VALRUBICIN (Mucosal-Local)

Some commonly used brand names are:

In the U.S.?

• Valstar

Category

• Antineoplastic

Description

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

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

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

Before Using This Medicine

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 followingshould be considered:

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

Pregnancy?Valrubicin has not been studied in humans but hasbeen found to cause birth defects and other problems in animals. Make sureyour doctor knows if you are pregnant or if you intend to have children (forwomen and men).

Breast-feeding?It is not known whether valrubicin instilled intothe bladder passes into breast milk. However, because of the possible harmfuleffects if it gets into the milk, breast-feeding is not recommended duringtreatment with this medicine.

Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of valrubicinin children with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing 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 ageand is not expected to cause different side effects or problems in older peoplethan it does in younger adults.

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

Other medical problems?The presence of other medicalproblems may affect the use of valrubicin. Make sure you tell your doctorif you have any other medical problems, especially:

• Bladder irritation or other bladder problems?Increased riskof unwanted effects

• Small bladder?Possible trouble in being able to hold all ofthe solution
• Urinary tract infection

Proper Use of This Medicine

Your doctormay ask you to empty your bladder completely before the solution is instilledinto it (unless a tube is used to drain the bladder).

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

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

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

Dosing?The dose of valrubicin may be different fordifferent 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]) instilledinto the bladder once a week for six weeks.

Precautions While Using This Medicine

Valrubicincommonly 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 youcontinue to pass red urine for longer than 24 hours.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause some unwanted effects. The following side effects may go away duringtreatment as your body adjusts to the medicine. However, check with your doctorif 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; localburning sensation

Rare

Otherside effects not listed above may also occur in some patients. If you noticeany other effects, check with your doctor.