VALSTARTM (valrubicin) means confidence in a demonstrated safety profile1
2% of patients discontinued VALSTAR due to local bladder symptoms2
- Demonstrated tolerability profile in clinical trials1
- Most local bladder adverse reactions were mild to moderate and resolved within 1 to 7 days1
*Local, treatment-emergent adverse events reported from initial treatment up to the primary evaluation at 3 months. These were graded as mild, moderate, or severe based on the Southwest Oncology Group (SWOG) Toxicity Criteria, and by evaluation of changes in bladder symptoms, clinical laboratory tests, ECGs, and physical examinations.2
- Most systemic adverse reactions were mild and resolved within 24 hours1
- The most commonly reported systemic adverse reactions (≥5%) in clinical trials with VALSTAR (N=230) were urinary tract infection (15%), abdominal pain (5%), and nausea (5%)1
VALSTAR is indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) 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.
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 retention.
Safety and effectiveness in pediatric patients have not been established.
Please see the accompanying full Prescribing Information.
REFERENCES:
1. VALSTAR Prescribing Information. Endo Pharmaceuticals. April 2009.
2. Data on file. Endo Pharmaceuticals.
Potential candidates
for treatment with VALSTARTM (valrubicin)
VALSTAR is the only FDA-approved intravesical therapy indicated for BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.1
Immediate cystectomy may be associated with unacceptable risk of morbidity or mortality in some patients
Patients with multiple comorbidities1,2
- Cardiovascular or cerebrovascular disease
- Clotting disorders
- Arrhythmias
- Impaired pulmonary function3
- Concurrent malignancy
Elderly patients have a higher risk of surgical mortality compared with younger patients2
VALSTAR is indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) 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.
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 retention.
Safety and effectiveness in pediatric patients have not been established.
Please see the accompanying full Prescribing Information.
REFERENCES:
1. Steinberg G, Bahnson R, Brosman S, Middleton R, Wajsman Z, Wehle M. Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guérin refractory carcinoma in situ of the bladder. The Valrubicin Study Group. J Urol. 2000;163:761-767.
2. Marchetti A, Wang L, Magar R, et al. Management of patients with Bacilli Calmette-Guérin-refractory carcinoma in situ of the urinary bladder: cost implications of a clinical trial for valrubicin. Clin Ther. 2000;22:422-438.
3. Taylor JA III, Kuchel GA. Bladder cancer in the elderly: clinical outcomes, basic mechanisms, and future research direction. Nat Clin Pract Urol. 2009;6:135-144.
VALSTARTM (valrubicin) should not be administered to the following patients1:
- Patients with a perforated bladder
- Patients with compromised integrity of the bladder mucosa
Contraindications
- Patients who have a concurrent urinary tract infection
- Patients with a small bladder capacity (ie, those who are unable to tolerate a 75 mL instillation)
- Patients with known hypersensitivity to anthracyclines or polyoxyl castor oil
VALSTAR is indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) 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.
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 retention.
Safety and effectiveness in pediatric patients have not been established.
Please see the accompanying full Prescribing Information.
REFERENCE:
1. VALSTAR Prescribing Information. Endo Pharmaceuticals. April 2009.
