Classifications: antineoplastic; antibiotic; Therapeutic: antineoplastic
Prototype: Doxorubicin hydrochloride
Pregnancy Category: C
40 mg/mL solution
Semisynthetic analog of doxorubicin. It is a cytotoxic antibiotic agent that inhibits the incorporation of nucleosides in
DNA and RNA, resulting in extensive chromosomal damage. Valrubicin interferes with DNA topoisomerase II, which is responsible
for the normal DNA separation of strands and the resealing of those DNA strands.
Valrubicin has higher antitumor efficacy and lower toxicity than doxorubicin.
Intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder.
Hypersensitivity to valrubicin, doxorubicin, anthracyclines, or castor oil; patients with a perforated bladder, concurrent
UTI, active infection; severe irritable bladder symptoms; severe myelosuppression; pregnancy (category C); lactation.
Within 2 wk of a transureteral resection; compromised bladder mucosa; mild-to-moderate myelosuppression; concurrent use
of anticoagulants, or history of bleeding disorders; GI disorders, renal impairment.
Route & Dosage
|BCG-Refractory Bladder Carcinoma in situ
Adult: Intravesically 800 mg once per wk x 6 wk
- Avoid skin reactions by using gloves during preparation/administration.
- Use only glass, polypropylene, or polyolefin containers and tubing.
PREPARE: Slowly warm 4 vials (5 mL each) to room temperature. When a precipitate is initially present, warm vials in hands until
solution clears. Add contents of 4 vials to 55 mL of 0.9% NaCl injection to yield 75 mL of diluted solution.
INSTILL: Aseptically insert a urethral catheter and drain the bladder. Use gravity drainage to instill valrubicin slowly over several
min. Withdraw catheter; instruct patient not to void for 2 h. Note: Do not leave a clamped catheter in place.
- Refrigerate. Do not freeze.
Adverse Effects (≥1%)Body as a Whole:
Abdominal pain, asthenia, back pain, fever, headache, malaise
, myalgia. CNS:
Vasodilation. GI: Diarrhea
, flatulence, nausea, vomiting. Urogenital: Urinary frequency, urgency, dysuria, bladder spasm, hematuria, bladder pain, incontinence, cystitis, UTI,
nocturia, local burning, urethral pain, pelvic pain, gross hematuria, urinary retention. Respiratory: Pneumonia
Rash. Other: Anemia
, hyperglycemia, peripheral edema.
Not absorbed. Distribution:
Penetrates bladder wall. Metabolism:
Not metabolized. Elimination:
Almost completely excreted by voiding the instillate.
Assessment & Drug Effects
- Therapeutic effectiveness: Indicated by regression of the bladder tumor.
- Notify physician if bladder spasms with spontaneous discharge of valrubicin occur during/shortly after instillation.
Patient & Family Education
- Expect red-tinged urine during the first 24 h after administration.
- Report prolonged passage of red-colored urine or prolonged bladder irritation.
- Drink plenty of fluids during 48 h period following administration.
- Use reliable contraception during therapy period (approximately 6 wk).