(valrubicin) is indicated for intravesical therapy of BCG-refractory carcinoma in
situ of the urinary bladder in patients for whom immediate cystectomy would
be associated with unacceptable morbidity or mortality.
Important Safety Information
- VALSTAR is contraindicated in patients with known hypersensitivity
to anthracyclines or polyoxyl castor oil. VALSTAR should not be administered to
patients with a perforated bladder, compromised bladder mucosa integrity, concurrent
urinary tract infections, or small bladder capacity (unable to tolerate a 75 mL
instillation). The integrity of the bladder should be confirmed prior to instillation
of VALSTAR in those patients who have had procedures with the potential to compromise
the bladder wall.
- Patients should be informed that VALSTAR has been shown to induce complete response
in about 1 in 5 patients with BCG-refractory CIS. Delaying cystectomy could lead
to development of metastatic bladder cancer. If there is not a complete response
of CIS to treatment after 3 months or if CIS recurs, cystectomy must be reconsidered.
- VALSTAR should be administered using aseptic technique under the supervision of
a practitioner experienced in the use of intravesical cancer chemotherapeutic agents.
VALSTAR should be used with caution in patients with severe irritable bladder symptoms.
Patients of reproductive age should be advised to use an effective contraception
method. Myelosuppression is possible if VALSTAR is inadvertently administered systemically
or if significant systemic exposure occurs following intravesical administration
(e.g., in patients with bladder rupture/perforation). If VALSTAR is administered
when bladder rupture or perforation is suspected, weekly monitoring of complete
blood counts should be performed for 3 weeks.
- In clinical trials, the most common local adverse events include urinary frequency,
urinary urgency and dysuria. The most common systemic adverse events include urinary
tract infection, abdominal pain, nausea, asthenia, headache, malaise and urinary
- Patients receiving VALSTAR must be closely monitored for disease recurrence
or progression. The recommended evaluation should include cystoscopy, biopsy, and/or
urine cytology every 3 months.