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Mutamycin

Last reviewed on RxList: 1/2/2018
Mutamycin Side Effects Center

Last reviewed on RxList 1/2/2018

Mutamycin (mitomycin) for Injection is an antibiotic that acts as an antineoplastic (anticancer) medication used to treat cancer of the stomach and pancreas. The brand name Mutamycin is discontinued, but generic versions may be available. Common side effects of Mutamycin (mitomycin) include nausea and vomiting (may be severe), stomach/abdominal pain, loss of appetite, headache, blurred vision, drowsiness, dizziness, or weakness. Temporary hair loss may occur. Normal hair growth should return after treatment with Mutamycin has ended.

Administer 20 mg/m2 Mutamycin intravenously as a single dose at 6 to 8 week intervals. Mutamycin may interact with "live" vaccines. Tell your doctor all medications and supplements you use. Mutamycin is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Both males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor to discuss birth control. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Mutamycin (mitomycin) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Mutamycin Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mitomycin can damage red blood cells, which may cause irreversible kidney failure. Call your doctor right away if you have:

  • pale skin, unusual bruising or bleeding;
  • confusion, tiredness or irritability;
  • stomach pain, bloody diarrhea, red or pink urine;
  • swelling, rapid weight gain; or
  • little or no urinating.

Call your doctor at once if you have:

  • signs of infection (fever, weakness, cold or flu symptoms, skin sores, frequent or recurring illness);
  • wheezing, chest tightness, new or worsening cough, trouble breathing;
  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing; or
  • pain, burning, redness, irritation, or skin changes where the injection was given.

Common side effects may include:

  • fever or other signs of infection;
  • nausea, vomiting, diarrhea, loss of appetite;
  • mouth sores;
  • drowsiness, headache;
  • blurred vision; or
  • temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mutamycin (Mitomycin)

Mutamycin Professional Information

SIDE EFFECTS

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. MUTAMYCIN (mitomycin) produces cumulative myelosuppression.

Integument and Mucous Membrane Toxicity: This has occurred in approximately 4% of patients treated with MUTAMYCIN (mitomycin for injection, USP). 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 MUTAMYCIN (mitomycin) , even when no obvious evidence of extravasation was observed during administration. Skin grafting has been required in some of the cases.

Renal Toxicity: 2% of 1,281 patients demonstrated a statistically significant rise in creatinine. There appeared to be no correlation between total dose administered or duration of therapy and the degree of renal impairment.

Pulmonary Toxicity: This has occurred infrequently but can be severe and may be life threatening. Dyspnea with a nonproductive cough and radiographic evidence of pulmonary infiltrates may be indicative of MUTAMYCIN (mitomycin) -induced pulmonary toxicity. If other etiologies are eliminated, MUTAMYCIN (mitomycin) therapy should be discontinued. Steroids have been employed as treatment of this toxicity, but the therapeutic value has not been determined. A few cases of adult respiratory distress syndrome have been reported in patients receiving MUTAMYCIN (mitomycin) in combination with other chemotherapy and maintained at FIO2 concentrations greater than 50% perioperatively.

Hemolytic Uremic Syndrome (HUS): This serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia (hematocrit ≤ 25%), thrombocytopenia ( ≤ 100,000/mm3), and irreversible renal failure (serum creatinine ≥ 1.6 mg/dL) has been reported in patients receiving systemic MUTAMYCIN (mitomycin) . Microangiopathic hemolysis with fragmented red blood cells on peripheral blood smears has occurred in 98% of patients with the syndrome. Other less frequent complications of the syndrome may include pulmonary edema (65%), neurologic abnormalities (16%), and hypertension. Exacerbation of the symptoms associated with HUS has been reported in some patients receiving blood product transfusions. A high mortality rate (52%) has been associated with this syndrome.

The syndrome may occur at any time during systemic therapy with MUTAMYCIN (mitomycin) as a single agent or in combination with other cytotoxic drugs. Less frequently, HUS has also been reported in patients receiving combinations of cytotoxic drugs not including MUTAMYCIN (mitomycin) . Of 83 patients studied, 72 developed the syndrome at total doses exceeding 60 mg of MUTAMYCIN (mitomycin) . Consequently, patients receiving ≥ 60 mg of MUTAMYCIN (mitomycin) should be monitored closely for unexplained anemia with fragmented cells on peripheral blood smear, thrombocytopenia, and decreased renal function.

The incidence of the syndrome has not been defined.

Therapy for the syndrome is investigational.

Cardiac Toxicity: Congestive heart failure, often treated effectively with diuretics and cardiac glycosides, has rarely been reported. Almost all patients who experienced this side effect had received prior doxorubicin therapy.

Acute Side Effects Due to MUTAMYCIN (mitomycin) were fever, anorexia, nausea, and vomiting. They occurred in about 14% of 1,281 patients.

Other: Headache, blurring of vision, confusion, drowsiness, syncope, fatigue, edema, thrombophlebitis, hematemesis, diarrhea, and pain. These did not appear to be dose related and were not unequivocally drug related. They may have been due to the primary or metastatic disease processes. Malaise and asthenia have been reported as part of postmarketing surveillance. Bladder fibrosis/contraction has been reported with intravesical administration (see PRECAUTIONS).

Read the entire FDA prescribing information for Mutamycin (Mitomycin)

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© Mutamycin Patient Information is supplied by Cerner Multum, Inc. and Mutamycin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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