Valstar is used to treat bladder cancer that has not spread to other parts of the body.

Most people do not have a complete response to Valstar. You may eventually need surgery to remove your bladder to keep the cancer from becoming metastatic (spreading to other parts of your body).

Valstar may also be used for purposes not listed in this medicine guide.

You may not have a complete response to Valstar, and your bladder may need to be surgically removed to prevent your cancer from spreading to other parts of your body.

Valstar is injected directly into the bladder using a catheter inserted into the urethra (the tube for passing urine out of your bladder). A healthcare provider will give you this medicine, usually once per week for 6 weeks.

Valstar is usually given in a solution that amounts to about 2.5 ounces (1/3 cup). This entire amount is injected into the bladder and should be held in for 2 hours. Avoid using the bathroom during this time.

Tell your doctor if you have trouble holding in the medicine for the full 2 hours.

If this medicine accidentally gets on your skin, wash it thoroughly with soap and warm water.

Your will need frequent urine tests, and you may also need a bladder biopsy or a bladder exam using a scope.

Drink plenty of water after each time you receive Valstar.

You may not have a complete response to Valstar. After 3 months of treatment without response, your bladder may need to be surgically removed. This can help prevent your cancer from spreading to other parts of your body. Metastatic bladder cancer is usually fatal.

You should not be treated with Valstar if you are allergic to it, or if you have:

• a urinary tract infection;

• bladder perforation (a hole or tear); or

• an allergy to polyoxyl castor oil, or to other cancer medicines (daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone).

Tell your doctor if you have ever had:

• overactive bladder, incontinence or leakage;

• bladder surgery; or

• trouble holding a large amount of urine in your bladder.

It may be harder for you to get a woman pregnant while you are using Valstar. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

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

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

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Call your doctor for instructions if you miss an appointment for your Valstar.

Since Valstar is given by a healthcare professional in a medical setting, an overdose is unlikely but may cause worsening bladder symptoms.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Valstar may cause serious side effects. Call your doctor at once if you have:

• blood in your urine or painful urination lasting for longer than 24 hours;

• pain or burning when you urinate; or

• low white blood cell counts (about 1 week after a Valstar injection)--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Common side effects of Valstar may include:

• red or pink urine within the first 24 hours after you receive Valstar;

• increased urge to urinate, urine leakage;

• painful or difficult urination;

• bladder pain;

• increased urination at night; or

• nausea, 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.

Because Valstar is not absorbed into the bloodstream, it is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.