When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to valrubicin, Cremophor® EL (which this medicine contains), or other cancer medicines, such as daunorubicin (Cerubidine®, Daunoxome®), doxorubicin (Adriamycin®, Rubex®, Doxil®), epirubicin (Ellence™), or idarubicin (Idamycin®). You should not use this medicine if you have a bladder infection or bladder perforation.

How to Use This Medicine:
Liquid

• This medicine, like all medicines used to treat cancer, is very strong. Make sure you understand why you are getting it and what the risks and benefits of treatment are. It is important for you to work closely with your doctor.
• You will receive this medicine while you are in a hospital or cancer treatment center. This treatment is usually given once a week for six weeks, or as your doctor orders.
• This medicine is given through a tube (catheter) inserted into your bladder through the urethra, which is the opening where urine is emptied from your body.
• Before treatment, you should empty your bladder.
• After the tube is inserted, all urine in your bladder will be drained. The medicine is then allowed run into your bladder through the tube over a period of a few minutes.
• The tube is then taken out, and you will hold the medicine in your bladder for up to 2 hours.
• At the end of the treatment time, you will urinate to remove the medicine from your bladder.
• If you cannot keep the medicine in your bladder for the two full hours, tell your doctor, nurse, or other caregiver.
• Drink plenty of fluids after each treatment.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you have been treated with other cancer medicines or radiation.

Warnings While Using This Medicine:

• You should not get pregnant while you or your sexual partner are receiving this medicine. Use an effective form of birth control while you are being treated with this medicine. This is important whether you are a man or a woman.
• If you are pregnant, talk to your doctor before having treatments with valrubicin.
• If you are breastfeeding, discontinue breastfeeding before starting treatment with this medicine.
• Make sure your doctor knows if you have severe bladder spasms, or loss of bladder control.
• This medicine is a clear red liquid. You may notice red-colored urine for up to 24 hours following a treatment. If this lasts longer than 24 hours, call your doctor immediately.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Bladder spasms lasting longer than 24 hours after a treatment
• Fatigue, shortness of breath, uneven heartbeat
• Rapid weight gain or swelling of hands, ankles, or feet
• Red-colored urine lasting longer than 24 hours after a treatment

If you notice these less serious side effects, talk with your doctor:

• Bloody urine
• Incontinence (unable to control bladder)
• Nausea
• Pain or burning with urination
• Stomach or low back pain
• Urinating more often, or feeling like you have to urinate more often
• Urinating often at night

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088