"Nov. 29, 2012 (Chicago) -- For cancer patients undergoing chemotherapy who have found their complaints of general mental fogginess and haziness dismissed by their doctors as not being a real medical condition, vindication has arrived.
Mutamycin Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Mutamycin in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects from mitomycin, contact your doctor immediately:
- an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- kidney damage (little or no urine production, blood in the urine, lower back or side pain, difficulty urinating, or swelling of the ankles or feet);
- decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
- redness, pain or swelling at the place of injection or elsewhere on the skin;
- severe nausea, vomiting, diarrhea, or loss of appetite; or
- shortness of breath or difficulty breathing.
Other, less serious side effects may be more likely to occur. Continue taking mitomycin and talk to your doctor if you experience:
- mild to moderate nausea, vomiting, or loss of appetite;
- blurred vision;
- drowsiness or dizziness;
- weakness; or
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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Mutamycin (Mitomycin) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Mutamycin Overview - Patient Information: Side Effects
Nausea, vomiting, stomach/abdominal pain, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.
Severe nausea and vomiting may infrequently result in a loss of too much body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin.
Temporary hair loss may occur. Normal hair growth should return after treatment has ended.
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor right away if you have any serious side effects, including: unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, vomit that looks like coffee grounds), numbness/tingling feelings, unusual tiredness/weakness.
Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.
If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Symptoms may occur both during treatment or weeks to months after receiving a dose. Tell your doctor immediately if you notice redness, pain, or swelling at or near the injection site.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing (especially with cough).
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Mutamycin (Mitomycin)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Mutamycin FDA Prescribing 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.
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) »
Additional Mutamycin Information
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