valrubicin [Injectable]

Adult Dosing

BCG- refractory bladder carcinoma in situ

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

Note: Delay administration at least 2 wk after transurethral resection and/or fulguration

Pediatric Dosing

Safety and effectiveness in pediatric patients have not been established

[Outline]

Adult Dosing
Pediatric Dosing

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

Contraindications ⬆ ⬇

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

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renail impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

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/Breast Feeding ⬆ ⬇

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

Adverse Reactions ⬆ ⬇

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

Clinical Pharmacology ⬆ ⬇

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

Brands and Availability ⬆ ⬇