/tazobactam, sargramostim, topotecan, vinorelbine
IV Compatibilities
Solution: LR, NS
Additive: dexamethasone Na-phosphate, heparin, hydrocortisone Na-succinate
Syringe: bleomycin, cisplatin, cyclophosphamide, doxorubicin, droperidol, fluorouracil, furosemide, heparin, leucovorin, methotrexate, metoclopramide, vinblastine, vincristine
Y-site: amifostine, bleomycin, cisplatin, cyclophosphamide, doxorubicin, droperidol, fluorouracil, furosemide, granisetron, heparin, leucovorin, melphalan, methotrexate, metoclopramide, ondansetron, teniposide, thiotepa, vinblastine, vincristine
IV Preparation
Reconstitute with SWI to a concentration of 0.5 mg/mL
Standard dilution
- IV push: dose/syringe (concentration is 0.5 mg/mL); maximum syringe size for IVP is a 30 mL syringe & syringe should be <75% full
- IVPB: dose/100 mL NS
IV Administration
Vesicant
Administer slow IV push by central line only
Flush with 5-10 mL of IV solution before & after drug administration
IVPB infusion should be closely monitored for adequate vein patency
Extravasation Management
Frequently causes necrosis
Plastic surgeon may be required
Storage
Store intact vials of lyophilized powder at RT
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Mutamycin intravenous - | 40 mg vial |  | |
| Mutamycin intravenous - | 20 mg vial |  | |
| Mutamycin intravenous - | 5 mg vial |  | |
| mitomycin intravenous - | 40 mg vial |  | |
| mitomycin intravenous - | 20 mg vial |  | |
| mitomycin intravenous - | 5 mg vial |  | |
| mitomycin intravenous - | 40 mg vial |  | |
| mitomycin intravenous - | 40 mg vial |  | |
| mitomycin intravenous - | 20 mg vial |  | |
| mitomycin intravenous - | 40 mg vial |  | |
| mitomycin intravenous - | 5 mg vial |  | |
| mitomycin intravenous - | 20 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
mitomycin ophthalmic (eye)
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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