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

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.

(Generic available)

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

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

Valstar

• Interferes with DNA synthesis.

• Decreased spread of bladder carcinoma.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: anthracyclines

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

Distribution: Penetrates bladder wall.

Metabolism/Excretion: Excreted by voiding of instillate.

Half-life: Unknown.

Valtaxin

(antineoplastic effect)

• 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.

val-ROO-bi-sin

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