Mitomycin pyelocalyceal is used to treat a certain type of urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) in adults. Mitomycin is in a class of medications called anthracenediones (anticancer antibiotics). Mitomycin pyelocalyceal treats cancer by stopping the growth and spread of certain cells.

Mitomycin comes as a powder to be mixed with a gel solution and given through a catheter (a small flexible plastic tube) into the kidney. It is given by a doctor or other health care provider in a medical office, hospital, or clinic. It is usually given once a week for 6 weeks. If you are responding to mitomycin pyelocalyceal 3 months after beginning treatment, it may continue to be given once a month for up to 11 months.

Before receiving each mitomycin dose, your doctor may tell you to take sodium bicarbonate. Talk to your doctor about how to take sodium bicarbonate before receiving mitomycin.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before receiving mitomycin pyelocalyceal,

• tell your doctor and pharmacist if you are allergic to mitomycin, any other medications, or any of the ingredients in the mitomycin preparation. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: diuretics ('water pills').
• tell your doctor if you have a hole or tear in your bladder or urinary tract. Your doctor will probably tell you not to receive mitomycin pyelocalyceal.
• tell your doctor if you have or have ever had high blood pressure or kidney disease.
• tell your doctor if you or your partner are pregnant, plan to become pregnant, or if you plan on fathering a child. You should not become pregnant during your treatment with mitomycin pyelocalyceal. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for 6 months after your final dose. If you are male, you and your female partner should use birth control during your treatment and for 3 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner becomes pregnant during your treatment with mitomycin pyelocalyceal, call your doctor immediately. Mitomycin pyelocalyceal may harm the fetus.
• tell your doctor if you are breastfeeding. Do not breastfeed while you are receiving mitomycin pyelocalyceal and for 1 week after your final dose.
• you should know that mitomycin pyelocalyceal may temporarily change the color of your urine to a violet-blue color after you receive a dose. You must avoid contact with your urine for at least 6 hours after each dose. Both males and females must urinate by sitting on a toilet and flush the toilet several times after use. Then, you must wash your hands, inner thighs, and genital area well with soap and water. If any clothing comes into contact with the urine, it should be washed right away and separately from other clothing.
• you should know that mitomycin pyelocalyceal may cause swelling and narrowing of the ureter (tubes that carry urine from the kidney to the bladder). If you experience any of the following symptoms, call your doctor immediately: back or side pain, or fever. Your doctor may recommend placement of a ureteral stent (plastic tube surgically placed in the ureter) to allow urine to flow from the kidney to the bladder.

If you miss an appointment to receive a dose of mitomycin pyelocalyceal, call your doctor as soon as possible to reschedule.

Unless your doctor tells you otherwise, continue your normal diet.

Mitomycin pyelocalyceal may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• stomach pain
• decreased appetite
• fatigue
• itching

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• fever, chills, or other signs of infection
• unexplained bleeding or bruising; black and tarry stools; red blood in stools; bloody vomit; vomited material that looks like coffee grounds; or blood in urine
• unusual tiredness or weakness, pale skin, shortness of breath, or dizziness or lightheadedness
• painful or difficult urination
• increased urinary frequency or urgency

Mitomycin pyelocalyceal may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to mitomycin pyelocalyceal.

Ask your pharmacist any questions you have about mitomycin pyelocalyceal.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Jelmyto®