Gemcitabine Intravesical System (Inlexzo™)

How Gemcitabine Intravesical System (Inlexzo™) is Given

Gemcitabine intravesical system is inserted (placed) directly into your bladder (called intravesicular) through a catheter (a flexible tube). The catheter is placed by your provider in the office. Do not empty your bladder (urinate) right before your appointment to have the catheter placed. Having urine in your bladder helps release the medication into your bladder. The gemcitabine intravesical system will be left in your bladder for 3 weeks. After it is inserted, you can empty your bladder (urinate). 

Your provider will tell you how often this intravesical system will be placed, but often it is placed once every 3 weeks for 6 months (8 doses), followed by once every 12 weeks for up to 18 months (6 doses).

There are some precautions you will need to take after the gemcitabine intravesical system is placed:

• Avoid contact between your skin and urine while the gemcitabine intravesical system is in your bladder and for at least 24 hours after it is removed:
  • Both males and females should sit on the toilet to urinate.
  • Flush the toilet while standing after each use.
  • Wash your hands with soap and water after urinating.
  • Wash your genital area with water after urinating.
• Wash clothing soiled with urine right away and separately from other clothing.
• Drink about 6 to 7 cups (1500 milliliters/1.5 liters) of fluids per day during treatment with gemcitabine intravesical system to make sure you make enough urine for the medicine to be released into the bladder.

Possible Side Effects of Gemcitabine Intravesical System (Inlexzo)

There are a number of things you can do to manage the side effects of gemcitabine intravesical system. Talk to your provider about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Urinary Changes

• Urinary frequency: You may feel the need to urinate more frequently than normal.
• Urinary tract infections (UTI): You may have a bacterial infection in any part of your urinary system, such as your kidneys, ureters, bladder, or urethra. Symptoms may be frequent urinating, pain or burning, cloudy or foul-smelling urine, fever, and pain in the abdomen (belly), back, or side.
• Dysuria: You may have pain or burning while urinating.
• Urinary urgency: You may have a sudden (out of nowhere) and strong need to urinate.
• Urinary tract pain: You may have an ache or throbbing in your lower abdomen or lower back.
• Blood in urine (hematuria): Check for blood in the toilet or on the toilet paper when you urinate.
• Bladder irritation: You may have pain or tenderness in your lower abdomen or lower back. This irritation often gets worse when your bladder is full and gets better when you urinate.

Tell your provider if you have any of these symptoms or changes to your urinary habits.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your provider know if you experience any shortness of breath, difficulty breathing, or pain in your chest. If the hemoglobin count gets too low, you may need to receive a blood transfusion.

Low White Blood Cell Count (Lymphocytopenia)

Lymphocytes are a type of white blood cell. White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. Tell your provider right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.
Tips to prevent infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (those who have a cold, fever, or cough or if you live with someone with these symptoms).
• When working in your yard, wear protective clothing, including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care. Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your provider before scheduling dental appointments or procedures.
• Ask your provider before you, or someone you live with, has any vaccinations.

Increased Lipase Level

This medication can cause an increase in the enzyme lipase which helps your body to digest fats. Your lipase levels will be monitored using blood tests. Tell your provider if you have abdominal (belly) pain, fever, or nausea and/or vomiting. 

Kidney Function Changes

This medication can cause kidney problems, including an increased creatinine level, which your provider may monitor for using blood tests. Notify your provider if you notice decreased urine output, blood in the urine, swelling in the ankles, or loss of appetite.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (such as potassium) in your body. Your levels will be monitored using blood tests. If your levels become too low, your provider may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your provider. Signs of low potassium may be fatigue, muscle weakness, dizziness, and headache. 

Sexual & Reproductive Concerns

This medication may affect a man’s ability to have children. You may want to consider sperm banking if you may wish to have a child in the future. Talk about these options with your provider.

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Tell your provider right away if you become pregnant or think you may be pregnant during treatment. Effective birth control for females is necessary during treatment and for at least 6 months after the final removal of the  gemcitabine intravesical system. For males, effective birth control should be used during treatment and for 3 months after the final removal of the gemcitabine intravesical system. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed during treatment and for 1 week after final removal of the gemcitabine intravesical system.