Mitomycin (Intravenous)

Mitomycin is part of a group of medicines called antineoplastics. It is used to treat certain types of cancer.

Mitomycin works by interfering with the growth of cancer cells, which are eventually destroyed. It may also affect the growth of normal body cells, leading to other effects. Some of these effects can be serious and should be reported to your doctor. Other effects, such as hair loss, may not be serious but can be concerning. Some effects might not appear for months or years after using the medicine.

Before starting treatment with mitomycin, you and your doctor should discuss the benefits of this medicine as well as the risks associated with it.

Mitomycin should be given only by or under the direct supervision of your doctor.

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

While you are being treated with mitomycin, and after you finish treatment with it, do not get any immunizations (vaccinations) without your doctor's approval. Mitomycin may lower your body's resistance, which means you could get the infection that the immunization is meant to prevent. Additionally, others in your household should not take oral polio vaccine, as they might pass the polio virus to you. Also, stay away from people who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for long. If you cannot take these precautions, you should think about wearing a protective face mask that covers your nose and mouth.

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

• If possible, avoid people with infections. Contact your doctor immediately if you think you might be getting an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in your 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 suggest other ways to clean your teeth and gums. Consult 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 using sharp objects like a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could happen.

If mitomycin accidentally leaks out of the vein where it is injected, it may damage the skin and cause scarring. In some patients, this might happen weeks or even months after the medicine is given. Inform the doctor or nurse immediately if you notice redness, pain, or swelling at the injection site or anywhere else on your skin.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. Here are some important points to think about for this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There is no specific information comparing the use of mitomycin in children to its use in other age groups. It is not expected to cause different side effects or problems in children than in adults.

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together despite potential interactions. In these cases, your doctor may adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are highlighted due to their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you are taking.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Hexaminolevulinate
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Tamoxifen
• Typhoid Vaccine, Live
• Vinblastine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions could occur. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may impact the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Bleeding problems

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

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

• Kidney disease—May be worsened

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

Also, because of how cancer medicines act on the body, there is a chance they might cause other unwanted effects that may not happen until months or years after using the medicine. 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:

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 the injection site

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

Some side effects may happen 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

• 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 using this medicine, it may still produce some side effects that need attention. During this time, check with your doctor immediately if you notice the following side effect:

• 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Mutamycin

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.