In the U.S.—

In Canada—

• Antineoplastic

Mitomycin ( mye-toe-MYE-sin) belongs to the group of medicines known as antineoplastics. It is used to treat some kinds of cancer.

Mitomycin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by mitomycin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with mitomycin, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Mitomycin is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mitomycin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to mitomycin.

Pregnancy—Tell your doctor if you are pregnant or if you intend to have children. There is a chance that this medicine may cause birth defects if either the male or female is taking it at the time of conception or if it is taken during pregnancy. Studies have shown that mitomycin causes birth defects in animals. In addition, many cancer medicines may cause sterility which could be permanent. Although sterility has not been reported with this medicine, the possibility should be kept in mind.

Be sure that you have discussed this with your doctor before taking this medicine. It is best to use some kind of birth control while you are receiving mitomycin. Tell your doctor right away if you think you have become pregnant while receiving mitomycin.

Breast-feeding—Tell your doctor if you are breast-feeding or if you intend to breast-feed during treatment with this medicine. Because mitomycin may cause serious side effects, breast-feeding is generally not recommended while you are receiving it.

Children—Although there is no specific information comparing use of mitomycin in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mitomycin in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving mitomycin, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with radiation or cancer medicines—Mitomycin may increase the effects of these medicines or radiation therapy on the blood

• Bleeding problems

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Infection—Mitomycin may decrease your body's ability to fight infection

• Kidney disease—May be worsened

Mitomycin is usually given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to remember to take them at the right times.

This medicine often causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing—

The dose of mitomycin will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's size, and whether or not other medicines are also being taken. If you are receiving mitomycin at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of mitomycin, ask your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with mitomycin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Mitomycin may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Mitomycin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

If mitomycin accidentally seeps out of the vein into which it is injected, it may damage the skin and cause scarring. In some patients, this may occur weeks or even months after this medicine is given. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection or anywhere else on your skin.

Along with its needed effects, a medicine 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 or nurse immediately if any of the following side effects occur:

• 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:

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

• Rare
  • Bloody vomit 
  
  

Other side effects 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 doctor if any of the following side effects continue or are bothersome or if you have any questions about them:

• More common
  • Loss of appetite;  nausea and vomiting  
  
  

• 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 receiving mitomycin, 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:

• 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 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.