val-ROO-bi-sin

Therapeutic Classification: antineoplastics

Pharmacologic Classification: anthracyclines

• Intravesicular (bladder instillation) therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom surgery is inappropriate.

• Interferes with DNA synthesis.

• Decreased spread of bladder carcinoma.

Absorption: Action is primarily local; systemic absorption is negligible.

Distribution: Penetrates bladder wall.

Metabolism/Excretion: Excreted by voiding of instillate.

Half-life: Unknown.

(antineoplastic effect)

Contraindicated in:

• Hypersensitivity to anthracyclines or poloxyl castor oil
• Known alcohol intolerance
• Concurrent urinary tract infection
• Small bladder capacity (unable to tolerate 75-mL instillation)
• Perforated bladder or conditions where the integrity of the bladder mucosa has been compromised
• Recent (within 2 wk) transurethral resection.
• OB: Lactation: Pregnancy and lactation

Use Cautiously in:

• Severe irritable bladder symptoms
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established.

CV: chest pain, vasodilation.

Derm: rash.

Endo: hyperglycemia.

F and E: peripheral edema.

GI: abdominal pain, diarrhea, flatulence, nausea, vomiting.

GU: bladder spasm, cystitis, dysuria, hematuria, red urine, urinary frequency, urinary incontinence, urinary tract infection, urinary urgency, local burning, nocturia, urethral pain, urinary retention.

Hemat: anemia.

MS: back pain.

Neuro: dizziness, headache, malaise, weakness.

Resp: pneumonia.

Drug-Drug:

• None reported.

• Intravesicular (Adults): 800 mg instilled into urinary bladder once weekly for 6 wk.

(Generic available)

• Solution for instillation: 40 mg/mL (contains dehydrated alcohol and polyoxyl castor oil);

• Monitor patient for bladder spasms following instillation of valrubicin. May cause spontaneous discharge of intravesical instillate; clamping of the urinary catheter is not advised.
• Cystoscopy, biopsy, and urine cytology should be performed every 3 mo to monitor patients for disease recurrence or progression.

• High Alert:Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double check single, daily, and course-of-therapy dose limits; have second practitioner independently double check original order and dose calculations.
• Use aseptic technique during instillation to avoid introducing contaminants into the urinary tract or traumatizing the urinary tract mucosa.
  • Administration should be delayed for at least 2 wk after transurethral resection or fulguration.
  • Solution should be prepared in a biologic cabinet. Wear gloves, gown, and goggles while handling medication. Discard equipment in specially designated containers.
• Intravesicular: Prior to instillation, allow four 5-mL vials of valrubicin to warm slowly to room temperature; do not heat. Withdraw 20 mL from the four vials and dilute with 55 mL of 0.9% NaCl, resulting in 75 mL of diluted valrubicin solution. Solution is clear red. May form a waxy precipitate at temperatures <4°C. If this occurs, warm vial in hand until solution is clear. Do not administer if particulate matter remains. Diluted solution is stable for 12 hr at room temperature. Prepare and store valrubicin solutions in glass, polypropylene, or polyolefin containers and tubing. Cremophor EL in valrubicin may cause leeching from polyvinyl chloride bags and IV tubing.
• Rate: Insert a urethral catheter into the patient’s bladder, drain the bladder, and instill diluted 75-mL valrubicin solution slowly via gravity flow over several minutes. Withdraw catheter. Patient should retain drug for 2 hr before voiding. All patients should void at the end of 2 hr. Instruct patient to maintain adequate hydration following treatment.
• Additive Incompatibility: Do not mix with other drugs.

• Inform patient that complete responses from valrubicin occur in only 1 in 5 patients and that delaying cystectomy may lead to metastatic bladder cancer, which is fatal. Discuss the risks associated with both procedures and the increased risk the longer cystectomy is delayed.
• Advise patient that major toxicities from valrubicin cause irritable bladder symptoms, which may occur during instillation and retention and for a limited period following voiding. Red-tinged urine is common for the first 24 hr following instillation. Instruct patient to report prolonged irritable bladder symptoms or prolonged passage of red-tinged urine to health care professional immediately.
• Rep: May be teratogenic. Advise females of reproductive potential to use effective contraception during and for 6 mo after last dose and to avoid breastfeeding during and for 2 wk after last dose of valrubicin. Advise males with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose. May impair male fertility.

• Decrease in the spread of bladder cancer.

Valstar

Valtaxin

NDC Code^*

• 67979- Endo Pharmaceuticals Inc.
  • 67979-001- Valstar
    • 67979-001-01- 4 VIAL in 1 CARTON (67979-001-01) > 5 mL in 1 VIAL