VALSTAR PRESERVATIVE FREE

When 800 mg valrubicin intravesical solution was administered intravesically to patients with carcinoma in situ , valrubicin intravesical solution penetrated into the bladder wall. The mean total anthracycline concentration measured in bladder tissue exceeded the levels causing 90% cytotoxicity to human bladder cells cultured in vitro . During the two-hour dose-retention period, the metabolism of valrubicin intravesical solution to its major metabolites N-trifluoroacetyladriamycin and N-trifluor...

Valrubicin intravesical solution was administered intravesically to a total of 230 patients with transitional cell carcinoma of the bladder, including 205 patients who received multiple weekly doses ranging from 200 to 900 mg. One hundred seventy-nine of the 205 patients received the approved dose and schedule of 800 mg weekly for multiple weeks. Patients receiving valrubicin intravesical solution for refractory carcinoma in situ were monitored for disease recurrence or progression with cystoscopy, biopsy, and urine cytology every 3 months. In the 90 study patients with BCG-refractory carcinom...

The most frequently reported adverse reactions ( > 5%) after administration of valrubicin intravesical solution are urinary frequency, dysuria, urinary urgency, bladder spasm, hematuria, bladder pain, urinary incontinence, cystitis, urinary tract infection, nocturia, local burning symptoms, abdominal pain, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma at us.hikma@primevigilance.com or call 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical T...

Valrubicin intravesical solution is contraindicated in patients with:

• Perforated bladder [see Warnings and Precautions ( 5.2 )]
• Known hypersensitivity to anthracyclines or polyoxyl castor oil
• Active urinary tract infection
• Small bladder capacity and unable to tolerate a 75 mL instillation
• Perforated bladder or compromised bladder mucosa ( 4 , 5.2 )
• Hypersensitivity to anthracyclines or...

• Delaying cystectomy can lead to development of metastatic bladder cancer, which is lethal. ( 5.1 )
• Do not administer valrubicin intravesical solution to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. ( 5.2 , 12.3 )
• Evaluate the status of the bladder before the intravesical instillation of valrubicin intravesical solution. ( 5.3 )
• Use with caution in patients with severe irritable bladder symptoms. ( 5.4 )
• Embryo-Fetal To...

7 DRUG INTERACTIONS No drug interaction studies were conducted.