Valstar

Valstar is a prescription medication used to treat bladder cancer. Valstar belongs to a group of drugs called anthracyclines. These work by stopping the growth of cancer cells in your body.

This medication is available in an injectable form to be given directly into a the bladder by a healthcare professional.

Common side effects of Valstar include an increase need to urinate, pain when urinating, and bladder spasms.

Valstar is a prescription medication used to bladder cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
 

• Endo Pharmaceuticals Solutions Inc.

Serious side effects have been reported with Valstar. See the “Drug Precautions” section.

Common side effects of Valstar include the following:

• increase need to urinate
• pain when urinating
• bladder spasms
• blood in the urine
• bladder pain
• urine leakage

This is not a complete list of Valstar side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

• Valstar has been shown to induce complete responses in only about 1 in 5 patients. Delaying cystectomy (removal of the bladder) could lead to development of metastatic bladder cancer, which is lethal. Discuss with your doctor the relative risk of cystectomy versus the risk of metastatic bladder cancer.
• Major toxicities from Valstar are related to irritable bladder symptoms that may occur during use of Valstar. For the first 24 hours following use, red-tinged urine is typical. Report prolonged irritable bladder symptoms or prolonged passage of red-colored urine immediately to your doctor.
• You or your partner should not become pregnant while you are using Valstar. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with Valstar. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while using Valstar, call your doctor.
• Do not use this medication if you
  • have an allergy to Valstar or to any of its inactive ingredients
  • have an allergy to anthracyclines medications or to polyoxyl castor oil
  • currently have urinary tract infection
  • have a small bladder capacity (unable to tolerate a 75 mL within the bladder)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Valstar, there are no specific foods that you must exclude from your diet.

Before receiving Valstar,

• tell your doctor and pharmacist if you are allergic to Valstar, daunorubicin, doxorubicin, epirubicin, or idarubicin; any other medications; or any of the ingredients in Valstar solution. Ask your doctor for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have a urinary tract infection, or if you urinate frequently because you have small bladder. Your doctor will not want you to receive Valstar solution.
• your doctor will look at your bladder before giving vsolution to see if you have a hole in your bladder or a weak bladder wall. If you have these problems, your treatment will need to wait until your bladder has healed.
• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are using Valstar. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with Valstar. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while using Valstar, call your doctor.
• tell your doctor if you are breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

You or your partner should not become pregnant while you are using Valstar. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with Valstar. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while using Valstar, call your doctor.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Valstar crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Valstar.

• This medication is available in an injectable form to be given directly into a the bladder by a healthcare professional.
• Hold the drug in the bladder for 2 hours before urinating.
• At the end of two hours, you should void (urinate).
• Maintain adequate hydration following treatment.

Valstar is recommended at a dose of 800 mg administered into the bladder once a week for 6 weeks.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

HEPATOTOXICITY

HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID AND ITS DERIVATIVES. EXPERIENCE HAS INDICATED THAT CHILDREN UNDER THE AGE OF TWO YEARS ARE AT A CONSIDERABLY INCREASED RISK OF DEVELOPING FATAL HEPATOTOXICITY, ESPECIALLY THOSE ON MULTIPLE ANTICONVULSANTS, THOSE WITH CONGENITAL METABOLIC DISORDERS, THOSE WITH SEVERE SEIZURE DISORDERS ACCOMPANIED BY MENTAL RETARDATION, AND THOSE WITH ORGANIC BRAIN DISEASE. WHEN VALPROATE IS USED IN THIS PATIENT GROUP, IT SHOULD BE USED WITH EXTREME CAUTION AND AS A SOLE AGENT. THE BENEFITS OF THERAPY SHOULD BE WEIGHED AGAINST THE RISKS. ABOVE THIS AGE GROUP, EXPERIENCE IN EPILEPSY HAS INDICATED THAT THE INCIDENCE OF FATAL HEPATOTOXICITY DECREASES CONSIDERABLY IN PROGRESSIVELY OLDER PATIENT GROUPS.

THESE INCIDENTS USUALLY HAVE OCCURRED DURING THE FIRST SIX MONTHS OF TREATMENT. SERIOUS OR FATAL HEPATOTOXICITY MAY BE PRECEDED BY NON-SPECIFIC SYMPTOMS SUCH AS MALAISE, WEAKNESS, LETHARGY, FACIAL EDEMA, ANOREXIA, AND VOMITING. IN PATIENTS WITH EPILEPSY, A LOSS OF SEIZURE CONTROL MAY ALSO OCCUR. PATIENTS SHOULD BE MONITORED CLOSELY FOR APPEARANCE OF THESE SYMPTOMS. LIVER FUNCTION TESTS SHOULD BE PERFORMED PRIOR TO THERAPY AND AT FREQUENT INTERVALS THEREAFTER, ESPECIALLY DURING THE FIRST SIX MONTHS.

TERATOGENICITY

VALPROATE CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF VALPROATE PRODUCTS IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS. THIS IS ESPECIALLY IMPORTANT WHEN THE TREATMENT OF A SPONTANEOUSLY REVERSIBLE CONDITION NOT ORDINARILY ASSOCIATED WITH PERMANENT INJURY OR RISK OF DEATH (E.G., MIGRAINE) IS CONTEMPLATED.

PANCREATITIS

CASES OF LIFE-THREATENING PANCREATITIS HAVE BEEN REPORTED IN BOTH CHILDREN AND ADULTS RECEIVING VALPROATE. SOME OF THE CASES HAVE BEEN DESCRIBED AS HEMORRHAGIC WITH A RAPID PROGRESSION FROM INITIAL SYMPTOMS TO DEATH. CASES HAVE BEEN REPORTED SHORTLY AFTER INITIAL USE AS WELL AS AFTER SEVERAL YEARS OF USE. PATIENTS AND GUARDIANS SHOULD BE WARNED THAT ABDOMINAL PAIN, NAUSEA, VOMITING, AND/OR ANOREXIA CAN BE SYMPTOMS OF PANCREATITIS THAT REQUIRE PROMPT MEDICAL EVALUATION. IF PANCREATITIS IS DIAGNOSED, VALPROATE SHOULD ORDINARILY BE DISCONTINUED. ALTERNATIVE TREATMENT FOR THE UNDERLYING MEDICAL CONDITION SHOULD BE INITIATED AS CLINICALLY INDICATED.