Valrubicin Intravesical

WHY is this medicine prescribed?

Valrubicin solution is used to treat a type of bladder cancer (carcinoma in situ; CIS) that was not effectively treated with another medication (Bacillus Calmette-Guerin; BCG therapy) in patients that can not have surgery right away to remove all or part of the bladder. However, only about 1 out of 5 patients responds to treatment with valrubicin and delaying bladder surgery may lead to the spread of bladder cancer which may be life-threatening. Valrubicin is an anthracycline antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Valrubicin comes as a solution (liquid) to be infused (injected slowly) through a catheter (small flexible plastic tube) into your bladder while you are lying down. Valrubicin solution is given by a doctor or a health care provider in a medical office, hospital, or clinic. It is usually given once a week for 6 weeks. You should keep the medication in your bladder for 2 hours or as long as possible. At the end of 2 hours you will empty your bladder.

You may have symptoms of an irritable bladder during or shortly after treatment with valrubicin solution such as a sudden need to urinate or leaking of urine, If any valrubicin solution leaks out of the bladder and gets on your skin, the area should be cleaned with soap and water. Spills on the floor should be cleaned with undiluted bleach.

Drink plenty of fluids after receiving your treatment with valrubicin.

Your doctor will watch you carefully to see how well treatment with valrubicin works for you. If you do not respond fully to treatment after 3 months or if your cancer returns, your doctor will probably recommend treatment with surgery.

What SPECIAL PRECAUTIONS should I follow?

Before receiving valrubicin solution,

• tell your doctor and pharmacist if you are allergic to valrubicin, daunorubicin, doxorubicin, epirubicin, or idarubicin; any other medications; or any of the ingredients in valrubicin solution. Ask your doctor for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have a urinary tract infection, or if you urinate frequently because you have small bladder. Your doctor will not want you to receive valrubicin solution.

• your doctor will look at your bladder before giving valrubicin solution 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 are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are using valrubicin. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with valrubicin. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while using valrubicin, call your doctor.

• do not breastfeed while you are using valrubicin.

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 a dose of valrubicin, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Valrubicin may cause side effects. Your urine may turn a red; this effect is common and not harmful if it happens in the first 24 hours after treatment. Tell your doctor if any of these symptoms are severe or do not go away:

• frequent, urgent, or painful urination
• difficulty urinating
• abdominal pain
• nausea
• headache
• weakness
• tiredness

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

• red colored urine occurring more than 24 hours after treatment
• painful urination occurring more than 24 hours after treatment
• blood in urine

Valrubicin 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 know about STORAGE and DISPOSAL of this medication?

This medication will be stored at your doctor's office or clinic.

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 https://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.

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.