Valrubicin is used to treat bladder cancer. The usual treatment for bladder cancer is surgery. However, if you and your doctor decide that the risk of surgery is greater than its benefit or that surgery may be delayed, this medication may be used as part of your treatment.

This medication belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells.

This medication may not cure your cancer. Delaying surgery could lead to a more serious illness (metastatic cancer). Discuss the risks and benefits of this medication with your doctor.

This medication is given by placement into the bladder as directed by your doctor, usually once weekly for 6 weeks. Do not give by injection into a vein or muscle or under the skin. After this medication is placed through a tube (catheter), it is usually left in the bladder for 2 hours, then released by urinating.

Drink plenty of fluids after each treatment with this medication unless otherwise directed by your doctor. Doing so helps clear it from your body and decrease side effects.

Bladder irritation, with symptoms such as pain, spasm, and frequent urge to urinate, usually occurs. This medication usually will cause your urine to turn a reddish color. This is a normal, harmless effect of the drug and should not be mistaken for blood in your urine. If any of these effects last or get worse after 24 hours, tell your doctor right away.

Infrequent side effects include nausea, abdominal/stomach pain, diarrhea, headache, weakness, dizziness, or back pain. If any of these effects last or get worse, tell your doctor.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• bloody urine
• signs of infection (such as fever, chills)
• unusual tiredness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• trouble breathing
• severe dizziness

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using valrubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (such as doxorubicin); or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• small bladder size or other bladder problems (such as perforation, incontinence)
• current urinary infection/symptoms of bladder irritation (including pain, spasm, frequent urge to urinate)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using valrubicin. Valrubicin may harm an unborn baby. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as biopsy, cystoscopy, urine cytology) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor right away for a new dosing schedule. Do not double the dose to catch up.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.