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About low-grade UTUC About JELMYTO Results with JELMYTO Your treatment plan Patient resources

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Low-grade UTUC: What you need to know

UTUC stands for “upper tract urothelial cancer.” It is a rare cancer that develops in the area where urine moves out of your kidney—the good news is that it's treatable.

A
Kidney
- Removes wastes and extra fluid
- Controls blood pressure
- Makes red blood cells
- Keeps bones healthy
B
Ureter
- Moves urine from the kidney to the bladder
C
Bladder
- Stores urine
D
Urethra
- Moves urine from the bladder to the outside of your body

UTUC Diagram Image

UTUC Diagram Image

Why people get UTUC

Several factors may increase your risk for UTUC, but it isn’t always possible to determine a cause.

Smoking
Smoking is the most common risk factor for developing cancer, including low-grade UTUC. If you need help quitting smoking, talk to your doctor.
Age
Getting older increases your chances of getting UTUC. Most cases of UTUC occur in people who are between 68 and 73 years of age.
Exposure to chemicals
People who work in certain jobs may have a higher risk of getting cancers like low-grade UTUC because of exposure to chemicals and hazardous substances.
Medical history
Your chances of getting low-grade UTUC may increase if you and other family members had other types of cancer (colorectal or bladder cancer).

What is low-grade UTUC?

In UTUC, “low-grade” means your cancer is less aggressive and is slow to spread. Even so, it’s still important to treat it.

Treatment helps to control your symptoms and prevent serious kidney damage. Because your UTUC is low grade, your treatment options include JELMYTO, an alternative treatment to removing your kidney.

Until now, kidney removal has been one of the standard methods of treating low-grade UTUC, but kidney removal may have a major impact on overall health, including blood pressure and heart disease.

Why it’s important to treat your low-grade UTUC

Like all cancers, low-grade UTUC is a serious disease. If not treated, UTUC can cause significant health problems like irreversible kidney damage.

Approved Use for JELMYTO

JELMYTO™ is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

Important Safety Information

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.
Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).

How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.

The most common side effects of JELMYTO include: side pain, urinary tract infection, blood in your urine, kidney problems, tiredness, nausea, stomach pain, trouble with urination, vomiting, low red blood cell count, frequent urination, itching, chills, and fever.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please click here for JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

Please click here for Full Prescribing Information, Instructions for Pharmacy and Instructions for Administration.