In the U.S.—

• Antineoplastic

Valrubicin (val-ROO-bi-sin ) is used as a solution that is run through a tube (instilled through a catheter) into the bladder to treat bladder cancer.

Valrubicin is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form(s):

Mucosal-Local
• Bladder instillation (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For valrubicin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to valrubicin or to similar medicines (daunorubicin, doxorubicin, epirubicin). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Valrubicin has not been studied in humans but has been found to cause birth defects and other problems in animals. Make sure your doctor knows if you are pregnant or if you intend to have children (for women and men).

Breast-feeding—It is not known whether valrubicin instilled into the bladder passes into breast milk. However, because of the possible harmful effects if it gets into the milk, breast-feeding is not recommended during treatment with this medicine.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of valrubicin in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of valrubicin in the elderly with use in other age groups, this medicine has been used mostly in patients older than 60 years of age and is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your doctor or pharmacist if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Bladder irritation or other bladder problems—Increased risk of unwanted effects

• Small bladder—Possible trouble in being able to hold all of the solution
• Urinary tract infection

Your doctor may ask you to empty your bladder completely before the solution is instilled into it (unless a tube is used to drain the bladder).

Follow your doctor's instructions carefully about how long to hold the solution in your bladder:

• The solution should be held in your bladder for 2 hours. If you think you cannot hold it, tell your health care professional.

It is important that you drink extra fluids after each treatment with valrubicin so that you will pass more urine.

Dosing—

The dose of valrubicin may be different for different patients. If you have any questions about the proper dose of valrubicin, ask your doctor.

• For bladder instillation dosage form (solution):
  • For bladder cancer:
    • Adults—800 milligrams (mg) (75 milliliters [mL]) instilled into the bladder once a week for six weeks.

Valrubicin commonly causes the urine to turn red for about 24 hours after it is given. This is normal and is no cause for concern. However, tell your doctor if you continue to pass red urine for longer than 24 hours.

Along with its needed effects, a medicine may cause some unwanted effects. The following side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Blood in urine;  loss of bladder control ;  painful or difficult urination;  red color in urine;  strong urge to urinate;  unusually frequent urination 
  
  

• Less common
  • Increased urination at night;  local burning sensation 
  
  

• Rare
  • Frequent urge to defecate;  itching;  loss of sense of taste 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.