Generic Name

Valrubicin

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Classification

FDA Approved Indications

• Bacillus Calmette-Guérin (BCG)-refractory carcinoma of the urinary bladder, isolated to the bladder

Mechanism of Action

Valrubicin works by intercalating DNA strands, inhibiting DNA synthesis and leading to cell death, primarily affecting rapidly dividing cancer cells.

Dosage and Administration

Adult: Instill 3 mL of valrubicin solution (about 8.5 mg) into the bladder once weekly for 6 weeks. Assess response; repeat as appropriate.

Pediatric: Not established; use in pediatric patients is not recommended due to lack of studies.

Geriatric: No specific dosage adjustment necessary, but monitor for increased sensitivity to side effects.

Renal Impairment: No specific data; use cautiously, considering renal function.

Hepatic Impairment: No specific data; use cautiously.

Pharmacokinetics

Absorption: Minimal systemic absorption following intravesical administration.

Distribution: Localized; systemic levels are generally low.

Metabolism: Metabolized in the liver via reduction and conjugation.

Excretion: Excreted primarily in urine and bile.

Half Life: Approximately 50 hours in systemic circulation.

Contraindications

• Hypersensitivity to valrubicin or other anthracyclines.
• Active urinary tract infection.

Precautions

• Monitor for signs of bladder irritation or toxicity.
• Use cautiously in patients with compromised renal or hepatic function.
• Assess for hematuria or urinary symptoms before each administration.

Adverse Reactions - Common

• Urinary frequency (Common)
• Urinary urgency (Common)
• Urinary tract irritation (Common)
• Hematuria (Common)

Adverse Reactions - Serious

• Hemorrhagic cystitis (Uncommon)
• Bladder fibrosis or contracture (Rare)
• Allergic reactions (Rare)
• Bone marrow suppression (Rare)

Drug-Drug Interactions

• None well-documented, but caution with other intravesical agents or systemic chemotherapy.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Instruct patient on the purpose of intravesical therapy and expected symptoms.
• Advise reporting urinary symptoms or signs of infection immediately.
• Discuss importance of follow-up cystoscopy.

Special Considerations

Black Box Warnings:

• Potential for local bladder toxicity including hemorrhagic cystitis.

Genetic Factors: No specific genetic considerations.

Lab Test Interference: Urinary cytology tests may be affected.

Overdose Management

Signs/Symptoms: Local bladder inflammation, toxicity, or systemic effects such as cardiotoxicity in rare cases.

Treatment: Supportive care, symptomatic management, and discontinuation of therapy.

Storage and Handling

Storage: Store at room temperature, away from light.

Stability: Stable until the expiry date marked on the package.