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Mitomycin Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 21, 2020.

For the Consumer

Applies to mitomycin: intravenous powder for solution

Warning

Intravenous route (Powder for Solution)

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. 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.

Side effects requiring immediate medical attention

Along with its needed effects, mitomycin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way cancer medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking mitomycin:

Less common

  • Black, tarry stools
  • blood in urine or stools
  • cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on skin
  • unusual bleeding or bruising

Rare

  • Redness or pain, especially at place of injection

Check with your doctor as soon as possible if any of the following side effects occur while taking mitomycin:

Less common

  • Cough
  • decreased urination
  • shortness of breath
  • sores in mouth and on lips
  • swelling of feet or lower legs

Rare

  • Bloody vomit

Side effects not requiring immediate medical attention

Some side effects of mitomycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

  • Numbness or tingling in fingers and toes
  • purple-colored bands on nails
  • skin rash
  • unusual tiredness or weakness

Mitomycin sometimes causes a temporary loss of hair. After treatment has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, Check with your doctor immediately if you notice the following side effects:

  • Blood in urine

Also, check with your doctor if you notice any of the following:

  • Black, tarry stools
  • blood in stools
  • cough or hoarseness
  • decreased urination
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on skin
  • red or painful skin
  • shortness of breath
  • swelling of feet or lower legs
  • unusual bleeding or bruising

For Healthcare Professionals

Applies to mitomycin: compounding powder, intravenous powder for injection, intravesical solution, ureteral kit

Hematologic

Very common (10% or more): Bone marrow toxicity (64%), thrombocytopenia, leucopenia, pancytopenia, neutropenia, granulocytopenia, erythropenia, microangiopathic hemolytic anemia, myelodysplastic syndrome, thrombotic thrombocytopenic purpura[Ref]

Other

Very common (10% or more): Fever (14%)

Frequency not reported: Fatigue, edema, pain[Ref]

Dermatologic

Common (1% to 10%): Allergic skin rash, contact dermatitis, palmar-plantar erythema, pruritus, exanthema, integument and mucous membrane toxicity

Uncommon (0.1% to 1%): Alopecia[Ref]

Respiratory

Common (1% to 10%): Interstitial pneumonia, dyspnea, cough, shortness of breath

Rare (less than 0.1%): Pulmonary hypertension, pulmonary veno-occlusive disease (PVOD)[Ref]

Renal

Common (1% to 10%): Renal dysfunction, increase in serum creatinine, glomerulopathy, nephrotoxicity

Rare (less than 0.1%): Hemolytic uremic syndrome (HUS) (commonly fatal), microangiopathic-hemolytic anemia (MAHA syndrome)[Ref]

Cardiovascular

Rare (less than 0.1%): Heart failure (after previous therapy with anthracyclines)[Ref]

Gastrointestinal

Very common (10% or more): Anorexia (14%), nausea (14%), vomiting (14%)

Uncommon (0.1% to 1%): Mucositis, stomatitis, diarrhea[Ref]

Genitourinary

Common (1% to 10%): Cystitis (possibly hemorrhagic), dysuria, nocturia, pollakiuria, hematuria, local irritation of the bladder wall

Very rare (less than 0.01%): Necrotizing cystitis, allergic (eosinophilic) cystitis, stenosis of the efferent urinary tract, reduced bladder capacity, bladder wall calcification, bladder wall fibrosis, bladder perforation

Frequency not reported: Increased frequency of micturition, rash and pruritus on hands and genital area

Postmarketing reports: Bladder fibrosis/contraction rarely requiring cystectomy[Ref]

Hypersensitivity

Very rare (less than 0.01%): Severe allergic reaction[Ref]

Immunologic

Rare (0.01% to 0.1%): Life-threatening infection (e.g., bacterial, viral, fungal), sepsis, hemolytic anemia

Frequency not reported: Septic shock[Ref]

Local

Common (1% to 10%): Following extravasation: Cellulitis, tissue necrosis[Ref]

Ocular

Frequency not reported: Blurred vision[Ref]

Psychiatric

Frequency not reported: Confusion[Ref]

Hepatic

Rare (less than 0.1%): Liver dysfunction, increased transaminases, jaundice, veno-occlusive disease (VOD)[Ref]

Oncologic

Frequency not reported: Myelodysplastic syndrome, acute myeloid leukemia, acute leukemia[Ref]

Nervous system

Frequency not reported: Headache, drowsiness, syncope[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. MitoMYcin (mitoMYcin (mitomycin))." BluePoint Laboratories, Norwich, NY.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.