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

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

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

Jelmyto 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 Jelmyto, you will need to take another medicine called sodium bicarbonate. Carefully follow your doctor's instructions about taking this medicine.

Jelmyto 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, Jelmyto 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.

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

• 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.

You should not be treated with Jelmyto if you are allergic to Jelmyto, 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.

Jelmyto can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Jelmyto 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 Jelmyto.

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

Call your doctor to reschedule if you miss an appointment for your Jelmyto gel treatment.

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

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

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

Jelmyto may cause swelling and narrowing of your ureter (the tube that urine travels through 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 at once if you have:

• 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 of Jelmyto 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.

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

Other drugs may affect Jelmyto, 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.