- Injection, solution, concentrate 40 mg/mL
Inhibits the incorporation of nucleosides into nucleic acids, causing extensive chromosomal damage and arresting cell cycle in G2.
After intravesical administration, penetrates into the bladder wall. Unless the bladder is perforated, only nanogram amounts of the drug are absorbed systemically.
After retention, the drug is almost completely excreted by voiding the instillate.
Indications and Usage
Intravesical treatment of Bacillus Calmette-Guérin–refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
UTI; patients with small bladder capacity (ie, unable to tolerate a 75 mL instillation); hypersensitivity to anthracyclines or polyoxyl castor oil.
Dosage and AdministrationAdults
Intravesically 800 mg once a wk for 6 wk.
- Delay administration at least 2 wk after transurethral resection and/or fulguration.
- Allow installation to warm slowly to room temperature, but do not heat.
- At temperatures below 39°F, polyoxyl castor oil may begin to form a waxy precipitate. If this occurs, warm the vial in the hand until the solution is clear.
- To avoid skin reactions, use of gloves during preparation and administration is recommended.
- To prevent leaching of a hepatotoxic plasticizer from polyvinyl chloride bags and IV tubing, prepare and store solution in glass, polypropylene, or polyolefin containers and tubing. It is recommended that non-DEHP–containing administration sets, such as those that are polyethylene-lined, be used.
- After draining the bladder, 75 mL of diluted valrubicin sterile solution should be instilled slowly via gravity over a period of several minutes. The solution should be retained for 2 h before voiding.
- Patients should maintain adequate hydration after treatment.
- Do not mix with other drugs.
Store in refrigerator at 36° to 46°F. Vials diluted in sodium chloride 0.9% injection are stable for 12 h at temperatures up to 77°F.
None well documented.
Laboratory Test Interactions
None well documented.
Asthenia, headache, malaise (4%); dizziness (3%).
Nausea (5%); diarrhea (3%); vomiting (2%); flatulence (1%).
Any local bladder symptom (88%); urinary frequency (61%); urinary urgency (57%); dysuria (56%); bladder spasm (31%); hematuria (29%); bladder pain (28%); urinary incontinence (22%); cystitis, UTI (15%); nocturia (7%); urinary retention (4%); urethral pain (3%); gross hematuria, pelvic pain (1%).
Local procedural-related burning symptoms (5%).
Hyperglycemia, peripheral edema (1%).
Back pain (3%); myalgia (1%).
Abdominal pain (5%); chest pain (3%); fever (2%).
In patients undergoing transurethral resection of the bladder, determine the status of the bladder before instillation of valrubicin. In case of bladder perforation, delay administration until bladder integrity has been restored.
Category C .
Safety and efficacy not established.
No specific precautions for use of valrubicin in elderly patients who are otherwise in good health.
Delaying cystectomy could lead to fatal metastatic bladder carcinoma.
Complete response only occurs in about 20% of patients with Bacillus Calmette-Guérin–refractory CIS.
Use with caution in patients with irritable bladder symptoms.
Special risk patients
Do not administer to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa is compromised.
Irritable bladder symptoms.
- Instruct patients to report prolonged, irritable bladder symptoms or prolonged passage of red-colored urine immediately to health care provider.
- Instruct men to refrain from sexual activity while receiving valrubicin therapy.
- Advise patients to use an effective contraceptive method during treatment.
Copyright © 2009 Wolters Kluwer Health.