mitomycin (gel)

What is the most important information I should know about mitomycin gel?

What is mitomycin gel?

Mitomycin gel is used in adults to treat cancer of the lining of the upper urinary tract including the kidney.

Mitomycin gel may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving mitomycin gel?

• a perforation (a hole or tear) in your bladder or upper urinary tract.

You may need to have a negative pregnancy test before starting this treatment.

• If you are a woman, do not use mitomycin gel if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using mitomycin gel.

How is mitomycin gel given?

Mitomycin gel is injected directly into the kidney using a catheter inserted into the urethra (the tube for passing urine out of your bladder). A healthcare provider will give you this medicine.

Before each treatment with mitomycin gel, you will need to take another medicine called sodium bicarbonate. Carefully follow your doctor's instructions about taking this medicine.

Mitomycin gel is usually given once per week for 6 weeks.

It is very important to receive all treatments as prescribed by your doctor.

In some cases, mitomycin gel may be given for an additional 11 months after the first 6 treatments.

While receiving this medicine, your urine may appear to be violet or blue in color.

• Use a toilet rather than a urinal and sit on the toilet while urinating. Flush the toilet several times after use.
• Always wash your hands after using the bathroom. Also wash your inner thighs and genital area well with soap and water.
• Avoid handling any clean-up of your urine without wearing latex gloves.
• If any urine gets on your clothing, wash the clothing right away separately from other laundry.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving mitomycin gel?

For at least 6 hours after each treatment, avoid letting your urine come into contact with your skin.

What are the possible side effects of mitomycin gel?

• pain or difficult urination;
• blood in your urine; or
• low blood cell counts --fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

• side pain, urination problems, blood in your urine;
• kidney problems;
• tiredness; or
• nausea, vomiting, stomach pain.

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 other drugs will affect mitomycin gel?

Tell your doctor about all your other medicines, especially a diuretic or "water pill."

Other drugs may affect mitomycin gel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about mitomycin gel.