Valstar Generic Name & Formulations
Legal Class
Rx
General Description
Valrubicin 40mg/mL; soln for intravesical instillation after dilution; contains 50% polyoxyl castor oil/50% dehydrated alcohol; preservative-free.
Pharmacological Class
Anthracycline.
How Supplied
Single-use vials—4, 24
Manufacturer
Valstar Indications
Indications
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.
Valstar Dosage and Administration
Adult
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
Not recommended.
Valstar Contraindications
Contraindications
Concurrent UTI. Small bladder capacity (eg, unable to tolerate a 75mL instillation).
Valstar Boxed Warnings
Not Applicable
Valstar Warnings/Precautions
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.
Valstar Pharmacokinetics
See Literature
Valstar Interactions
Not Applicable
Valstar Adverse Reactions
Adverse Reactions
Bladder symptoms (eg, urinary frequency, dysuria, urinary urgency, spasm, hematuria, pain, incontinence, cystitis, nocturia, local burning, urethral pain, pelvic pain, UTI).
Valstar Clinical Trials
See Literature
Valstar Note
Not Applicable
Valstar Patient Counseling
See Literature