Generic Name and Formulations:
Valrubicin 40mg/mL; soln for intravesical instillation after dilution; contains 50% polyoxyl castor oil/50% dehydrated alcohol; preservative-free.

Company:
Endo Pharmaceuticals

Indications for VALSTAR:
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.

Adult Dose for VALSTAR:
Drain bladder before instilliation. 800mg given intravesically via urethral catheter once weekly for 6 weeks. Retain drug for 2 hours before voiding, then void.

Children's Dose for VALSTAR:
Not recommended.

Pharmacological Class:
Anthracycline.

Contraindications:
Concurrent UTI. Small bladder capacity (eg, unable to tolerate a 75mL instillation).

Warnings/Precautions:
Monitor for disease recurrence or progression with cystoscopy, biopsy, and urine cytology every 3 months; if there is not a complete response of CIS to treatment after 3 months or if CIS recurs, cystectomy must be reconsidered. Severe irritable bladder symptoms. Perforated bladder. Bladder mucosa compromised. Delay administration for at least 2 weeks after transurethral resection and/or fulguration. Maintain adequate hydration. Pregnancy (Cat. C); avoid, both males and females should use effective birth control. Nursing mothers: not recommended.

Adverse Reactions:
Bladder symptoms (eg, urinary frequency, dysuria, urinary urgency, spasm, hematuria, pain, incontinence, cystitis, nocturia, local burning, urethral pain, pelvic pain, UTI).

How Supplied:
Single-use vials—4, 24

Indication
VALSTAR® (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 retention.
Patients receiving VALSTAR must be closely monitored for disease recurrence or progression. The recommended eva luation should include cystoscopy, biopsy, and/or urine cytology every 3 months