Version May 2024
Note: Delay for at least 2 weeks after transurethral resection and/or fulguration.
Bladder cancer: Intravesical: 800 mg once weekly (retain for 2 hours) for 6 weeks.
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
In clinical trials (Ref), treatment was delayed for 1 week for the following adverse events: grade 3 dysuria (not controlled with phenazopyridine), frequency or urgency on treatment day or lasting >24 hours, or grade 2 or 3 hematuria on treatment day or lasting >48 hours, or for bladder infection. For local toxicities < grade 4 (eg, dysuria [not controlled with phenazopyridine] or bladder spasm), anticholinergic therapy (systemic or topical) or topical anesthesia was administered prior to subsequent instillations.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. In general, local adverse reactions occur during or shortly after instillation and resolve within 1 to 7 days.
>10%: Genitourinary: Irritable bladder (88%), urinary frequency (61%), urinary urgency (57%), dysuria (56%), bladder spasm (31%), hematuria (29%; microscopic: 3%; gross hematuria: 1%), bladder pain (28%), urinary incontinence (22%), cystitis (15%), urinary tract infection (15%), red urine discoloration
1% to 10%:
Cardiovascular: Chest pain (3%), vasodilation (2%), peripheral edema (1%)
Central nervous system: Localized burning (5%), headache (4%), malaise (4%), dizziness (3%)
Dermatologic: Skin rash (3%)
Endocrine & metabolic: Hyperglycemia (1%)
Gastrointestinal: Abdominal pain (5%), nausea (5%), diarrhea (3%), vomiting (2%), flatulence (1%)
Genitourinary: Nocturia (7%), urinary retention (4%), urethral pain (3%), pelvic pain (1%)
Hematologic & oncologic: Anemia (2%)
Neuromuscular & skeletal: Weakness (4%), back pain (3%), myalgia (1%)
Respiratory: Pneumonia (1%)
Miscellaneous: Fever (2%)
<1%, postmarketing, and/or case reports: Ageusia, increased nonprotein nitrogen, pruritus, reduced urine flow, skin irritation (local), tenesmus, urethritis
Known hypersensitivity to anthracyclines, polyoxyl castor oil, or any component of the formulation; perforated bladder; active urinary tract infection; small bladder capacity (unable to tolerate a 75 mL instillation).
Concerns related to adverse effects:
• Bladder irritation: Irritable bladder symptoms (spasm or spontaneous emptying) may occur during instillation and retention, and for a brief time after voiding. Clamping of the urinary catheter is not recommended. Use with caution in patients with severe irritable bladder symptoms.
• Urine discoloration: Red-tinged urine may occur for first 24 hours after instillation. Prolonged discoloration should prompt contact with the physician.
Disease-related concerns:
• Bladder perforation: Evaluate bladder status prior to intravesical instillation. Do not administer valrubicin if mucosal integrity of bladder has been compromised or bladder perforation is present; delay treatment until restoration of bladder integrity.
• Bladder procedures: Delay valrubicin therapy for ≥2 weeks after transurethral resection and/or fulguration.
Other warnings/issues:
• Appropriate use: Valrubicin induces complete response in ~20% of patients with BCG-refractory carcinoma in situ. Delaying cystectomy for intravesical treatment may lead to the development of metastatic bladder cancer. While the precise risk for metastatic bladder cancer is unknown, the risk increases the longer cystectomy is delayed. Reconsider cystectomy for recurrence or if complete response to treatment does not occur within 3 months.
• Polyoxyl castor oil: Valrubicin contains polyoxyl castor oil, which may be associated with hypersensitivity reactions. Use is contraindicated in patients with hypersensitivity to polyoxyl castor oil.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravesical [preservative free]:
Valstar: 40 mg/mL (5 mL) [contains alcohol, usp, polyoxyl/peg-35 castor oil(cremophor el)]
Generic: 40 mg/mL (5 mL)
Yes
Solution (Valrubicin Intravesical)
40 mg/mL (per mL): $337.44
Solution (Valstar Intravesical)
40 mg/mL (per mL): $532.77
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
For intravesical use only; not for IV or IM use. Administer through non-PVC tubing due to the polyoxyl castor oil component.
Intravesicular bladder instillation: Insert urinary catheter under aseptic conditions and drain bladder. Instill 800 mg/75 mL (in NS) slowly by gravity flow over several minutes, then remove catheter. Retain in the bladder for 2 hours, then void (some patients may be unable to retain for the full 2 hours). Patients should maintain adequate hydration following treatment.
Hazardous agent (NIOSH 2016 [group 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Bladder cancer: Intravesical treatment of BCG-refractory bladder carcinoma in situ of the urinary bladder when cystectomy would be associated with unacceptable morbidity or mortality.
Valrubicin may be confused with DAUNOrubicin, DOXOrubicin, epirubicin, IDArubicin
Valstar may be confused with Varubi, valsartan
The medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
None known.
There are no known significant interactions.
Females of reproductive potential should use effective contraception during treatment and for 6 months after the final valrubicin dose. Males with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last valrubicin dose.
Based on the mechanism of action and data from animal reproduction studies, in utero exposure to valrubicin may cause fetal harm.
Systemic exposure (eg, with bladder perforation) during human pregnancy may result in fetal harm.
It is not known if valrubicin is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, breast-feeding should be discontinued prior to initiation of therapy.
Evaluate bladder status prior to administration. Monitor cystoscopy, biopsy, and urine cytology every 3 months for recurrence or progression. Monitor for hematuria and for bladder irritation symptoms.
Valrubicin blocks function of DNA topoisomerase II; it inhibits DNA synthesis, causes extensive chromosomal damage, and arrests cell development (G2 phase). Unlike other anthracyclines, valrubicin does not appear to intercalate DNA.
Absorption: Intravesical: Penetrates into bladder wall; negligible systemic absorption (dependent on bladder wall condition; trauma to mucosa may increase absorption, bladder wall perforation may significantly increase absorption and systemic myelotoxicity).
Metabolism: Negligible after intravesical instillation and 2-hour retention
Excretion: Urine (post 2-hour retention): 98.6% as intact drug; 0.4% as N-trifluoroacetyladriamycin)
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