Valstar

Valstar is used as a solution that is run through a tube (instilled through a catheter) into the bladder to treat bladder cancer.

Valstar is to be administered only by or under the immediate supervision of your doctor. This product is available in the following dosage forms: Solution.

Before using Valstar, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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

Geriatric Population: 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.

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: 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.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Trastuzumab

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Bladder irritation or other bladder problems—Increased risk of unwanted effects
• Small bladder—Possible trouble in being able to hold all of the solutions
• Urinary tract infection

To use Valstar properly, you must follow all instructions given by your doctor. 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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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.

In using Valstar, you must be careful and take some precautions as advised by your doctor. Valstar 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.

As with many medications, there are several potential side effects associated with Valstar. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them.

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.