Class Name(s):

• 10:00 Antineoplastic Agents

Pronunciation:

• (jem sit' a been)

Brand Name(s):

• Inlexzo^®

WHY is this medicine prescribed?

Gemcitabine intravesical system is used to treat a certain type of bladder cancer. Gemcitabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells.

HOW should this medicine be used?

Gemcitabine intravesical system comes as a flexible tube to be inserted inside of the bladder by a health-care provider. Gemcitabine intravesical system is left in place in the bladder for 3 weeks. After 3 weeks, the system is removed from your bladder by a health-care provider. Gemcitabine intravesical system is inserted into the bladder every 3 weeks for up to 6 months (8 doses) and then every 12 weeks for up to 6 more doses thereafter. The length of treatment depends on how well your body responds to the medication and any side effects you have.

Do not empty your bladder before the procedure to insert gemcitabine intravesical system. After the system is inserted into your bladder, you can urinate normally. Do not hold your urine.

Drink 6 to 7 cups of fluids every day during your treatment to produce enough urine for the medicine to be released from the system into your bladder.

Avoid contact of your urine with skin while the system is in place in your bladder and for at least 24 hours after it is removed. Sit down on a toilet to urinate. Flush the toilet after each use. Wash your hands with soap and water and wash your genital area with water each time you urinate. Wash clothing soiled with urine separately from other clothing.

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

Are there OTHER USES for this medication?

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

What SPECIAL PRECAUTIONS should I follow?

Before receiving gemcitabine intravesical system,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• your doctor will look at your bladder before inserting gemcitabine intravesical system to see if you have a hole in your bladder or a weak bladder wall. If you have these problems, your treatment will need to wait until your bladder has healed.
• tell your doctor if you have or have ever had anemia, or liver or kidney problems.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. If you can become pregnant, you will need to take a pregnancy test before starting treatment and use effective birth control during your treatment and for at least 6 months after gemcitabine intravesical system is removed. If your partner can become pregnant, use effective birth control during your treatment and for 3 months after the system is removed. Talk to your doctor about using birth control to prevent pregnancy during your treatment with gemcitabine intravesical system. If you or your partner becomes pregnant while receiving gemcitabine, call your doctor. Gemcitabine may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are receiving gemcitabine intravesical system and for 1 week after the system is removed.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of receiving gemcitabine intravesical system.
• tell your doctor if you will be having a magnetic resonance imaging exam (MRI; a medical test that uses powerful magnets to take pictures of the inside of the body) during your treatment with gemcitabine intravesical system.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive gemcitabine intravesical system or have it removed, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

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

• frequent, urgent, burning, or painful urination; or pain in the lower back or lower stomach
• difficulty urinating
• leakage of urine
• fatigue
• diarrhea
• pain in the genital area

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• blood in the urine

Gemcitabine intravesical system may cause other side effects. Call your doctor if you have any unusual problems while taking 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).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to gemcitabine intravesical system.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving gemcitabine intravesical system.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2025.