Mitomycin (gel)

Mitomycin (gel) is used in adults to treat cancer of the lining of the upper urinary tract, which includes the kidney.

Mitomycin (gel) may also be used for reasons not mentioned in this medication guide.

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

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

Mitomycin gel is usually given once a 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 violet or blue in color.

After you are treated with this medicine, your urine will contain harmful materials. For at least 6 hours after each treatment with mitomycin gel:

• Use a toilet instead of 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 thoroughly 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 immediately and separately from other laundry.

Mitomycin (gel) may cause swelling and narrowing of your ureter (the tube that carries urine from your kidney to your bladder). Call your doctor immediately if you have a fever and pain in your side or lower back.

You should not be treated with mitomycin if you are allergic to mitomycin (gel), or if you have:

• 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.

Mitomycin (gel) can harm an unborn baby if the mother or the father is using this medicine.

• 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).

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

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

Mitomycin (gel) may cause swelling and narrowing of your ureter (the tube that carries urine from your kidney to your bladder). Call your doctor right away if you have a fever and pain in your side or lower back.

Also call your doctor immediately if you have:

• pain or difficulty urinating;
• 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 of mitomycin (gel) 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.

Usual Adult Dose for Stomach Cancer:

After full hematologic recovery from any previous chemotherapy: 20 mg/m2 IV at 6- to 8-week intervalsComments:-Because of cumulative myelosuppression, patients should be reevaluated after each course of this drug and the dose reduced if the patient has experienced toxicity. -Doses greater than 20 mg/m2 have not been shown to be more effective and are more toxic than lower doses.Uses: -For disseminated adenocarcinoma of the stomach in proven combination with other approved chemotherapeutic agents or as palliative treatment when other modalities have failed-For disseminated adenocarcinoma of the pancreas in proven combination with other approved chemotherapeutic agents or as palliative treatment when other modalities have failed

Usual Adult Dose for Gastric Cancer:

After full hematologic recovery from any previous chemotherapy: 20 mg/m2 IV at 6- to 8-week intervalsComments:-Because of cumulative myelosuppression, patients should be reevaluated after each course of this drug and the dose reduced if the patient has experienced toxicity. -Doses greater than 20 mg/m2 have not been shown to be more effective and are more toxic than lower doses.Uses: -For disseminated adenocarcinoma of the stomach in proven combination with other approved chemotherapeutic agents or as palliative treatment when other modalities have failed-For disseminated adenocarcinoma of the pancreas in proven combination with other approved chemotherapeutic agents or as palliative treatment when other modalities have failed

Call your doctor to set up a new appointment if you miss an appointment for your mitomycin (gel) treatment.

Since mitomycin is given by a healthcare professional in a medical setting, an overdose is unlikely to happen.

For at least 6 hours after each treatment, do not let your urine come into contact with your skin.

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.