What is Valstar used for? Valstar is used for treatment of patients
with BCG-resistant cancer of the urinary bladder for whom surgical removal of the bladder
is not safe. Treatment with Valstar is through drug instillation into the urinary bladder.
should not be treated with Valstar?
You should not be given Valstar if you have any of the following conditions:
- Known reaction to other drugs that are similar to Valstar or Cremophor® EL
- Urinary tract infection at the time of treatment
- Small bladder capacity (i.e., unable to tolerate a 75ml instillation)
Special Warning(s) with Valstar:
Valstar has been shown to bring about temporary disappearance of cancer in only
about 1 in 5 patients with treatment-resistant bladder cancer. Delaying surgical removal
of all or part of the bladder could lead to the spread of bladder cancer, which is deadly.
The risk of bladder cancer spreading to other parts of the body from the delay of needed
surgery may be difficult to determine but will increase the longer it is delayed.
Your doctor will evaluate and monitor your response to treatment with Valstar to
decide whether surgery should be reconsidered.
Certain conditions of the bladder may delay or prevent treatment with Valstar.
Your doctor will evaluate you to determine if you are a candidate for treatment with
General Precautions with Valstar:
You should discuss with your doctor the risks involved with delaying surgery,
which could lead to bladder cancer spreading to other parts of your body (See Special
Side effects from treatment with Valstar mainly involve irritable bladder
symptoms (e.g., bladder spasm, spontaneous discharge of Valstar) occurring during
treatment with Valstar or shortly after treatment. For the first 24 hours after treatment
with Valstar, most patients have red-colored urine.
Tell your doctor immediately if you experience any continued irritable bladder
symptoms or if you have red-colored urine after the first 24 hours following treatment.
Men and women of childbearing age should use an effective birth control method
during the Valstar treatment period.
Women: Tell your doctor if you are trying to become pregnant, are
already pregnant, or are breast-feeding. You should not become pregnant while being
treated with Valstar.
Men: Do not engage in sexual activity that could lead to pregnancy while being
treated with Valstar.
What are some possible side effects of Valstar? (This is NOT
a complete list of side effects reported with Valstar. Your health care provider can
discuss with you a more complete list of side effects.)
Side effects with Valstar usually occur during or shortly after treatment and
stop within 1 to 7 days after Valstar is removed from the bladder, including:
- Urinating too often
- Difficulty or pain during urination
- Urge to urinate immediately
- Bladder spasm
- Blood in the urine
- Bladder pain
- Inability to control urination
- Swelling of the bladder
- Waking up at night to urinate
- Burning sensation
Most side effects occurring outside the bladder are mild and disappear within 24
hours after treatment. These include stomach pain, nausea and urinary tract infections.
For more detailed information about Valstar, ask your health care provider.
http://www.fda.gov/cder/foi/label/1998/20892lbl.pdf Valstar's Approved
Date Posted: 11/30/98