Adult Dosing

BCG- refractory bladder carcinoma in situ

• 800 mg intravesically qwk x 6 weeks
• Retain in bladder for 2 hrs before voiding

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

• 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

• Hypersensitivity to anthracyclines or polyoxyl castor oil
• Perforated bladder
• Compromised bladder mucosa
• UTI
• Small bladder capacity (unable to tolerate a 75 mL instillation)
• Transurethral resection within 2 weeks
• Fulguration within 2 weeks

• N/A

Renal Dose Adjustment

• Renail impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Administer valrubicin under supervision of a physician experienced in the use of intravesical cancer chemotherapeutic agents
• Delaying cystectomy could lead to development of lethal metastatic bladder cancer
• In patients undergoing transurethral resection of bladder, evaluate bladder status before intravesical instillation of valrubicin
• Inform patients that valrubicin has been shown to induce complete response in only about 20% of patients
• Inform patients that major acute toxicities are related to irritable bladder symptoms that may occur during instillation and retention of drug and for a limited period following voiding
• Bladder spasm and spontaneous discharge of the intravesical instillate may occur. Use with caution if severe irritable bladder symptoms
• Men should avoid intercourse during therapy. Use effective form of contraception during therapy in patients of reproductive age

Pregnancy Category:C

Breastfeeding: Safety unknown. Valrubicin is highly lipophilic and any exposure of infants could cause serious adverse events. Discontinue nursing before starting therapy

• GU: Local bladder symptoms, urinary frequency, dysuria, urinary urgency, bladder spasm, hematuria, bladder pain, urinary incontinence, cystitis, nocturia, local burning, urethral pain, UTI, gross hematuria, pelvic pain
• CNS: Asthenia, headache, malaise, dizziness
• CV: Vasodilation
• GI: Diarrhea, vomiting, nausea, flatulence, abdominal pain
• HEMA: Anemia
• RESP: Pneumonia
• MUSC: Back pain, myalgia
• MISC: Hyperglycemia, peripheral edema, chest pain, fever

• Anthracyclines: Inhibits the incorporation of nucleosides into nucleic acids, causes chromosomal damage, inhibits DNA synthesis and topoisomerase II activity
• Minimal systemic absorption with intravesical administration
• Not metabolized
• After retention, the drug is almost completely excreted by voiding the instillate
• Half-life: Unknown

US Trade Name(s)

• Valstar

US Availability

Valstar

• INJ: 200 mg/5 mL

Canadian Trade Name(s)

• Valtaxin

Canadian Availability

Valtaxin

• INJ: 200 mg/5 mL

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Hematology/Oncology

Antineoplastics

Antibiotics/Antineoplastics

Urologic

Anthracycline