valrubicin


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valrubicin

(val-roo-bi-sin) ,

Valstar

(trade name),

Valtaxin

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: anthracyclines
Pregnancy Category: C

Indications

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

Action

Interferes with DNA synthesis.

Therapeutic effects

Decreased spread of bladder carcinoma.

Pharmacokinetics

Absorption: Action is primarily local; systemic absorption is negligible.
Distribution: Penetrates bladder wall.
Metabolism and Excretion: Excreted by voiding of instillate.
Half-life: Unknown.

Time/action profile (antineoplastic effect)

ROUTEONSET PEAKDURATION
Intra­vesicularrapidunknownperiod of instillation

Contraindications/Precautions

Contraindicated in: Hypersensitivity to anthracyclines or poloxyl castor oil; Known alcohol intolerance; Concurrent urinary tract infection; Patients with small bladder capacity (unable to tolerate 75-mL instillation); Perforated bladder or conditions where the integrity of the bladder mucosa has been compromised; Obstetric / Lactation: Pregnancy and lactation; Recent (within 2 wk) transurethral resection.
Use Cautiously in: Patients with severe irritable bladder symptoms; Patients with childbearing potential; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache
  • malaise
  • weakness

Respiratory

  • pneumonia

Cardiovascular

  • chest pain
  • vasodilation

Gastrointestinal

  • abdominal pain
  • diarrhea
  • flatulence
  • nausea
  • vomiting

Genitourinary

  • bladder spasm (most frequent)
  • cystitis (most frequent)
  • dysuria (most frequent)
  • hematuria (most frequent)
  • red urine (most frequent)
  • urinary frequency (most frequent)
  • urinary incontinence (most frequent)
  • urinary tract infection (most frequent)
  • urinary urgency (most frequent)
  • local burning
  • nocturia
  • urethral pain
  • urinary retention

Dermatologic

  • rash

Fluid and Electrolyte

  • peripheral edema

Hematologic

  • anemia

Metabolic

  • hyperglycemia

Musculoskeletal

  • back pain

Interactions

Drug-Drug interaction

None significant.

Route/Dosage

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

Availability

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

Nursing implications

Nursing assessment

  • Monitor patient for bladder spasms following instillation of valrubicin. May cause spontaneous discharge of intravesical instillate; clamping of the urinary catheter is not advised.
  • Cystoscopy, biopsy, and urine cytology should be performed every 3 mo to monitor patients for disease recurrence or progression.

Potential Nursing Diagnoses

Impaired urinary elimination (Indications)

Implementation

  • high alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double check single, daily, and course-of-therapy dose limits; have second practitioner independently double check original order and dose calculations.
  • Use aseptic technique during instillation to avoid introducing contaminants into the urinary tract or traumatizing the urinary tract mucosa.
    • Administration should be delayed for at least 2 wk after transurethral resection or fulguration.
    • Solution should be prepared in a biologic cabinet. Wear gloves, gown, and goggles while handling medication. Discard equipment in specially designated containers.
  • Intravesicular: Prior to instillation, allow four 5-mL vials of valrubicin to warm slowly to room temperature; do not heat. Withdraw 20 mL from the four vials and dilute with 55 mL of 0.9% NaCl, resulting in 75 mL of diluted valrubicin solution. Solution is clear red. May form a waxy precipitate at temperatures <4°C. If this occurs, warm vial in hand until solution is clear. Do not administer if particulate matter remains. Diluted solution is stable for 12 hr at room temperature. Prepare and store valrubicin solutions in glass, polypropylene, or polyolefin containers and tubing. Cremophor EL in valrubicin may cause leeching from polyvinyl chloride bags and IV tubing.
  • Rate: Insert a urethral catheter into the patient’s bladder, drain the bladder, and instill diluted 75-mL valrubicin solution slowly via gravity flow over several minutes. Withdraw catheter. Patient should retain drug for 2 hr before voiding. All patients should void at the end of 2 hr. Instruct patient to maintain adequate hydration following treatment.
  • Additive Incompatibility: Do not mix with other drugs.

Patient/Family Teaching

  • 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.
  • Caution women of childbearing age not to become pregnant during treatment. Men receiving valrubicin should refrain from engaging in sexual intercourse during therapy. Advise patients to use an effective method of contraception throughout treatment.

Evaluation/Desired Outcomes

  • Decrease in the spread of bladder cancer.

valrubicin

/val·ru·bi·cin/ (val-roo´bĭ-sin″) an antineoplastic that interferes with nucleic acid metabolism and other related biological functions; used intravesically for treatment of bladder carcinoma.

valrubicin

an antibiotic antineoplastic.
indication This drug is used to treat bladder cancer.
contraindications Factors that prohibit the use of this drug include known hypersensitivity to anthracyclines or Cremophor EL, urinary tract infection, and small bladder size.
adverse effects Life-threatening side effects of this drug include thrombocytopenia and leukopenia. Common side effects include anemia, nausea, vomiting, anorexia, diarrhea, urinary tract infection, urinary retention, hematuria, rash, and chest pain.
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References in periodicals archive ?
The use of valrubicin and bacille Calmette-Guerin (BCG) for bladder dysplasia and the use of Photofrin plus photodynamic therapy for esophageal dysplasia were developed largely within the pharmaceutical industry as adjuvant therapies for the treatment of preinvasive neoplastic lesions, rather than for a specific preventive indication.
Efficacy and safety of valrubicin for the treatment of bacillus Calmette-Guerin refractory carcinoma in situ of the bladder.
Valrubicin is the only FDA-approved drug for patients with CIS; it showed a 21% and 8% complete response after 1 and 2 years, respectively.
114] Valrubicin is approved by the FDA for the treatment of BCG-refractory CIS in patients who either refuse or cannot undergo radical cystec-tomy.
The use of valrubicin for the chemoresection of superficial bladder cancer -- a marker lesion study.
You should read the Company's Form 10-K, and the documents that the Company refers to therein and have filed as exhibits, including discussions about valrubicin, with the understanding that actual future results and events may be materially different from what the Company currently expects.
Urology - review criteria: Referral guidelines; BCG therapy for bladder cancer; Urinary FISH Test for Recurrent Bladder Cancer; Valrubicin for carcinoma in-situ of the bladder; Bladder stimulator/Pacemaker implantation; Bladder pacemakers; Bladder Capacity Ultrasound (Post-void Residual Measurements); Circumcision of the adult male; Cystoscopy; Bladder biopsy, transurethral;
VALSTAR, a sterile solution for intravesical instillation of valrubicin, is placed directly into the bladder through a catheter and is administered once a week for six weeks under the supervision of a physician experienced in the use of intravesical cancer chemotherapeutic agents.
VALSTAR, a sterile solution of valrubicin for intravesical instillation, is the only product approved by the FDA for therapy of bacillus Calmette- Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder.
VALSTAR is a sterile solution for intravesical (bladder) instillation of valrubicin, a chemotherapeutic anthracycline derivative.